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|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|
|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.|
|Editor:||Sbem-soc Brasil Endocrinologia & Metabologia|
|Appears in Collections:||Artigos e Materiais de Revistas Científicas - Unicamp|
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