Comparison of the effects of fasting morning, fasting evening and fed bedtime administration of tenatoprazole on intragastric pH in healthy volunteers: a randomized three‐way crossover study
Background The effectiveness of proton pump inhibitors is influenced by meals and administration time. Aim To compare the effects on intragastric acidity of times of dosing of tenatoprazole, a novel imidazopyridine‐based proton pump inhibitor with a prolonged plasma half‐life. Methods This random...
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| Published in | Alimentary pharmacology & therapeutics Vol. 23; no. 8; pp. 1179 - 1187 |
|---|---|
| Main Authors | , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Oxford, UK
Blackwell Publishing Ltd
01.04.2006
Blackwell |
| Subjects | |
| Online Access | Get full text |
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| Abstract | Background The effectiveness of proton pump inhibitors is influenced by meals and administration time.
Aim To compare the effects on intragastric acidity of times of dosing of tenatoprazole, a novel imidazopyridine‐based proton pump inhibitor with a prolonged plasma half‐life.
Methods This randomized three‐period crossover study included 12 Helicobacter pylori‐negative healthy subjects, who received tenatoprazole 40 mg either fasting at 7.00 am, fasting at 7.00 pm or fed at 9.30 pm for 7 days, with a 2‐week washout between periods. Twenty‐four hour intragastric pH was monitored on day 7 of each period.
Results On day 7, median 24‐h pH was 4.7, 5.1 and 4.7 after breakfast, dinner and bedtime dosing, respectively (P = 0.11), whereas night‐time pH was 4.2, 5.0 and 4.4 (P = 0.13). The mean 24‐h percentage of time over pH 4 was 62, 72 and 64 after breakfast, dinner and bedtime dosing, respectively (N.S.), and 54, 68 and 56 during night‐time (P = 0.06). Nocturnal acid breakthrough incidence decreased from 100% at baseline to 83%, 55% and 75% after 7.00 am, 7.00 pm and 9.30 pm dosing, respectively (P = 0.18), and its mean duration dropped from 6.2 to 2.8, 1.0 and 2.2 h, respectively (P < 0.05).
Conclusion Seven‐day administration of tenatoprazole provides a prolonged duration of acid suppression, especially during the night‐time, with little effect of food or time of dosing. |
|---|---|
| AbstractList | Background
The effectiveness of proton pump inhibitors is influenced by meals and administration time.
Aim
To compare the effects on intragastric acidity of times of dosing of tenatoprazole, a novel imidazopyridine‐based proton pump inhibitor with a prolonged plasma half‐life.
Methods
This randomized three‐period crossover study included 12
Helicobacter pylori
‐negative healthy subjects, who received tenatoprazole 40 mg either fasting at 7.00
am
, fasting at 7.00
pm
or fed at 9.30
pm
for 7 days, with a 2‐week washout between periods. Twenty‐four hour intragastric pH was monitored on day 7 of each period.
Results
On day 7, median 24‐h pH was 4.7, 5.1 and 4.7 after breakfast, dinner and bedtime dosing, respectively (
P
= 0.11), whereas night‐time pH was 4.2, 5.0 and 4.4 (
P
= 0.13). The mean 24‐h percentage of time over pH 4 was 62, 72 and 64 after breakfast, dinner and bedtime dosing, respectively (N.S.), and 54, 68 and 56 during night‐time (
P
= 0.06). Nocturnal acid breakthrough incidence decreased from 100% at baseline to 83%, 55% and 75% after 7.00
am
, 7.00
pm
and 9.30
pm
dosing, respectively (
P
= 0.18), and its mean duration dropped from 6.2 to 2.8, 1.0 and 2.2 h, respectively (
P
< 0.05).
