Pharmacokinetics of a Once-Daily extended-release formulation of pramipexole in healthy male volunteers: Three studies
Background: Pramipexole is a dopamine agonist used in the treatment of Parkinson's disease. The currently available immediate-release (IR) formulation is taken orally 3 times daily. Objectives: These studies were conducted to evaluate the pharmacokinetic properties of a variety of prototypes fo...
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| Published in | Clinical therapeutics Vol. 31; no. 11; pp. 2698 - 2711 |
|---|---|
| Main Authors | , , , |
| Format | Journal Article |
| Language | English |
| Published |
Bridgewater, NJ
EM Inc USA
01.11.2009
Elsevier Elsevier Limited |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0149-2918 1879-114X 1879-114X |
| DOI | 10.1016/j.clinthera.2009.10.018 |
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| Abstract | Background: Pramipexole is a dopamine agonist used in the treatment of Parkinson's disease. The currently available immediate-release (IR) formulation is taken orally 3 times daily.
Objectives: These studies were conducted to evaluate the pharmacokinetic properties of a variety of prototypes for a once-daily extended-release (ER) formulation of pramipexole and to further characterize the prototype whose pharmacokinetics best matched those of the IR formulation.
Methods: Three Phase I studies were conducted, all in healthy adult men aged ≤50 years with a body mass index of 18.5 to 29.9 kg/m
2. In the first study, 7 prototypes of a once-daily ER formulation with various release properties, including rate and pH dependence, were compared with the IR formulation taken 3 times daily to identify the optimal pharmacokinetic resemblance based on predefined criteria derived from plasma AUC
0−24h, C
max, and C
min. In the second study, a level A in vitro/in vivo correlation (IVIVC) suitable for predicting an entire in vivo bioavailability time course based on in vitro dissolution was established and validated, and the single-dose pharmacokinetics of the optimal ER formulation identified in the first study were analyzed for food effect. In the third study, steady-state pharmacokinetics of the optimal ER formulation were assessed across a range of pramipexole doses (0.375–4.5 mg/d), including investigation of the food effect at steady state for the highest dose. Tolerability was assessed throughout all studies based on physical examinations, laboratory measurements, and adverse events (AEs).
Results: The 3 studies included 18, 15, and 39 subjects, respectively. Among the ER prototypes tested at 0.75 mg once daily in study 1, a matrix tablet had the optimal pharmacokinetic resemblance to IR pramipexole 0.25 mg TID, with a geometric mean AUC
0−24h,ss of 17.4 ng·h/mL (vs 16.0 ng·h/mL for the IR formulation), C
max,ss of 0.967 ng/mL (vs 1.09 ng/mL), and C
min,ss of 0.455 ng/mL (vs 0.383 ng/mL). For single-dose ER 0.375 mg administered in the fasted state in study 2, in vivo bioavailability was predictable from in vitro dissolution data, with internal mean absolute percent prediction errors of 3.18% for AUC
0−30h and 4.87% for C
max, and external mean absolute prediction errors of 6.61% and 3.34%, respectively, satisfying current guidelines for a level A IVIVC. For single-dose ER 0.375 mg administered in the fed state, the upper bound of the 90% CI for fed:fasted values was 119.8 for AUC
0–30h (within the bioequivalence limits of 80%–125%) and 134.1 for C
max. At steady state in study 3 (subjects' 5th treatment day), dosing at 0.375 to 4.5 mg in the fasted state was associated with a linear, dose-proportional increase in pharmacokinetic parameters, including AUC
0–24h,ss and C
max,ss. At the highest fasted dose (4.5 mg), the geometric coefficient of variation for interindividual variability at steady state was 30.1% for AUC
0–24h,ss (vs 21.4% for IR pramipexole 1.5 mg TID) and 22.3% for C
max,ss
(vs 19.0%). At steady state, the upper bounds of the 90% CIs for fed:fasted values with ER 4.5 mg were 122.1 for AUC
0–24h and 126.8 for C
max. No serious AEs occurred, and the dropout rate was low.
Conclusions: In these studies in healthy male volunteers, an ER pramipexole formulation was identified that resembled the IR formulation in terms of both pharmacokinetics and tolerability. In patients with Parkinson's disease, once-daily use of an ER formulation may improve the convenience of treatment relative to the IR formulation taken 3 times daily and thus increase compliance. |
|---|---|
| AbstractList | Background: Pramipexole is a dopamine agonist used in the treatment of Parkinson's disease. The currently available immediate-release (IR) formulation is taken orally 3 times daily.
Objectives: These studies were conducted to evaluate the pharmacokinetic properties of a variety of prototypes for a once-daily extended-release (ER) formulation of pramipexole and to further characterize the prototype whose pharmacokinetics best matched those of the IR formulation.
Methods: Three Phase I studies were conducted, all in healthy adult men aged ≤50 years with a body mass index of 18.5 to 29.9 kg/m
2. In the first study, 7 prototypes of a once-daily ER formulation with various release properties, including rate and pH dependence, were compared with the IR formulation taken 3 times daily to identify the optimal pharmacokinetic resemblance based on predefined criteria derived from plasma AUC
0−24h, C
max, and C
min. In the second study, a level A in vitro/in vivo correlation (IVIVC) suitable for predicting an entire in vivo bioavailability time course based on in vitro dissolution was established and validated, and the single-dose pharmacokinetics of the optimal ER formulation identified in the first study were analyzed for food effect. In the third study, steady-state pharmacokinetics of the optimal ER formulation were assessed across a range of pramipexole doses (0.375–4.5 mg/d), including investigation of the food effect at steady state for the highest dose. Tolerability was assessed throughout all studies based on physical examinations, laboratory measurements, and adverse events (AEs).
