2003•Zhongguo linchuang yaolixue yu zhiliaoxueRequires access

Pharmacokinetics and relative bioavailability of metformin tablet in Ch inese healthy male volunteers

Zhao Hua

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Abstract

AIM: To study the pharmacokinetics and relative bioavailabli ty of metformin tablets in Chinese healthy male volunteers. METHODS: Eighteen male healthy volunteers received 1 000 mg metformin tablet orally a ccording to a crossover design. Drug concentrations in plasma were determined by high performance liquid chromatography with cation-exchange technique. RESULTS: The pharmacokinetic parameters of tested and reference tablet s were as follows: T 1/2 2.9 ± 0.2 and 3.0 ± 0. 5 h, C max 1.8 ± 0.5 and 1.7 ± 0.3 mg·L -1 , T max 1.6 ± 0.7 and 2.4 ± 0.8 h, and AUC 0~12 8.6 ± 1.9 and 8.6 ± 2.0 mg·h -1 ·L -1 . T he relative bioavailability of metformin tablets was 102±14%. CONCLUSIO N: The tested and reference preparations of metformin show bioequivalenc e.

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What this paper is about

AIM: To study the pharmacokinetics and relative bioavailabli ty of metformin tablets in Chinese healthy male volunteers. METHODS: Eighteen male healthy volunteers received 1 000 mg metformin tablet orally a ccording to a crossover design. Drug concentrations in plasma were determined by high performance liquid chromatography with cation-exchange technique. RESULTS: The pharmacokinetic parameters of tested and reference tablet s were as follows: T 1/2 2.9 ± 0.2 and 3.0 ± 0. 5 h, C max 1.8 ± 0.5 and 1.7 ± 0.3 mg·L -1 , T max 1.6 ± 0.7 and 2.4 ± 0.8 h, and AUC 0~12 8.6 ± 1.9 and 8.6 ± 2.0 mg·h -1 ·L -1 . T he relative bioavailability of metformin tablets was 102±14%. CONCLUSIO N: The tested and reference preparations of metformin show bioequivalenc e.

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Available abstract

AIM: To study the pharmacokinetics and relative bioavailabli ty of metformin tablets in Chinese healthy male volunteers. METHODS: Eighteen male healthy volunteers received 1 000 mg metformin tablet orally a ccording to a crossover design. Drug concentrations in plasma were determined by high performance liquid chromatography with cation-exchange technique. RESULTS: The pharmacokinetic parameters of tested and reference tablet s were as follows: T 1/2 2.9 ± 0.2 and 3.0 ± 0. 5 h, C max 1.8 ± 0.5 and 1.7 ± 0.3 mg·L -1 , T max 1.6 ± 0.7 and 2.4 ± 0.8 h, and AUC 0~12 8.6 ± 1.9 and 8.6 ± 2.0 mg·h -1 ·L -1 . T he relative bioavailability of metformin tablets was 102±14%. CONCLUSIO N: The tested and reference preparations of metformin show bioequivalenc e.

Key concepts: Pharmacokinetics, Bioavailability, Metformin, Crossover study, Pharmacology, Bioequivalence, Medicine, Plasma concentration

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