Conclusion
Seven‐day administration of tenatoprazole provides a prolonged duration of acid suppression, especially during the night‐time, with little effect of food or time of dosing. Background: The effectiveness of proton pump inhibitors is influenced by meals and administration time. Aim: To compare the effects on intragastric acidity of times of dosing of tenatoprazole, a novel imidazopyridine-based proton pump inhibitor with a prolonged plasma half-life. Methods: This randomized three-period crossover study included 12 Helicobacter pylori-negative healthy subjects, who received tenatoprazole 40 mg either fasting at 7.00 am, fasting at 7.00 pm or fed at 9.30 pm for 7 days, with a 2-week washout between periods. Twenty-four hour intragastric pH was monitored on day 7 of each period. Results: On day 7, median 24-h pH was 4.7, 5.1 and 4.7 after breakfast, dinner and bedtime dosing, respectively (P = 0.11), whereas night-time pH was 4.2, 5.0 and 4.4 (P = 0.13). The mean 24-h percentage of time over pH 4 was 62, 72 and 64 after breakfast, dinner and bedtime dosing, respectively (N.S.), and 54, 68 and 56 during night-time (P = 0.06). Nocturnal acid breakthrough incidence decreased from 100% at baseline to 83%, 55% and 75% after 7.00 am, 7.00 pm and 9.30 pm dosing, respectively (P = 0.18), and its mean duration dropped from 6.2 to 2.8, 1.0 and 2.2 h, respectively (P < 0.05). Conclusion: Seven-day administration of tenatoprazole provides a prolonged duration of acid suppression, especially during the night-time, with little effect of food or time of dosing. The effectiveness of proton pump inhibitors is influenced by meals and administration time. To compare the effects on intragastric acidity of times of dosing of tenatoprazole, a novel imidazopyridine-based proton pump inhibitor with a prolonged plasma half-life. This randomized three-period crossover study included 12 Helicobacter pylori-negative healthy subjects, who received tenatoprazole 40 mg either fasting at 7.00 AM, fasting at 7.00 PM or fed at 9.30 PM for 7 days, with a 2-week washout between periods. Twenty-four hour intragastric pH was monitored on day 7 of each period. On day 7, median 24-h pH was 4.7, 5.1 and 4.7 after breakfast, dinner and bedtime dosing, respectively (P = 0.11), whereas night-time pH was 4.2, 5.0 and 4.4 (P = 0.13). The mean 24-h percentage of time over pH 4 was 62, 72 and 64 after breakfast, dinner and bedtime dosing, respectively (N.S.), and 54, 68 and 56 during night-time (P = 0.06). Nocturnal acid breakthrough incidence decreased from 100% at baseline to 83%, 55% and 75% after 7.00 AM, 7.00 PM and 9.30 PM dosing, respectively (P = 0.18), and its mean duration dropped from 6.2 to 2.8, 1.0 and 2.2 h, respectively (P < 0.05). Seven-day administration of tenatoprazole provides a prolonged duration of acid suppression, especially during the night-time, with little effect of food or time of dosing. The effectiveness of proton pump inhibitors is influenced by meals and administration time.BACKGROUNDThe effectiveness of proton pump inhibitors is influenced by meals and administration time.To compare the effects on intragastric acidity of times of dosing of tenatoprazole, a novel imidazopyridine-based proton pump inhibitor with a prolonged plasma half-life.AIMTo compare the effects on intragastric acidity of times of dosing of tenatoprazole, a novel imidazopyridine-based proton pump inhibitor with a prolonged plasma half-life.This randomized three-period crossover study included 12 Helicobacter pylori-negative healthy subjects, who received tenatoprazole 40 mg either fasting at 7.00 AM, fasting at 7.00 PM or fed at 9.30 PM for 7 days, with a 2-week washout between periods. Twenty-four hour intragastric pH was monitored on day 7 of each period.METHODSThis randomized three-period crossover study included 12 Helicobacter pylori-negative healthy subjects, who received tenatoprazole 40 mg either fasting at 7.00 AM, fasting at 7.00 PM or fed at 9.30 PM for 7 days, with a 2-week washout between periods. Twenty-four hour intragastric pH was monitored on day 7 of each period.On day 7, median 24-h pH was 4.7, 5.1 and 4.7 after breakfast, dinner and bedtime dosing, respectively (P = 0.11), whereas night-time pH was 4.2, 5.0 and 4.4 (P = 0.13). The mean 24-h percentage of time over pH 4 was 62, 72 and 64 after breakfast, dinner and bedtime dosing, respectively (N.S.), and 54, 68 and 56 during night-time (P = 0.06). Nocturnal acid breakthrough incidence decreased from 100% at baseline to 83%, 55% and 75% after 7.00 AM, 7.00 PM and 9.30 PM dosing, respectively (P = 0.18), and its mean duration dropped from 6.2 to 2.8, 1.0 