Safety, tolerability, and pharmacokinetics of a single ascending dose of baicalein chewable tablets in healthy subjects
The root of Scutellaria baicalensis Georgi has been used extensively in traditional Chinese medicine for the treatment of inflammation, fever, cough, dysentery, and hypertension. Baicalein is a flavonoid isolated from the root of Scutellaria baicalensis Georgi and is a novel neuroprotective agent un...
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| Published in | Journal of ethnopharmacology Vol. 156; no. NA; pp. 210 - 215 |
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| Main Authors | , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Ireland
Elsevier Ireland Ltd
28.10.2014
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| Subjects | |
| Online Access | Get full text |
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| Abstract | The root of Scutellaria baicalensis Georgi has been used extensively in traditional Chinese medicine for the treatment of inflammation, fever, cough, dysentery, and hypertension. Baicalein is a flavonoid isolated from the root of Scutellaria baicalensis Georgi and is a novel neuroprotective agent under development for the treatment of Parkinson׳s disease. We aimed to investigate the pharmacokinetic (PK) properties of baicalein and its main metabolite, bacalin, after single-dose administration in healthy Chinese subjects. The safety and tolerability of baicalein were also assessed.
This was a Phase I, randomized, double-blind, single-dose trial of baicalein (100–2800mg) in 72 healthy adults. Samples of blood, urine and feces were collected at regular intervals up to 48h after administration of the study drug. Baicalein and baicalin were then analyzed using liquid chromatography-tandem mass spectrometry (LC/MS/MS). The maximum concentration that the drug achieved after dosing (Cmax), time to Cmax (Tmax), terminal half-life (t1/2), area under the curve from time zero to time of last quantifiable concentration (AUC(0, t)), area under the curve from time zero to infinity (AUC(0, ∞)), apparent total plasma clearance (CL/F), and apparent total volume of distribution (V/F) were determined using non-compartmental models. Dose proportion was tested using a method combining the equivalence criterion and power model. Physical examinations, vital signs, ECG findings, hematology, and urinalysis were monitored before and at regular intervals after administration of the study drug.
The PK profile of baicelein and baicelin was characterized by a median Tmax of 0.75–3.5h and 0.5–3h, respectively, followed by a multiphasic profile with a t1/2 of 1.90–15.01h and 4.22–10.80h, respectively. The estimates of the proportionality coefficient (90% CI) for Cmax, AUC0–t and AUC0–∞ were 0.83 (0.70–0.96), 0.91 (0.81–1.00) and 0.92 (0.82–1.02), respectively. All values overlapped within the pre-specified range of (0.89–1.11), (0.93–1.07), and (0.93–1.07), respectively. Dose proportionality was inconclusive for a baicalein dose range of 100–2800mg. The total urinary clearance of baicalein and baicalin was <1%. Approximately 27% of baicalein was eliminated as unchanged drug in feces. Baicalein was well tolerated. Eleven treatment-related adverse events were observed, and all were rated as “mild” and resolved without further treatment. No serious adverse events occurred.
Single oral doses of 100–2800mg of baicalein were safe and well tolerated by healthy subjects. Clinical laboratory assessments showed no signs of toxicity in the liver or kidney. The favorable safety profile and PK properties warrant further clinical studies for baicalein.
