Pharmacokinetics and Bioequivalence Studies of Galantamine Hydrobromide Dispersible Tablet in Healthy Male Chinese Volunteers
ABSTRACT A randomized, two-way, crossover study was conducted in 18 healthy male Chinese volunteers to compare pharmacokinetics profiles of galantamine hydrobromide dispersible tablet with that of conventional tablet. A single oral dose of 10 mg galantamine was administrated to each volunteer. Plasm...
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| Published in | Drug development and industrial pharmacy Vol. 33; no. 3; pp. 335 - 340 |
|---|---|
| Main Authors | , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Colchester
Informa UK Ltd
01.03.2007
Taylor & Francis |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0363-9045 1520-5762 |
| DOI | 10.1080/03639040600868011 |
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| Abstract | ABSTRACT
A randomized, two-way, crossover study was conducted in 18 healthy male Chinese volunteers to compare pharmacokinetics profiles of galantamine hydrobromide dispersible tablet with that of conventional tablet. A single oral dose of 10 mg galantamine was administrated to each volunteer. Plasma concentrations of galantamine were determined by a validated high-performance liquid chromatography (HPLC) method with fluorescence detection, which allowed 1 ng mL to be assayed as the lowest quantifiable concentration. From plasma concentrations, AUC0→t (the area under the plasma concentration-time curve from time 0 to the last sampling time, 32 hr), AUC0→∞ (the area under the plasma concentration-time curve from time 0 to infinity), t½ (elimination of half-life of the terminal log linear phase), Cmax (maximum plasma drug concentration) and Tmax (time to reach Cmax) were evaluated through noncompartmental pharmacokinetic analysis. AUC0→t and AUC0→∞ were calculated by the linear-log trapezoidal rule method. Cmax and Tmax were obtained directly from the plasma concentration-time curve. Analysis of variance was carried out using logarithmically transformed AUC0→t, AUC0→∞ and Cmax. As far as AUC0→t, AUC0→∞ and Cmax were concerned, there was no statistically significant difference between the test and reference formulations. Ninety percent confidence intervals (90% CI) for the ratio of AUC0→t, AUC0→∞ and Cmax values for the test and reference formulations were 100.4-107.8%, 99.0-107.2% and 87.5-111.3%, respectively. As the 90% CIs of AUC0→t, AUC0→∞ and Cmax were entirely within 80-125%, two formulations were considered bioequivalent. |
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| AbstractList | A randomized, two-way, crossover study was conducted in 18 healthy male Chinese volunteers to compare pharmacokinetics profiles of galantamine hydrobromide dispersible tablet with that of conventional tablet. A single oral dose of 10 mg galantamine was administrated to each volunteer. Plasma concentrations of galantamine were determined by a validated high-performance liquid chromatography (HPLC) method with fluorescence detection, which allowed 1 ng/mL to be assayed as the lowest quantifiable concentration. From plasma concentrations, AUC(0-->t) (the area under the plasma concentration-time curve from time 0 to the last sampling time, 32 hr), AUC(0-->infinity) (the area under the plasma concentration-time curve from time 0 to infinity), t((1/2)) (elimination of half-life of the terminal log linear phase), C(max) (maximum plasma drug concentration) and T(max) (time to reach C(max)) were evaluated through noncompartmental pharmacokinetic analysis. AUC(0-->t) and AUC(0-->infinity) were calculated by the linear-log trapezoidal rule method. C(max) and T(max) were obtained directly from the plasma concentration-time curve. Analysis of variance was carried out using logarithmically transformed AUC(0-->t), AUC(0-->infinity) and C(max). As far as AUC(0-->t), AUC(0-->infinity) and C(max) were concerned, there was no statistically significant difference between the test and reference formulations. Ninety percent confidence intervals (90% CI) for the ratio of AUC(0-->t), AUC(0-->infinity) and C(max) values for the test and reference formulations were 100.4-107.8%, 99.0-107.2% and 87.5-111.3%, respectively. As the 90% CIs of AUC(0-->t), AUC(0-->infinity) and