and 2.2 h, respectively (P < 0.05).RESULTSOn day 7, median 24-h pH was 4.7, 5.1 and 4.7 after breakfast, dinner and bedtime dosing, respectively (P = 0.11), whereas night-time pH was 4.2, 5.0 and 4.4 (P = 0.13). The mean 24-h percentage of time over pH 4 was 62, 72 and 64 after breakfast, dinner and bedtime dosing, respectively (N.S.), and 54, 68 and 56 during night-time (P = 0.06). Nocturnal acid breakthrough incidence decreased from 100% at baseline to 83%, 55% and 75% after 7.00 AM, 7.00 PM and 9.30 PM dosing, respectively (P = 0.18), and its mean duration dropped from 6.2 to 2.8, 1.0 and 2.2 h, respectively (P < 0.05).Seven-day administration of tenatoprazole provides a prolonged duration of acid suppression, especially during the night-time, with little effect of food or time of dosing.CONCLUSIONSeven-day administration of tenatoprazole provides a prolonged duration of acid suppression, especially during the night-time, with little effect of food or time of dosing. Background The effectiveness of proton pump inhibitors is influenced by meals and administration time. Aim To compare the effects on intragastric acidity of times of dosing of tenatoprazole, a novel imidazopyridine‐based proton pump inhibitor with a prolonged plasma half‐life. Methods This randomized three‐period crossover study included 12 Helicobacter pylori‐negative healthy subjects, who received tenatoprazole 40 mg either fasting at 7.00 am, fasting at 7.00 pm or fed at 9.30 pm for 7 days, with a 2‐week washout between periods. Twenty‐four hour intragastric pH was monitored on day 7 of each period. Results On day 7, median 24‐h pH was 4.7, 5.1 and 4.7 after breakfast, dinner and bedtime dosing, respectively (P = 0.11), whereas night‐time pH was 4.2, 5.0 and 4.4 (P = 0.13). The mean 24‐h percentage of time over pH 4 was 62, 72 and 64 after breakfast, dinner and bedtime dosing, respectively (N.S.), and 54, 68 and 56 during night‐time (P = 0.06). Nocturnal acid breakthrough incidence decreased from 100% at baseline to 83%, 55% and 75% after 7.00 am, 7.00 pm and 9.30 pm dosing, respectively (P = 0.18), and its mean duration dropped from 6.2 to 2.8, 1.0 and 2.2 h, respectively (P < 0.05). Conclusion Seven‐day administration of tenatoprazole provides a prolonged duration of acid suppression, especially during the night‐time, with little effect of food or time of dosing. |
| Author | DOMAGALA, F. COHEN, P. THOMSON, A. B. R. FICHEUX, H. FIORENTINI, P. HOMERIN, M. TACCOEN, A. |
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| Keywords | Human Randomization Fasting Healthy subject pH Antiulcer agent Tenatoprazole Gastrointestinal Crossover study Comparative study Feeding |
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| Snippet | Background The effectiveness of proton pump inhibitors is influenced by meals and administration time.
Aim To compare the effects on intragastric acidity of... Background The effectiveness of proton pump inhibitors is influenced by meals and administration time. Aim To compare the effects on intragastric acidity of... The effectiveness of proton pump inhibitors is influenced by meals and administration time. To compare the effects on intragastric acidity of times of dosing... Background: The effectiveness of proton pump inhibitors is influenced by meals and administration time. Aim: To compare the effects on intragastric acidity of... The effectiveness of proton pump inhibitors is influenced by meals and administration time.BACKGROUNDThe effectiveness of proton pump inhibitors is influenced... |
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| SubjectTerms | 2-Pyridinylmethylsulfinylbenzimidazoles Adolescent Adult Analysis of Variance Anti-Ulcer Agents - blood Anti-Ulcer Agents - pharmacokinetics Anti-Ulcer Agents - pharmacology Biological and medical sciences Circadian Rhythm Cross-Over Studies Digestive system Drug Administration Schedule Eating Fasting Gastric Acidity Determination Gastric Juice - metabolism Gastroenterology. Liver. Pancreas. Abdomen Helicobacter Humans Hydrogen-Ion Concentration Imidazoles - blood Imidazoles - pharmacokinetics Imidazoles - pharmacology Male Medical sciences Omeprazole - analogs & derivatives Omeprazole - blood Omeprazole - pharmacokinetics Omeprazole - pharmacology Pharmacology. Drug treatments Pyridines - blood Pyridines - pharmacokinetics Pyridines - pharmacology Statistics, Nonparametric |
| Title | Comparison of the effects of fasting morning, fasting evening and fed bedtime administration of tenatoprazole on intragastric pH in healthy volunteers: a randomized three‐way crossover study |
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