Results: The 3 studies included 18, 15, and 39 subjects, respectively. Among the ER prototypes tested at 0.75 mg once daily in study 1, a matrix tablet had the optimal pharmacokinetic resemblance to IR pramipexole 0.25 mg TID, with a geometric mean AUC
0−24h,ss of 17.4 ng·h/mL (vs 16.0 ng·h/mL for the IR formulation), C
max,ss of 0.967 ng/mL (vs 1.09 ng/mL), and C
min,ss of 0.455 ng/mL (vs 0.383 ng/mL). For single-dose ER 0.375 mg administered in the fasted state in study 2, in vivo bioavailability was predictable from in vitro dissolution data, with internal mean absolute percent prediction errors of 3.18% for AUC
0−30h and 4.87% for C
max, and external mean absolute prediction errors of 6.61% and 3.34%, respectively, satisfying current guidelines for a level A IVIVC. For single-dose ER 0.375 mg administered in the fed state, the upper bound of the 90% CI for fed:fasted values was 119.8 for AUC
0–30h (within the bioequivalence limits of 80%–125%) and 134.1 for C
max. At steady state in study 3 (subjects' 5th treatment day), dosing at 0.375 to 4.5 mg in the fasted state was associated with a linear, dose-proportional increase in pharmacokinetic parameters, including AUC
0–24h,ss and C
max,ss. At the highest fasted dose (4.5 mg), the geometric coefficient of variation for interindividual variability at steady state was 30.1% for AUC
0–24h,ss (vs 21.4% for IR pramipexole 1.5 mg TID) and 22.3% for C
max,ss
(vs 19.0%). At steady state, the upper bounds of the 90% CIs for fed:fasted values with ER 4.5 mg were 122.1 for AUC
0–24h and 126.8 for C
max. No serious AEs occurred, and the dropout rate was low.
Conclusions: In these studies in healthy male volunteers, an ER pramipexole formulation was identified that resembled the IR formulation in terms of both pharmacokinetics and tolerability. In patients with Parkinson's disease, once-daily use of an ER formulation may improve the convenience of treatment relative to the IR formulation taken 3 times daily and thus increase compliance. Abstract Background: Pramipexole is a dopamine agonist used in the treatment of Parkinson's disease. The currently available immediate-release (IR) formulation is taken orally 3 times daily. Objectives: These studies were conducted to evaluate the pharmacokinetic properties of a variety of prototypes for a once-daily extended-release (ER) formulation of pramipexole and to further characterize the prototype whose pharmacokinetics best matched those of the IR formulation. Methods: Three Phase I studies were conducted, all in healthy adult men aged ≤50 years with a body mass index of 18.5 to 29.9 kg/m2 . In the first study, 7 prototypes of a once-daily ER formulation with various release properties, including rate and pH dependence, were compared with the IR formulation taken 3 times daily to identify the optimal pharmacokinetic resemblance based on predefined criteria derived from plasma AUC0−24h , Cmax , and Cmin . In the second study, a level A in vitro/in vivo correlation (IVIVC) suitable for predicting an entire in vivo bioavailability time course based on in vitro dissolution was established and validated, and the single-dose pharmacokinetics of the optimal ER formulation identified in the first study were analyzed for food effect. In the third study, steady-state pharmacokinetics of the optimal ER formulation were assessed across a range of pramipexole doses (0.375–4.5 mg/d), including investigation of the food effect at steady state for the highest dose. Tolerability was assessed throughout all studies based on physical examinations, laboratory measurements, and adverse events (AEs). Results: The 3 studies included 18, 15, and 39 subjects, respectively. Among the ER prototypes tested at 0.75 mg once daily in study 1, a matrix tablet had the optimal pharmacokinetic resemblance to IR pramipexole 0.25 mg TID, with a geometric mean AUC0−24h,ss of 17.4 ng·h/mL (vs 16.0 ng·h/mL for the IR formulation), Cmax,ss of 0.967 ng/mL (vs 1.09 ng/mL), and Cmin,ss of 0.455 ng/mL (vs 0.383 ng/mL). For single-dose ER 0.375 mg administered in the fasted state in study 2, in vivo bioavailability was predictable from in vitro dissolution data, with internal mean absolute percent prediction errors of 3.18% for AUC0−30h and 4.87% for Cmax , and external mean absolute prediction errors of 6.61% and 3.34%, respectively, satisfying current guidelines for a level A IVIVC. For single-dose ER 0.375 mg administered in the fed state, the upper bound of the 90% CI for fed:fasted values was 119.8 for AUC0–30h (within the bioequivalence limits of 80%–125%) and 134.1 for Cmax . At steady state in study 3 (subjects' 5th treatment day), dosing at 0.375 to 4.5 mg in the fasted state was associated with a linear, dose-proportional increase in pharmacokinetic parameters, including AUC0–24h,ss and Cmax,ss . At the highest fasted dose (4.5 mg), the geometric coefficient of variation for interindividual variability at steady state was 30.1% for AUC0–24h,ss (vs 21.4% for IR pramipexole 1.5 mg TID) and 22.3% for Cmax,ss (vs 19.0%). At steady state, the upper bounds of the 90% CIs for fed:fasted values with ER 4.5 mg were 122.1 for AUC0–24h and 126.8 for Cmax . No serious AEs occurred, and the dropout rate was low. Conclusions: In these studies in healthy male volunteers, an ER pramipexole formulation was identified that resembled the IR formulation in terms of both pharmacokinetics and tolerability. In patients with