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Type: Artigo de periódico
Title: Comparative bioavailability study with two gemfibrozil tablet formulations in healthy volunteers
Author: Borges, NCD
Mendes, GD
Barrientos-Astigarraga, RE
Zappi, E
Mendes, FD
De Nucci, G
Abstract: Objective: To assess the bioequivalence of gemfibrozil (CAS 25812-30-0) 900 mg tablet formulation from EMS Farmaceutica as test formulation versus a 900 mg tablet formulation as reference in 36 healthy volunteers of both sexes. Methods; The study was conducted using an open, randomized, two-period crossover design with a 1-week washout interval. Plasma samples were obtained over a 24-h period. Plasma gemfibrozil concentrations were analyzed by liquid chromatography coupled to tandem mass spectrometry (LC-MS-MS) with negative ion electrospray ionization using multiple reaction monitoring (MRM). From the gemfibrozil plasma concentration vs; time curves, the following pharmacokinetic parameters were obtained: AUC(last), AUC(0-inf) and C-max. Results: The limit of quantification was 0.05 mu g/mL for plasma gemfibrozil analysis. The geometric mean and respective 90 % confidence interval (CI) of Test/Reference percent ratios were 90.29 (81.39-100.17) for C-max, 96.26 (90.33-102.59) for AUC(last), 96.04 (90.21-102.23) for AUC(0-24h) and 96.62 (90.82-102.78) for AUC(0-alpha). (81.39-100.17) for C-max, 96.26 (90.33-102.59) for AUC(last), 96.04 (90.21-102.23) for AUC(0-24h) and 96.62 (90.82-102.78) for AUC(0-alpha). Conclusion: Since the 90 % Cl for AU-C-last, AUC(0-inf) and C-max ratios were within the 80-125 % interval proposed by the US FDA, it was concluded that gemfibrozil 900 mg tablet (test formulation) was bioequivalent to the 900 mg tablet reference formulation for both rate and extent of absorption.
Subject: CAS 25812-30-0
gemfibrozil, bioavailability, pharmacokinetics
lipid reducer
Country: Alemanha
Editor: Ecv-editio Cantor Verlag Medizin Naturwissenschaften
Citation: Arzneimittel-forschung-drug Research. Ecv-editio Cantor Verlag Medizin Naturwissenschaften, v. 55, n. 7, n. 382, n. 386, 2005.
Rights: aberto
Date Issue: 2005
Appears in Collections:Unicamp - Artigos e Outros Documentos

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