Please use this identifier to cite or link to this item: http://repositorio.unicamp.br/jspui/handle/REPOSIP/56316
Type: Artigo de periódico
Title: Comparison study of two glimepiride formulations bioavailability in healthy volunteers of both sexes after a single dose administration
Author: Do Carmo Borges, NC
Taveira, YD
Mazucheli, JA
Haddad, AL
Astigarraga, REB
Moreno, RA
Abstract: Objective: To compare the bioavailability of two glimepiride 4-mg tablet formulation in 26 healthy volunteers of both sexes. Material and methods: The study was conducted open with randomized two-period crossover design and a 14-day washout period. Samples were obtained over a 48-hour interval. Glimepiride concentrations were analyzed by LC-MS-MS. From the glimepiride plasma concentration versus time curves the following pharmacokinetic parameters were obtained: AUC((0-last)), AUC((0-t)), AUC((0-infinity)), K-e, T-1/2, C-max, and T-max, Results: Geometric mean of Glimepirida/Amaryl (R) 4 mg was 102.35% for AUC((0-t)), 102.35% for AUC((0-infinity)) and 99.31% for C-max. The 90% Cl was 92.62-109.55%; 95.62-109.55% e 88.60-111.32%, respectively. Conclusion: Since the 90% Cl for both C-max AUC((0-t)), and AUC((0-infinity)) were within the interval of 80-125%, it was concluded that both formulations were bioequivalent, according to both the rate and extent of absorption.
Subject: glimepiride
diabetes
bioequivalence
liquid chromatography
Country: Brasil
Editor: Sbem-soc Brasil Endocrinologia & Metabologia
Rights: aberto
Date Issue: 2007
Appears in Collections:Artigos e Materiais de Revistas Científicas - Unicamp

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