Parkinson's disease, once-daily use of an ER formulation may improve the convenience of treatment relative to the IR formulation taken 3 times daily and thus increase compliance. Background_ Pramipexole is a dopamine agonist used in the treatment of Parkinson's disease. The currently available immediate-release (IR) formulation is taken orally 3 times daily. Objectives_ These studies were conducted to evaluate the pharmacokinetic properties of a variety of prototypes for a once-daily extended-release (ER) formulation of pramipexole and to further characterize the prototype whose pharmacokinetics best matched those of the IR formulation. Methods_ Three Phase I studies were conducted, all in healthy adult men aged ≤50 years with a body mass index of 18.5 to 29.9 kg/m2 . In the first study, 7 prototypes of a once-daily ER formulation with various release properties, including rate and pH dependence, were compared with the IR formulation taken 3 times daily to identify the optimal pharmacokinetic resemblance based on predefined criteria derived from plasma AUC0-24h, Cmax, and Cmin. In the second study, a level A in vitro/in vivo correlation (IVIVC) suitable for predicting an entire in vivo bioavailability time course based on in vitro dissolution was established and validated, and the single-dose pharmacokinetics of the optimal ER formulation identified in the first study were analyzed for food effect. In the third study, steady-state pharmacokinetics of the optimal ER formulation were assessed across a range of pramipexole doses (0.375-4.5 mg/d), including investigation of the food effect at steady state for the highest dose. Tolerability was assessed throughout all studies based on physical examinations, laboratory measurements, and adverse events (AEs). Results_ The 3 studies included 18, 15, and 39 subjects, respectively. Among the ER prototypes tested at 0.75 mg once daily in study 1, a matrix tablet had the optimal pharmacokinetic resemblance to IR pramipexole 0.25 mg TID, with a geometric mean AUC0-24h,ss of 17.4 ng·h/mL (vs 16.0 ng·h/mL for the IR formulation), Cmax,ss of 0.967 ng/mL (vs 1.09 ng/mL), and Cmin,ss of 0.455 ng/mL (vs 0.383 ng/mL). For single-dose ER 0.375 mg administered in the fasted state in study 2, in vivo bioavailability was predictable from in vitro dissolution data, with internal mean absolute percent prediction errors of 3.18% for AUC0-30h and 4.87% for Cmax, and external mean absolute prediction errors of 6.61% and 3.34%, respectively, satisfying current guidelines for a level A IVIVC. For single-dose ER 0.375 mg administered in the fed state, the upper bound of the 90% CI for fed:fasted values was 119.8 for AUC0-30h (within the bioequivalence limits of 80%-125%) and 134.1 for Cmax. At steady state in study 3 (subjects' 5th treatment day), dosing at 0.375 to 4.5 mg in the fasted state was associated with a linear, dose-proportional increase in pharmacokinetic parameters, including AUC0-24h,ss and Cmax,ss. At the highest fasted dose (4.5 mg), the geometric coefficient of variation for interindividual variability at steady state was 30.1% for AUC0-24h,ss (vs 21.4% for IR pramipexole 1.5 mg TID) and 22.3% for Cmax,ss (vs 19.0%). At steady state, the upper bounds of the 90% CIs for fed:fasted values with ER 4.5 mg were 122.1 for AUC0-24h and 126.8 for Cmax. No serious AEs occurred, and the dropout rate was low. Conclusions_ In these studies in healthy male volunteers, an ER pramipexole formulation was identified that resembled the IR formulation in terms of both pharmacokinetics and tolerability. In patients with Parkinson's disease, once-daily use of an ER formulation may improve the convenience of treatment relative to the IR formulation taken 3 times daily and thus increase compliance. Pramipexole is a dopamine agonist used in the treatment of Parkinson's disease. The currently available immediate-release (IR) formulation is taken orally 3 times daily.BACKGROUNDPramipexole is a dopamine agonist used in the treatment of Parkinson's disease. The currently available immediate-release (IR) formulation is taken orally 3 times daily.These studies were conducted to evaluate the pharmacokinetic properties of a variety of prototypes for a once-daily extended-release (ER) formulation of pramipexole and to further characterize the prototype whose pharmacokinetics best matched those of the IR formulation.OBJECTIVESThese studies were conducted to evaluate the pharmacokinetic properties of a variety of prototypes for a once-daily extended-release (ER) formulation of pramipexole and to further characterize the prototype whose pharmacokinetics best matched those of the IR formulation.Three Phase I studies were conducted, all in healthy adult men aged <or=50 years with a body mass index of 18.5 to 29.9 kg/m(2). In the first study, 7 prototypes of a once-daily ER formulation with various release properties, including rate and pH dependence, were compared with the IR formulation taken 3 times daily to identify the optimal pharmacokinetic resemblance based on predefined criteria derived from plasma AUC(0-24h), C(max), and C(min). In the second study, a level A in vitro/in vivo correlation (IVIVC) suitable for predicting an entire in vivo bioavailability time course based on in vitro dissolution was established and validated, and the single-dose pharmacokinetics of the optimal ER formulation identified in the first study were analyzed for