C(max) were entirely within 80-125%, two formulations were considered bioequivalent. ABSTRACT A randomized, two-way, crossover study was conducted in 18 healthy male Chinese volunteers to compare pharmacokinetics profiles of galantamine hydrobromide dispersible tablet with that of conventional tablet. A single oral dose of 10 mg galantamine was administrated to each volunteer. Plasma concentrations of galantamine were determined by a validated high-performance liquid chromatography (HPLC) method with fluorescence detection, which allowed 1 ng mL to be assayed as the lowest quantifiable concentration. From plasma concentrations, AUC0→t (the area under the plasma concentration-time curve from time 0 to the last sampling time, 32 hr), AUC0→∞ (the area under the plasma concentration-time curve from time 0 to infinity), t½ (elimination of half-life of the terminal log linear phase), Cmax (maximum plasma drug concentration) and Tmax (time to reach Cmax) were evaluated through noncompartmental pharmacokinetic analysis. AUC0→t and AUC0→∞ were calculated by the linear-log trapezoidal rule method. Cmax and Tmax were obtained directly from the plasma concentration-time curve. Analysis of variance was carried out using logarithmically transformed AUC0→t, AUC0→∞ and Cmax. As far as AUC0→t, AUC0→∞ and Cmax were concerned, there was no statistically significant difference between the test and reference formulations. Ninety percent confidence intervals (90% CI) for the ratio of AUC0→t, AUC0→∞ and Cmax values for the test and reference formulations were 100.4-107.8%, 99.0-107.2% and 87.5-111.3%, respectively. As the 90% CIs of AUC0→t, AUC0→∞ and Cmax were entirely within 80-125%, two formulations were considered bioequivalent. A randomized, two-way, crossover study was conducted in 18 healthy male Chinese volunteers to compare pharmacokinetics profiles of galantamine hydrobromide dispersible tablet with that of conventional tablet. A single oral dose of 10 mg galantamine was administrated to each volunteer. Plasma concentrations of galantamine were determined by a validated high-performance liquid chromatography (HPLC) method with fluorescence detection, which allowed 1 ng/mL to be assayed as the lowest quantifiable concentration. From plasma concentrations, AUC 0→t (the area under the plasma concentration-time curve from time 0 to the last sampling time, 32 hr), AUC 0→∞ (the area under the plasma concentration-time curve from time 0 to infinity), t ½ (elimination of half-life of the terminal log linear phase), C max (maximum plasma drug concentration) and T max (time to reach C max ) were evaluated through noncompartmental pharmacokinetic analysis. AUC 0→t and AUC 0→∞ were calculated by the linear-log trapezoidal rule method. C max and T max were obtained directly from the plasma concentration-time curve. Analysis of variance was carried out using logarithmically transformed AUC 0→t , AUC 0→∞ and C max . As far as AUC 0→t , AUC 0→∞ and C max were concerned, there was no statistically significant difference between the test and reference formulations. Ninety percent confidence intervals (90% CI) for the ratio of AUC 0→t , AUC 0→∞ and C max values for the test and reference formulations were 100.4-107.8%, 99.0-107.2% and 87.5-111.3%, respectively. As the 90% CIs of AUC 0→t , AUC 0→∞ and C max were entirely within 80-125%, two formulations were considered bioequivalent. A randomized, two-way, crossover study was conducted in 18 healthy male Chinese volunteers to compare pharmacokinetics profiles of galantamine hydrobromide dispersible tablet with that of conventional tablet. A single oral dose of 10 mg galantamine was administrated to each volunteer. Plasma concentrations of galantamine were determined by a validated high-performance liquid chromatography (HPLC) method with fluorescence detection, which allowed 1 ng/mL to be assayed as the lowest quantifiable concentration. From plasma concentrations, AUC(0-->t) (the area under the plasma concentration-time curve from time 0 to the last sampling time, 32 hr), AUC(0-->infinity) (the area under the plasma concentration-time curve from time 0 to infinity), t((1/2)) (elimination of half-life of the terminal log linear phase), C(max) (maximum plasma drug concentration) and T(max) (time to reach