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| AbstractList | The root of Scutellaria baicalensis Georgi has been used extensively in traditional Chinese medicine for the treatment of inflammation, fever, cough, dysentery, and hypertension. Baicalein is a flavonoid isolated from the root of Scutellaria baicalensis Georgi and is a novel neuroprotective agent under development for the treatment of Parkinson׳s disease. We aimed to investigate the pharmacokinetic (PK) properties of baicalein and its main metabolite, bacalin, after single-dose administration in healthy Chinese subjects. The safety and tolerability of baicalein were also assessed.ETHNOPHARMACOLOGICAL RELEVANCEThe root of Scutellaria baicalensis Georgi has been used extensively in traditional Chinese medicine for the treatment of inflammation, fever, cough, dysentery, and hypertension. Baicalein is a flavonoid isolated from the root of Scutellaria baicalensis Georgi and is a novel neuroprotective agent under development for the treatment of Parkinson׳s disease. We aimed to investigate the pharmacokinetic (PK) properties of baicalein and its main metabolite, bacalin, after single-dose administration in healthy Chinese subjects. The safety and tolerability of baicalein were also assessed.This was a Phase I, randomized, double-blind, single-dose trial of baicalein (100-2800 mg) in 72 healthy adults. Samples of blood, urine and feces were collected at regular intervals up to 48 h after administration of the study drug. Baicalein and baicalin were then analyzed using liquid chromatography-tandem mass spectrometry (LC/MS/MS). The maximum concentration that the drug achieved after dosing (Cmax), time to Cmax (Tmax), terminal half-life (t₁/₂), area under the curve from time zero to time of last quantifiable concentration (AUC(0, t)), area under the curve from time zero to infinity (AUC(0, ∞)), apparent total plasma clearance (CL/F), and apparent total volume of distribution (V/F) were determined using non-compartmental models. Dose proportion was tested using a method combining the equivalence criterion and power model. Physical examinations, vital signs, ECG findings, hematology, and urinalysis were monitored before and at regular intervals after administration of the study drug.MATERIALS AND METHODSThis was a Phase I, randomized, double-blind, single-dose trial of baicalein (100-2800 mg) in 72 healthy adults. Samples of blood, urine and feces were collected at regular intervals up to 48 h after administration of the study drug. Baicalein and baicalin were then analyzed using liquid chromatography-tandem mass spectrometry (LC/MS/MS). The maximum concentration that the drug achieved after dosing (Cmax), time to Cmax (Tmax), terminal half-life (t₁/₂), area under the curve from time zero to time of last quantifiable concentration (AUC(0, t)), area under the curve from time zero to infinity (AUC(0, ∞)), apparent total plasma clearance (CL/F), and apparent total volume of distribution (V/F) were determined using non-compartmental models. Dose proportion was tested using a method combining the equivalence criterion and power model. Physical examinations, vital signs, ECG findings, hematology, and urinalysis were monitored before and at regular intervals after administration of the study drug.The PK profile of baicelein and baicelin was characterized by a median Tmax of 0.75-3.5 h and 0.5-3 h, respectively, followed by a multiphasic profile with a t₁/₂ of 1.90-15.01 h and 4.22-10.80 h, respectively. The estimates of the proportionality coefficient (90% CI) for Cmax, AUC₀-t and AUC₀-∞ were 0.83 (0.70-0.96), 0.91 (0.81-1.00) and 0.92 (0.82-1.02), respectively. All values overlapped within the pre-specified range of (0.89-1.11), (0.93-1.07), and (0.93-1.07), respectively. Dose proportionality was inconclusive for a baicalein dose range of 100-2800 mg. The total urinary clearance of baicalein and baicalin was <1%. Approximately 27% of baicalein was eliminated as unchanged drug in feces. Baicalein was well tolerated. Eleven treatment-related adverse events were observed, and all were rated as "mild" and resolved without further treatment. No serious adverse events occurred.RESULTSThe PK profile of baicelein and baicelin was characterized by a median Tmax of 0.75-3.5 h and 0.5-3 h, respectively, followed by a multiphasic profile with a t₁/₂ of 1.90-15.01 h and 4.22-10.80 