food effect. In the third study, steady-state pharmacokinetics of the optimal ER formulation were assessed across a range of pramipexole doses (0.375-4.5 mg/d), including investigation of the food effect at steady state for the highest dose. Tolerability was assessed throughout all studies based on physical examinations, laboratory measurements, and adverse events (AEs).METHODSThree Phase I studies were conducted, all in healthy adult men aged <or=50 years with a body mass index of 18.5 to 29.9 kg/m(2). In the first study, 7 prototypes of a once-daily ER formulation with various release properties, including rate and pH dependence, were compared with the IR formulation taken 3 times daily to identify the optimal pharmacokinetic resemblance based on predefined criteria derived from plasma AUC(0-24h), C(max), and C(min). In the second study, a level A in vitro/in vivo correlation (IVIVC) suitable for predicting an entire in vivo bioavailability time course based on in vitro dissolution was established and validated, and the single-dose pharmacokinetics of the optimal ER formulation identified in the first study were analyzed for food effect. In the third study, steady-state pharmacokinetics of the optimal ER formulation were assessed across a range of pramipexole doses (0.375-4.5 mg/d), including investigation of the food effect at steady state for the highest dose. Tolerability was assessed throughout all studies based on physical examinations, laboratory measurements, and adverse events (AEs).The 3 studies included 18, 15, and 39 subjects, respectively. Among the ER prototypes tested at 0.75 mg once daily in study 1, a matrix tablet had the optimal pharmacokinetic resemblance to IR pramipexole 0.25 mg TID, with a geometric mean AUC(0-24h,ss) of 17.4 ng.h/mL (vs 16.0 ng.h/mL for the IR formulation), C(max,ss) of 0.967 ng/mL (vs 1.09 ng/mL), and C(min,ss) of 0.455 ng/mL (vs 0.383 ng/mL). For single-dose ER 0.375 mg administered in the fasted state in study 2, in vivo bioavailability was predictable from in vitro dissolution data, with internal mean absolute percent prediction errors of 3.18% for AUC(0-30h) and 4.87% for C(max), and external mean absolute prediction errors of 6.61% and 3.34%, respectively, satisfying current guidelines for a level A IVIVC. For single-dose ER 0.375 mg administered in the fed state, the upper bound of the 90% CI for fed:fasted values was 119.8 for AUC(0-30h) (within the bioequivalence limits of 80%-125%) and 134.1 for C(max). At steady state in study 3 (subjects' 5th treatment day), dosing at 0.375 to 4.5 mg in the fasted state was associated with a linear, dose-proportional increase in pharmacokinetic parameters, including AUC(0-24h,ss) and C(max,ss). At the highest fasted dose (4.5 mg), the geometric coefficient of variation for interindividual variability at steady state was 30.1% for AUC(0-24h,ss) (vs 21.4% for IR pramipexole 1.5 mg TID) and 22.3% for C(max,ss) (vs 19.0%). At steady state, the upper bounds of the 90% CIs for fed:fasted values with ER 4.5 mg were 122.1 for AUC(0-24h) and 126.8 for C(max). No serious AEs occurred, and the dropout rate was low.RESULTSThe 3 studies included 18, 15, and 39 subjects, respectively. Among the ER prototypes tested at 0.75 mg once daily in study 1, a matrix tablet had the optimal pharmacokinetic resemblance to IR pramipexole 0.25 mg TID, with a geometric mean AUC(0-24h,ss) of 17.4 ng.h/mL (vs 16.0 ng.h/mL for the IR formulation), C(max,ss) of 0.967 ng/mL (vs 1.09 ng/mL), and C(min,ss) of 0.455 ng/mL (vs 0.383 ng/mL). For single-dose ER 0.375 mg administered in the fasted state in study 2, in vivo bioavailability was predictable from in vitro dissolution data, with internal mean absolute percent prediction errors of 3.18% for AUC(0-30h) and 4.87% for C(max), and external mean absolute prediction errors of 6.61% and 3.34%, respectively, satisfying current guidelines for a level A IVIVC. For single-dose ER 0.375 mg administered in the fed state, the upper bound of the 90% CI for fed:fasted values was 119.8 for AUC(0-30h) (within the bioequivalence limits of 80%-125%) and 134.1 for C(max). At steady state in study 3 (subjects' 5th treatment day), dosing at 0.375 to 4.5 mg in the fasted state was associated with a linear, dose-proportional increase in pharmacokinetic parameters, including AUC(0-24h,ss) and C(max,ss). At the highest fasted dose (4.5 mg), the geometric coefficient of variation for interindividual variability at steady state was 30.1% for AUC(0-24h,ss) (vs 21.4% for IR pramipexole 1.5 mg TID) and 22.3% for C(max,ss) (vs 19.0%). At steady state, the upper bounds of the 90% CIs for fed:fasted values with ER 4.5 mg were 122.1 for AUC(0-24h) and 126.8 for C(max). No serious AEs occurred, and the dropout rate was low.In these studies in healthy male volunteers, an ER pramipexole formulation was identified that resembled the IR formulation in terms of both pharmacokinetics and tolerability. In patients with Parkinson's disease, once-daily use of an ER formulation may improve the convenience of treatment relative to the IR formulation taken 3 times daily and thus increase compliance.CONCLUSIONSIn these studies in healthy male volunteers, an ER pramipexole formulation was identified that resembled the IR formulation in terms of both pharmacokinetics and tolerability. In patients with Parkinson's disease, once-daily use of an ER formulation may improve the convenience of