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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 [estudo Comparativo Da Biodisponibilidade Relativa De Duas Formulações De Glimepirida Em Voluntários Sadios De Ambos Os Sexos Após Administração De Uma Dose única De Um Comprimido De 4 Mg]
Author: Borges N.C.D.C.
Taveira Y.D.A.
Mazucheli J.A.
Haddad A.L.
Astigarraga R.E.B.
Moreno R.A.
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-∞), K e, T 1/2, C max, and T max. Results: Geometric mean of Glimepirida/Amaryl® 4 mg was 102.35% for AUC (0-t), 102.35% for AUC (0-∞) and 99.31% for C max. The 90% CI was 92.62-109.55%; 95.62-109.55% e 88.60-111.32%, respectively. Conclusion: Since the 90% CI for both C max, AUC (0-t), and AUC (0-∞) were within the interval of 80-125%, it was concluded that both formulations were bioequivalent, according to both the rate and extent of absorption.
Rights: aberto
Identifier DOI: 
Date Issue: 2007
Appears in Collections:Unicamp - Artigos e Outros Documentos

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