h, respectively. The estimates of the proportionality coefficient (90% CI) for Cmax, AUC₀-t and AUC₀-∞ were 0.83 (0.70-0.96), 0.91 (0.81-1.00) and 0.92 (0.82-1.02), respectively. All values overlapped within the pre-specified range of (0.89-1.11), (0.93-1.07), and (0.93-1.07), respectively. Dose proportionality was inconclusive for a baicalein dose range of 100-2800 mg. The total urinary clearance of baicalein and baicalin was <1%. Approximately 27% of baicalein was eliminated as unchanged drug in feces. Baicalein was well tolerated. Eleven treatment-related adverse events were observed, and all were rated as "mild" and resolved without further treatment. No serious adverse events occurred.Single oral doses of 100-2800 mg of baicalein were safe and well tolerated by healthy subjects. Clinical laboratory assessments showed no signs of toxicity in the liver or kidney. The favorable safety profile and PK properties warrant further clinical studies for baicalein.CONCLUSIONSSingle oral doses of 100-2800 mg of baicalein were safe and well tolerated by healthy subjects. Clinical laboratory assessments showed no signs of toxicity in the liver or kidney. The favorable safety profile and PK properties warrant further clinical studies for baicalein. The root of Scutellaria baicalensis Georgi has been used extensively in traditional Chinese medicine for the treatment of inflammation, fever, cough, dysentery, and hypertension. Baicalein is a flavonoid isolated from the root of Scutellaria baicalensis Georgi and is a novel neuroprotective agent under development for the treatment of Parkinson׳s disease. We aimed to investigate the pharmacokinetic (PK) properties of baicalein and its main metabolite, bacalin, after single-dose administration in healthy Chinese subjects. The safety and tolerability of baicalein were also assessed.This was a Phase I, randomized, double-blind, single-dose trial of baicalein (100–2800mg) in 72 healthy adults. Samples of blood, urine and feces were collected at regular intervals up to 48h after administration of the study drug. Baicalein and baicalin were then analyzed using liquid chromatography-tandem mass spectrometry (LC/MS/MS). The maximum concentration that the drug achieved after dosing (Cmax), time to Cmax (Tmax), terminal half-life (t1/2), area under the curve from time zero to time of last quantifiable concentration (AUC(0, t)), area under the curve from time zero to infinity (AUC(0, ∞)), apparent total plasma clearance (CL/F), and apparent total volume of distribution (V/F) were determined using non-compartmental models. Dose proportion was tested using a method combining the equivalence criterion and power model. Physical examinations, vital signs, ECG findings, hematology, and urinalysis were monitored before and at regular intervals after administration of the study drug.The PK profile of baicelein and baicelin was characterized by a median Tmax of 0.75–3.5h and 0.5–3h, respectively, followed by a multiphasic profile with a t1/2 of 1.90–15.01h and 4.22–10.80h, respectively. The estimates of the proportionality coefficient (90% CI) for Cmax, AUC0–t and AUC0–∞ were 0.83 (0.70–0.96), 0.91 (0.81–1.00) and 0.92 (0.82–1.02), respectively. All values overlapped within the pre-specified range of (0.89–1.11), (0.93–1.07), and (0.93–1.07), respectively. Dose proportionality was inconclusive for a baicalein dose range of 100–2800mg. The total urinary clearance of baicalein and baicalin was <1%. Approximately 27% of baicalein was eliminated as unchanged drug in feces. Baicalein was well tolerated. Eleven treatment-related adverse events were observed, and all were rated as “mild” and resolved without further treatment. No serious adverse events occurred.Single oral doses of 100–2800mg of baicalein were safe and well tolerated by healthy subjects. Clinical laboratory assessments showed no signs of toxicity in the liver or kidney. The favorable safety profile and PK properties warrant further clinical studies for baicalein. The root of Scutellaria baicalensis Georgi has been used extensively in traditional Chinese medicine for the treatment of inflammation, fever, cough, dysentery, and hypertension. Baicalein is a flavonoid isolated from the root of Scutellaria baicalensis Georgi and is a novel neuroprotective agent under development for the treatment of Parkinson׳s disease. We aimed to investigate the