treatment relative to the IR formulation taken 3 times daily and thus increase compliance. Pramipexole is a dopamine agonist used in the treatment of Parkinson's disease. The currently available immediate-release (IR) formulation is taken orally 3 times daily. These studies were conducted to evaluate the pharmacokinetic properties of a variety of prototypes for a once-daily extended-release (ER) formulation of pramipexole and to further characterize the prototype whose pharmacokinetics best matched those of the IR formulation. Three Phase I studies were conducted, all in healthy adult men aged <or=50 years with a body mass index of 18.5 to 29.9 kg/m(2). In the first study, 7 prototypes of a once-daily ER formulation with various release properties, including rate and pH dependence, were compared with the IR formulation taken 3 times daily to identify the optimal pharmacokinetic resemblance based on predefined criteria derived from plasma AUC(0-24h), C(max), and C(min). In the second study, a level A in vitro/in vivo correlation (IVIVC) suitable for predicting an entire in vivo bioavailability time course based on in vitro dissolution was established and validated, and the single-dose pharmacokinetics of the optimal ER formulation identified in the first study were analyzed for food effect. In the third study, steady-state pharmacokinetics of the optimal ER formulation were assessed across a range of pramipexole doses (0.375-4.5 mg/d), including investigation of the food effect at steady state for the highest dose. Tolerability was assessed throughout all studies based on physical examinations, laboratory measurements, and adverse events (AEs). The 3 studies included 18, 15, and 39 subjects, respectively. Among the ER prototypes tested at 0.75 mg once daily in study 1, a matrix tablet had the optimal pharmacokinetic resemblance to IR pramipexole 0.25 mg TID, with a geometric mean AUC(0-24h,ss) of 17.4 ng.h/mL (vs 16.0 ng.h/mL for the IR formulation), C(max,ss) of 0.967 ng/mL (vs 1.09 ng/mL), and C(min,ss) of 0.455 ng/mL (vs 0.383 ng/mL). For single-dose ER 0.375 mg administered in the fasted state in study 2, in vivo bioavailability was predictable from in vitro dissolution data, with internal mean absolute percent prediction errors of 3.18% for AUC(0-30h) and 4.87% for C(max), and external mean absolute prediction errors of 6.61% and 3.34%, respectively, satisfying current guidelines for a level A IVIVC. For single-dose ER 0.375 mg administered in the fed state, the upper bound of the 90% CI for fed:fasted values was 119.8 for AUC(0-30h) (within the bioequivalence limits of 80%-125%) and 134.1 for C(max). At steady state in study 3 (subjects' 5th treatment day), dosing at 0.375 to 4.5 mg in the fasted state was associated with a linear, dose-proportional increase in pharmacokinetic parameters, including AUC(0-24h,ss) and C(max,ss). At the highest fasted dose (4.5 mg), the geometric coefficient of variation for interindividual variability at steady state was 30.1% for AUC(0-24h,ss) (vs 21.4% for IR pramipexole 1.5 mg TID) and 22.3% for C(max,ss) (vs 19.0%). At steady state, the upper bounds of the 90% CIs for fed:fasted values with ER 4.5 mg were 122.1 for AUC(0-24h) and 126.8 for C(max). No serious AEs occurred, and the dropout rate was low. In these studies in healthy male volunteers, an ER pramipexole formulation was identified that resembled the IR formulation in terms of both pharmacokinetics and tolerability. In patients with Parkinson's disease, once-daily use of an ER formulation may improve the convenience of treatment relative to the IR formulation taken 3 times daily and thus increase compliance. |
| Author | Könen-Bergmann, Michael Schepers, Cornelia Jenner, Peter Haertter, Sebastian |
| Author_xml | – sequence: 1 givenname: Peter surname: Jenner fullname: Jenner, Peter email: peter.jenner@kcl.ac.uk organization: Neurodegenerative Disease Research Centre, School of Biomedical and Health Sciences, King's College London, London, United Kingdom – sequence: 2 givenname: Michael surname: Könen-Bergmann fullname: Könen-Bergmann, Michael organization: Department of Clinical Research, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany – sequence: 3 givenname: Cornelia surname: Schepers fullname: Schepers, Cornelia organization: Department of Medical Data Services/Biostatistics, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany – sequence: 4 givenname: Sebastian surname: Haertter fullname: Haertter, Sebastian organization: Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22280242$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/20110012$$D View this record in MEDLINE/PubMed |
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| Cites_doi | 10.1056/NEJM199309303291408 10.1007/978-3-7091-0579-5_10 10.1001/archneur.61.7.1044 10.1046/j.1471-4159.2003.02109.x 10.1002/mds.870130207 10.1016/S1474-4422(06)70521-X 10.1002/j.1552-4604.1997.tb04330.x 10.1002/mds.20041 10.1212/WNL.56.suppl_5.S1 10.1093/brain/awf214 10.1016/j.expneurol.2004.11.013 10.1002/mds.22022 10.1136/jnnp.2008.152579 10.1016/j.neuropharm.2007.07.007 10.1111/j.1600-0404.1998.tb00633.x 10.1212/01.wnl.0000258660.74391.c1 10.1016/0378-4347(96)00124-7 10.1002/mds.20602 10.1002/mds.870100108 10.1517/17425255.4.2.193 10.1046/j.1468-1331.2000.0070s1015.x 10.1586/14737175.6.9.1275 10.1212/WNL.49.1.162 10.1001/archneur.62.6.905 |