C(max)) were evaluated through noncompartmental pharmacokinetic analysis. AUC(0-->t) and AUC(0-->infinity) were calculated by the linear-log trapezoidal rule method. C(max) and T(max) were obtained directly from the plasma concentration-time curve. Analysis of variance was carried out using logarithmically transformed AUC(0-->t), AUC(0-->infinity) and C(max). As far as AUC(0-->t), AUC(0-->infinity) and C(max) were concerned, there was no statistically significant difference between the test and reference formulations. Ninety percent confidence intervals (90% CI) for the ratio of AUC(0-->t), AUC(0-->infinity) and C(max) values for the test and reference formulations were 100.4-107.8%, 99.0-107.2% and 87.5-111.3%, respectively. As the 90% CIs of AUC(0-->t), AUC(0-->infinity) and C(max) were entirely within 80-125%, two formulations were considered bioequivalent.A randomized, two-way, crossover study was conducted in 18 healthy male Chinese volunteers to compare pharmacokinetics profiles of galantamine hydrobromide dispersible tablet with that of conventional tablet. A single oral dose of 10 mg galantamine was administrated to each volunteer. Plasma concentrations of galantamine were determined by a validated high-performance liquid chromatography (HPLC) method with fluorescence detection, which allowed 1 ng/mL to be assayed as the lowest quantifiable concentration. From plasma concentrations, AUC(0-->t) (the area under the plasma concentration-time curve from time 0 to the last sampling time, 32 hr), AUC(0-->infinity) (the area under the plasma concentration-time curve from time 0 to infinity), t((1/2)) (elimination of half-life of the terminal log linear phase), C(max) (maximum plasma drug concentration) and T(max) (time to reach C(max)) were evaluated through noncompartmental pharmacokinetic analysis. AUC(0-->t) and AUC(0-->infinity) were calculated by the linear-log trapezoidal rule method. C(max) and T(max) were obtained directly from the plasma concentration-time curve. Analysis of variance was carried out using logarithmically transformed AUC(0-->t), AUC(0-->infinity) and C(max). As far as AUC(0-->t), AUC(0-->infinity) and C(max) were concerned, there was no statistically significant difference between the test and reference formulations. Ninety percent confidence intervals (90% CI) for the ratio of AUC(0-->t), AUC(0-->infinity) and C(max) values for the test and reference formulations were 100.4-107.8%, 99.0-107.2% and 87.5-111.3%, respectively. As the 90% CIs of AUC(0-->t), AUC(0-->infinity) and C(max) were entirely within 80-125%, two formulations were considered bioequivalent. |
| Author | Zhang, Li-jun Li, Xue-ning Sha, Xian-yi Wang, Qing-song Fang, Xiao-ling Han, Li-mei Zhang, Zhi-wen |
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| Keywords | Human Pharmaceutical technology Bioequivalence Galantamine Healthy subject Enzyme Benzazepine derivatives Enzyme inhibitor HPLC chromatography Esterases Antialzheimer agent Acetylcholinesterase High-performance liquid chromatography Carboxylic ester hydrolases Parasympathomimetic Alkaloid Dosage form Hydrolases Tablet Anticholinesterase agent Pharmacokinetics |
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A randomized, two-way, crossover study was conducted in 18 healthy male Chinese volunteers to compare pharmacokinetics profiles of galantamine... A randomized, two-way, crossover study was conducted in 18 healthy male Chinese volunteers to compare pharmacokinetics profiles of galantamine hydrobromide... |
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| SubjectTerms | Adult Area Under Curve Bioequivalence Biological and medical sciences China Cholinesterase Inhibitors - blood Cholinesterase Inhibitors - pharmacokinetics Chromatography, High Pressure Liquid Cross-Over Studies Galantamine Galantamine - blood Galantamine - pharmacokinetics General pharmacology High-performance liquid chromatography Humans Male Medical sciences Pharmaceutical technology. Pharmaceutical industry Pharmacokinetics Pharmacology. Drug treatments Tablets Therapeutic Equivalency |
| Title | Pharmacokinetics and Bioequivalence Studies of Galantamine Hydrobromide Dispersible Tablet in Healthy Male Chinese Volunteers |
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