pharmacokinetic (PK) properties of baicalein and its main metabolite, bacalin, after single-dose administration in healthy Chinese subjects. The safety and tolerability of baicalein were also assessed. This was a Phase I, randomized, double-blind, single-dose trial of baicalein (100-2800 mg) in 72 healthy adults. Samples of blood, urine and feces were collected at regular intervals up to 48 h after administration of the study drug. Baicalein and baicalin were then analyzed using liquid chromatography-tandem mass spectrometry (LC/MS/MS). The maximum concentration that the drug achieved after dosing (Cmax), time to Cmax (Tmax), terminal half-life (t₁/₂), area under the curve from time zero to time of last quantifiable concentration (AUC(0, t)), area under the curve from time zero to infinity (AUC(0, ∞)), apparent total plasma clearance (CL/F), and apparent total volume of distribution (V/F) were determined using non-compartmental models. Dose proportion was tested using a method combining the equivalence criterion and power model. Physical examinations, vital signs, ECG findings, hematology, and urinalysis were monitored before and at regular intervals after administration of the study drug. The PK profile of baicelein and baicelin was characterized by a median Tmax of 0.75-3.5 h and 0.5-3 h, respectively, followed by a multiphasic profile with a t₁/₂ of 1.90-15.01 h and 4.22-10.80 h, respectively. The estimates of the proportionality coefficient (90% CI) for Cmax, AUC₀-t and AUC₀-∞ were 0.83 (0.70-0.96), 0.91 (0.81-1.00) and 0.92 (0.82-1.02), respectively. All values overlapped within the pre-specified range of (0.89-1.11), (0.93-1.07), and (0.93-1.07), respectively. Dose proportionality was inconclusive for a baicalein dose range of 100-2800 mg. The total urinary clearance of baicalein and baicalin was <1%. Approximately 27% of baicalein was eliminated as unchanged drug in feces. Baicalein was well tolerated. Eleven treatment-related adverse events were observed, and all were rated as "mild" and resolved without further treatment. No serious adverse events occurred. Single oral doses of 100-2800 mg of baicalein were safe and well tolerated by healthy subjects. Clinical laboratory assessments showed no signs of toxicity in the liver or kidney. The favorable safety profile and PK properties warrant further clinical studies for baicalein. The root of Scutellaria baicalensis Georgi has been used extensively in traditional Chinese medicine for the treatment of inflammation, fever, cough, dysentery, and hypertension. Baicalein is a flavonoid isolated from the root of Scutellaria baicalensis Georgi and is a novel neuroprotective agent under development for the treatment of Parkinson׳s disease. We aimed to investigate the pharmacokinetic (PK) properties of baicalein and its main metabolite, bacalin, after single-dose administration in healthy Chinese subjects. The safety and tolerability of baicalein were also assessed. This was a Phase I, randomized, double-blind, single-dose trial of baicalein (100–2800mg) in 72 healthy adults. Samples of blood, urine and feces were collected at regular intervals up to 48h after administration of the study drug. Baicalein and baicalin were then analyzed using liquid chromatography-tandem mass spectrometry (LC/MS/MS). The maximum concentration that the drug achieved after dosing (Cmax), time to Cmax (Tmax), terminal half-life (t1/2), area under the curve from time zero to time of last quantifiable concentration (AUC(0, t)), area under the curve from time zero to infinity (AUC(0, ∞)), apparent total plasma clearance (CL/F), and apparent total volume of distribution (V/F) were determined using non-compartmental models. Dose proportion was tested using a method combining the equivalence criterion and power model. Physical examinations, vital signs, ECG findings, hematology, and urinalysis were monitored before and at regular intervals after administration of the study drug. The PK profile of baicelein and baicelin was characterized by a median Tmax of 0.75–3.5h and 0.5–3h, respectively, followed by a multiphasic profile with a t1/2 of 1.90–15.01h and 4.22–10.80h, respectively. The estimates of the proportionality coefficient (90% CI) for Cmax, AUC0–t and AUC0–∞ were 0.83 (0.70–0.96), 0.91 (0.81–1.00) and 0.92 (0.82–1.02), respectively. All values overlapped within the pre-specified range of (0.89–1.11), (0.93–1.07), and (0.93–1.07), respectively. Dose proportionality was inconclusive for a baicalein dose range of 100–2800mg. The total urinary clearance of baicalein and baicalin was <1%. Approximately 27% of baicalein was eliminated as unchanged drug in feces. Baicalein was well tolerated. Eleven treatment-related adverse events were observed, and all were rated as “mild” and resolved without further treatment. No serious adverse events occurred. Single oral doses of 100–2800mg of baicalein were safe and well tolerated by healthy subjects. Clinical laboratory assessments showed no signs of toxicity in the liver or kidney. The favorable safety profile and PK properties warrant further clinical studies for baicalein. [Display omitted] |
| Author | He, Guorong Li, Min Shi, Aixin Pang, Hongxian Dong, Fan Xue, Wei Xiao, Wei Du, Guanhua Li, Kexin Cao, Guoying Yan, Bei Li, Yang Hu, Xin |
| Author_xml | – sequence: 1 givenname: Min surname: Li fullname: Li, Min organization: Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation, Department of Clinical pharmacology, Beijing Hospital of the Ministry of Health, Beijing 100730, China – sequence: 2 givenname: Aixin surname: Shi fullname: Shi, Aixin email: aixins0302@126.com organization: Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation, Department of Clinical pharmacology, Beijing Hospital of the Ministry of Health, Beijing 100730, China – sequence: 3 givenname: Hongxian surname: Pang fullname: Pang, Hongxian organization: Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation, Department of Clinical pharmacology, Beijing Hospital of the Ministry of Health, Beijing 100730, China – sequence: 4 givenname: Wei surname: Xue fullname: Xue, Wei organization: Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation, Department of Clinical pharmacology, Beijing Hospital of the Ministry of Health, Beijing 100730, China – sequence: 5 givenname: Yang surname: Li fullname: Li, Yang organization: Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation, Department of Clinical pharmacology, Beijing Hospital of the Ministry of Health, Beijing 100730, China – sequence: 6 givenname: Guoying surname: Cao fullname: Cao, Guoying organization: Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation, Department of Clinical pharmacology, Beijing Hospital of the Ministry of Health, Beijing 100730, China – sequence: 7 givenname: Bei surname: Yan fullname: Yan, Bei organization: Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation, Department of Clinical pharmacology, Beijing Hospital of the Ministry of Health, Beijing 100730, China – sequence: 8 givenname: Fan surname: Dong fullname: Dong, Fan organization: Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation, Department of Clinical pharmacology, Beijing Hospital of the Ministry of Health, Beijing 100730, China – sequence: 9 givenname: Kexin surname: Li fullname: Li, Kexin organization: Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation, Department of Clinical pharmacology, Beijing Hospital of the Ministry of Health, Beijing 100730, China – sequence: 10 givenname: Wei surname: Xiao fullname: Xiao, Wei organization: StateKey Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, JiangsuKanion Parmaceutical CO. LTD., Lianyungang, Jiangsu 222001, China – sequence: 11 givenname: Guorong surname: He fullname: He, Guorong organization: Beijing Key Laboratory of Drug Targets Identification and Drug Screening, Institute of Materia Medica, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100050, China – sequence: 12 givenname: Guanhua surname: Du fullname: Du, Guanhua organization: Beijing Key Laboratory of Drug Targets Identification and Drug Screening, Institute of Materia Medica, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100050, China – sequence: 13 givenname: Xin surname: Hu fullname: Hu, Xin organization: Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation, Department of Clinical pharmacology, Beijing Hospital of the Ministry of Health, Beijing 100730, China |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/25219601$$D View this record in MEDLINE/PubMed |
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| Title | Safety, tolerability, and pharmacokinetics of a single ascending dose of baicalein chewable tablets in healthy subjects |
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