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| Keywords | steady state Parkinson's disease pramipexole immediate release extended release Agonist Parkinson disease Pramipexole Formulation Immediate release form Single daily dose Degenerative disease Human Nervous system diseases Healthy subject Controlled release form Neuroprotective agent Antiparkinson agent Cerebral disorder D2 Dopamine receptor Central nervous system disease Dopamine agonist Dosage form Daily dose Pharmacokinetics Extrapyramidal syndrome |
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| References | Stocchi, Ruggieri, Vacca, Olanow (bib26) 2002; 125 Lieberman, Ranhosky, Korts (bib7) 1997; 49 bib14 bib15 bib12 Stocchi, Vacca, Ruggieri, Olanow (bib29) 2005; 62 Woitalla, Müller, Benz (bib4) 2004 bib11 Holloway, Shoulson, Fahn (bib8) 2004; 61 Poewe (bib31) 2008; 8 Nyholm, Lennernas (bib32) 2008; 4 Lau, Selenka, Hanson (bib13) 1996; 683 Grosset, Bone, Grosset (bib23) 2005; 20 Goto, Otani, Grace (bib16) 2007; 53 Venton, Zhang, Garris (bib17) 2003; 87 Leopold, Polansky, Hurka (bib24) 2004; 19 Morgan, Sethi (bib5) 2006; 6 Hubble (bib10) 2000; 7 Chase, Baronti, Fabbrini (bib20) 1989; 39 Olanow, Watts, Koller (bib2) 2001; 56 bib25 Gancher, Nutt, Woodward (bib27) 1995; 10 Fahn (bib30) 2008; 64 Wright, Sisson, Ichhpurani, Peters (bib9) 1997; 37 Wolters, Lees, Volkmann (bib22) 2008; 13 Calne (bib1) 1993; 329 Jenner (bib21) 2008; 23 Pahwa, Stacy, Factor (bib6) 2007; 68 Bibbiani, Costantini, Patel, Chase (bib19) 2005; 192 Olanow, Obeso, Stocchi (bib3) 2006; 5 Nilsson, Hansson, Johansson (bib28) 1998; 97 Pearce, Banerji, Jenner, Marsden (bib18) 1998; 13 Chase (10.1016/j.clinthera.2009.10.018_bib20) 1989; 39 Olanow (10.1016/j.clinthera.2009.10.018_bib2) 2001; 56 Wright (10.1016/j.clinthera.2009.10.018_bib9) 1997; 37 Stocchi (10.1016/j.clinthera.2009.10.018_bib29) 2005; 62 Gancher (10.1016/j.clinthera.2009.10.018_bib27) 1995; 10 Poewe (10.1016/j.clinthera.2009.10.018_bib31) 2008; 8 Olanow (10.1016/j.clinthera.2009.10.018_bib3) 2006; 5 Lau (10.1016/j.clinthera.2009.10.018_bib13) 1996; 683 Holloway (10.1016/j.clinthera.2009.10.018_bib8) 2004; 61 Grosset (10.1016/j.clinthera.2009.10.018_bib23) 2005; 20 Nilsson (10.1016/j.clinthera.2009.10.018_bib28) 1998; 97 Goto (10.1016/j.clinthera.2009.10.018_bib16) 2007; 53 Hubble (10.1016/j.clinthera.2009.10.018_bib10) 2000; 7 Bibbiani (10.1016/j.clinthera.2009.10.018_bib19) 2005; 192 Pearce (10.1016/j.clinthera.2009.10.018_bib18) 1998; 13 Woitalla (10.1016/j.clinthera.2009.10.018_bib4) 2004 Stocchi (10.1016/j.clinthera.2009.10.018_bib26) 2002; 125 Fahn (10.1016/j.clinthera.2009.10.018_bib30) 2008; 64 Jenner (10.1016/j.clinthera.2009.10.018_bib21) 2008; 23 Leopold (10.1016/j.clinthera.2009.10.018_bib24) 2004; 19 Pahwa (10.1016/j.clinthera.2009.10.018_bib6) 2007; 68 Wolters (10.1016/j.clinthera.2009.10.018_bib22) 2008; 13 Venton (10.1016/j.clinthera.2009.10.018_bib17) 2003; 87 Lieberman (10.1016/j.clinthera.2009.10.018_bib7) 1997; 49 Morgan (10.1016/j.clinthera.2009.10.018_bib5) 2006; 6 Calne (10.1016/j.clinthera.2009.10.018_bib1) 1993; 329 Nyholm (10.1016/j.clinthera.2009.10.018_bib32) 2008; 4 |
| References_xml | – volume: 4 start-page: 193 year: 2008 end-page: 203 ident: bib32 article-title: Irregular gastrointestinal drug absorption in Parkinson's disease publication-title: Expert Opin Drug Metab Toxicol. – volume: 23 start-page: S585 year: 2008 end-page: S598 ident: bib21 article-title: Preventing and controlling dyskinesia in Parkinson's disease—a view of current knowledge and future opportunities publication-title: Mov Disord. – volume: 125 start-page: 2058 year: 2002 end-page: 2066 ident: bib26 article-title: Prospective randomized trial of lisuride infusion versus oral levodopa in patients with Parkinson's disease publication-title: Brain. – volume: 56 start-page: S1 year: 2001 end-page: S88 ident: bib2 article-title: An algorithm (decision tree) for the management of Parkinson's disease (2001): Treatment guidelines publication-title: Neurology. – volume: 13 start-page: 234 year: 1998 end-page: 241 ident: bib18 article-title: De novo administration of ropinirole and bromocriptine induces less dyskinesia than L-dopa in the MPTP-treated marmoset publication-title: Mov Disord. – volume: 6 start-page: 1275 year: 2006 end-page: 1282 ident: bib5 article-title: Rotigotine for the treatment of Parkinson's disease publication-title: Expert Rev Neurother. – volume: 8 start-page: 238 year: 2008 end-page: 241 ident: bib31 article-title: When a Parkinson's disease patient starts to hallucinate publication-title: Pract Neurol. – volume: 64 start-page: S56 year: 2008 end-page: S64 ident: bib30 article-title: How do you treat motor complications in Parkinson's disease: Medicine, surgery, or both? publication-title: Ann Neurol. – volume: 19 start-page: 513 year: 2004 end-page: 517 ident: bib24 article-title: Drug adherence in Parkinson's disease publication-title: Mov Disord. – volume: 97 start-page: 175 year: 1998 end-page: 183 ident: bib28 article-title: Long-term intraduodenal infusion of a water based levodopacarbidopa dispersion in very advanced Parkinson's disease publication-title: Acta Neurol Scand. – ident: bib12 article-title: Guidance for industry. Extended release oral dosage forms: Development, evaluation, and application of in vitro/ in vivo correlations – ident: bib14 article-title: Guidance for industry. Food-effect bioavailability and fed bioequivalence studies – volume: 53 start-page: 583 year: 2007 end-page: 587 ident: bib16 article-title: The Yin and Yang of dopamine release: A new perspective publication-title: Neuropharmacology. – volume: 87 start-page: 1284 year: 2003 end-page: 1295 ident: bib17 article-title: Real-time decoding of dopamine concentration changes in the caudate-putamen during tonic and phasic firing [published correction appears in publication-title: J Neurochem. – volume: 5 start-page: 677 year: 2006 end-page: 687 ident: bib3 article-title: Continuous dopaminereceptor treatment of Parkinson's disease: Scientific rationale and clinical implications publication-title: Lancet Neurol. – volume: 683 start-page: 209 year: 1996 end-page: 216 ident: bib13 article-title: Determination of pramipexole (U-98,528) in human plasma by high-performance liquid chromatography with atmospheric pressure chemical ionization tandem mass spectrometry publication-title: J Chromatogr B Biomed Appl. – volume: 61 start-page: 1044 year: 2004 end-page: 1053 ident: bib8 article-title: Pramipexole vs levodopa as initial treatment for Parkinson disease: A 4-year randomized controlled trial [published correction appears in publication-title: Arch Neurol. – volume: 62 start-page: 905 year: 2005 end-page: 910 ident: bib29 article-title: Intermittent vs continuous levodopa administration in patients with advanced Parkinson disease: A clinical and pharmacokinetic study publication-title: Arch Neurol. – volume: 68 start-page: 1108 year: 2007 end-page: 1115 ident: bib6 article-title: Ropinirole 24-hour prolonged release: Randomized, controlled study in advanced Parkinson disease publication-title: Neurology. – volume: 13 start-page: 1 year: 2008 end-page: 14 ident: bib22 article-title: Managing Parkinson's disease with continuous dopaminergic stimulation publication-title: CNS Spectr. – volume: 10 start-page: 37 year: 1995 end-page: 43 ident: bib27 article-title: Apomorphine infusional therapy in Parkinson's disease: Clinical utility and lack of tolerance publication-title: Mov Disord. – volume: 329 start-page: 1021 year: 1993 end-page: 1027 ident: bib1 article-title: Treatment of Parkinson's disease publication-title: N Engl J Med. – volume: 49 start-page: 162 year: 1997 end-page: 168 ident: bib7 article-title: Clinical evaluation of pramipexole in advanced Parkinson's disease: Results of a double-blind, placebo-controlled, parallel-group study publication-title: Neurology. – volume: 37 start-page: 520 year: 1997 end-page: 525 ident: bib9 article-title: Steadystate pharmacokinetic properties of pramipexole in healthy volunteers publication-title: J Clin Pharmacol. – volume: 39 start-page: 7 year: 1989 end-page: 10 ident: bib20 article-title: Rationale for continuous dopaminomimetic therapy of Parkinson's disease publication-title: Neurology. – ident: bib25 article-title: UCB brings Neupro® back to all patients in Europe – volume: 20 start-page: 1502 year: 2005 end-page: 1507 ident: bib23 article-title: Suboptimal medication adherence in Parkinson's disease publication-title: Mov Disord. – volume: 7 start-page: 15 year: 2000 end-page: 20 ident: bib10 article-title: Pre-clinical studies of pramipexole: Clinical relevance publication-title: Eur J Neurol. – start-page: 89 year: 2004 end-page: 95 ident: bib4 article-title: Transdermal lisuride delivery in the treatment of Parkinson's disease publication-title: J Neural Transm Suppl. – ident: bib11 article-title: Note for guidance on quality of modified release products: A: Oral dosage forms; B: Transdermal dosage forms. Section I (quality) – ident: bib15 article-title: Note for guidance on the investigation of bioavailability and bioequivalence – volume: 192 start-page: 73 year: 2005 end-page: 78 ident: bib19 article-title: Continuous dopaminergic stimulation reduces risk of motor complications in parkinsonian primates publication-title: Exp Neurol. – volume: 329 start-page: 1021 year: 1993 ident: 10.1016/j.clinthera.2009.10.018_bib1 article-title: Treatment of Parkinson's disease publication-title: N Engl J Med. doi: 10.1056/NEJM199309303291408 – start-page: 89 year: 2004 ident: 10.1016/j.clinthera.2009.10.018_bib4 article-title: Transdermal lisuride delivery in the treatment of Parkinson's disease publication-title: J Neural Transm Suppl. doi: 10.1007/978-3-7091-0579-5_10 – volume: 61 start-page: 1044 year: 2004 ident: 10.1016/j.clinthera.2009.10.018_bib8 article-title: Pramipexole vs levodopa as initial treatment for Parkinson disease: A 4-year randomized controlled trial [published correction appears in Arch Neurol. 2005;62:430] publication-title: Arch Neurol. doi: 10.1001/archneur.61.7.1044 – volume: 87 start-page: 1284 year: 2003 ident: 10.1016/j.clinthera.2009.10.018_bib17 article-title: Real-time decoding of dopamine concentration changes in the caudate-putamen during tonic and phasic firing [published correction appears in J Neurochem. 2004; 89:526] publication-title: J Neurochem. doi: 10.1046/j.1471-4159.2003.02109.x – volume: 13 start-page: 234 year: 1998 ident: 10.1016/j.clinthera.2009.10.018_bib18 article-title: De novo administration of ropinirole and bromocriptine induces less dyskinesia than L-dopa in the MPTP-treated marmoset publication-title: Mov Disord. doi: 10.1002/mds.870130207 – volume: 5 start-page: 677 year: 2006 ident: 10.1016/j.clinthera.2009.10.018_bib3 article-title: Continuous dopaminereceptor treatment of Parkinson's disease: Scientific rationale and clinical implications publication-title: Lancet Neurol. doi: 10.1016/S1474-4422(06)70521-X – volume: 37 start-page: 520 year: 1997 ident: 10.1016/j.clinthera.2009.10.018_bib9 article-title: Steadystate pharmacokinetic properties of pramipexole in healthy volunteers publication-title: J Clin Pharmacol. doi: 10.1002/j.1552-4604.1997.tb04330.x – volume: 19 start-page: 513 year: 2004 ident: 10.1016/j.clinthera.2009.10.018_bib24 article-title: Drug adherence in Parkinson's disease publication-title: Mov Disord. doi: 10.1002/mds.20041 – volume: 56 start-page: S1 issue: Suppl 5 year: 2001 ident: 10.1016/j.clinthera.2009.10.018_bib2 article-title: An algorithm (decision tree) for the management of Parkinson's disease (2001): Treatment guidelines publication-title: Neurology. doi: 10.1212/WNL.56.suppl_5.S1 – volume: 125 start-page: 2058 year: 2002 ident: 10.1016/j.clinthera.2009.10.018_bib26 article-title: Prospective randomized trial of lisuride infusion versus oral levodopa in patients with Parkinson's disease publication-title: Brain. doi: 10.1093/brain/awf214 – volume: 192 start-page: 73 year: 2005 ident: 10.1016/j.clinthera.2009.10.018_bib19 article-title: Continuous dopaminergic stimulation reduces risk of motor complications in parkinsonian primates publication-title: Exp Neurol. doi: 10.1016/j.expneurol.2004.11.013 – volume: 23 start-page: S585 issue: Suppl 3 year: 2008 ident: 10.1016/j.clinthera.2009.10.018_bib21 article-title: Preventing and controlling dyskinesia in Parkinson's disease—a view of current knowledge and future opportunities publication-title: Mov Disord. doi: 10.1002/mds.22022 – volume: 8 start-page: 238 year: 2008 ident: 10.1016/j.clinthera.2009.10.018_bib31 article-title: When a Parkinson's disease patient starts to hallucinate publication-title: Pract Neurol. doi: 10.1136/jnnp.2008.152579 – volume: 53 start-page: 583 year: 2007 ident: 10.1016/j.clinthera.2009.10.018_bib16 article-title: The Yin and Yang of dopamine release: A new perspective publication-title: Neuropharmacology. doi: 10.1016/j.neuropharm.2007.07.007 – volume: 97 start-page: 175 year: 1998 ident: 10.1016/j.clinthera.2009.10.018_bib28 article-title: Long-term intraduodenal infusion of a water based levodopacarbidopa dispersion in very advanced Parkinson's disease publication-title: Acta Neurol Scand. doi: 10.1111/j.1600-0404.1998.tb00633.x – volume: 68 start-page: 1108 year: 2007 ident: 10.1016/j.clinthera.2009.10.018_bib6 article-title: Ropinirole 24-hour prolonged release: Randomized, controlled study in advanced Parkinson disease publication-title: Neurology. doi: 10.1212/01.wnl.0000258660.74391.c1 – volume: 39 start-page: 7 issue: Suppl 2 year: 1989 ident: 10.1016/j.clinthera.2009.10.018_bib20 article-title: Rationale for continuous dopaminomimetic therapy of Parkinson's disease publication-title: Neurology. – volume: 683 start-page: 209 year: 1996 ident: 10.1016/j.clinthera.2009.10.018_bib13 article-title: Determination of pramipexole (U-98,528) in human plasma by high-performance liquid chromatography with atmospheric pressure chemical ionization tandem mass spectrometry publication-title: J Chromatogr B Biomed Appl. doi: 10.1016/0378-4347(96)00124-7 – volume: 64 start-page: S56 issue: Suppl 2 year: 2008 ident: 10.1016/j.clinthera.2009.10.018_bib30 article-title: How do you treat motor complications in Parkinson's disease: Medicine, surgery, or both? publication-title: Ann Neurol. – volume: 20 start-page: 1502 year: 2005 ident: 10.1016/j.clinthera.2009.10.018_bib23 article-title: Suboptimal medication adherence in Parkinson's disease publication-title: Mov Disord. doi: 10.1002/mds.20602 – volume: 10 start-page: 37 year: 1995 ident: 10.1016/j.clinthera.2009.10.018_bib27 article-title: Apomorphine infusional therapy in Parkinson's disease: Clinical utility and lack of tolerance publication-title: Mov Disord. doi: 10.1002/mds.870100108 – volume: 4 start-page: 193 year: 2008 ident: 10.1016/j.clinthera.2009.10.018_bib32 article-title: Irregular gastrointestinal drug absorption in Parkinson's disease publication-title: Expert Opin Drug Metab Toxicol. doi: 10.1517/17425255.4.2.193 – volume: 7 start-page: 15 issue: Suppl 1 year: 2000 ident: 10.1016/j.clinthera.2009.10.018_bib10 article-title: Pre-clinical studies of pramipexole: Clinical relevance publication-title: Eur J Neurol. doi: 10.1046/j.1468-1331.2000.0070s1015.x – volume: 6 start-page: 1275 year: 2006 ident: 10.1016/j.clinthera.2009.10.018_bib5 article-title: Rotigotine for the treatment of Parkinson's disease publication-title: Expert Rev Neurother. doi: 10.1586/14737175.6.9.1275 – volume: 49 start-page: 162 year: 1997 ident: 10.1016/j.clinthera.2009.10.018_bib7 article-title: Clinical evaluation of pramipexole in advanced Parkinson's disease: Results of a double-blind, placebo-controlled, parallel-group study publication-title: Neurology. doi: 10.1212/WNL.49.1.162 – volume: 62 start-page: 905 year: 2005 ident: 10.1016/j.clinthera.2009.10.018_bib29 article-title: Intermittent vs continuous levodopa administration in patients with advanced Parkinson disease: A clinical and pharmacokinetic study publication-title: Arch Neurol. doi: 10.1001/archneur.62.6.905 – volume: 13 start-page: 1 issue: Suppl 7 year: 2008 ident: 10.1016/j.clinthera.2009.10.018_bib22 article-title: Managing Parkinson's disease with continuous dopaminergic stimulation publication-title: CNS Spectr. |
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