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Type: Artigo de periódico
Title: Comparative Bioavailability Of Two Sertraline Formulations In Healthy Human Volunteers After A Single Dose Administration [biodisponibilidade Comparativa De Duas Formulações De Sertralina Em Voluntários Humanos Sadios Após A Administração De Uma única Dose]
Author: Duarte Mendes G.
Ferreira De Araujo M.V.
Guelere Paris E.
Barrientos-Astigarraga R.E.
De Oliveira C.H.
Abstract: Objective: To compare the bioavailability of two sertraline tablet (50 mg) formulations (Sertralina from Eurofarma Laboratórios Ltd., Brazil, as test formulation and Zoloft® from Laboratódos Pfizer Ltd., Brazil, as reference formulation) in 24 volunteers of both sexes. Material and methods: The study was conducted open with randomized two-period crossover design and two-weeks washout period. Plasma samples were obtained over a 96-hour interval. Sertraline concentrations were analyzed by combined reversed liquid-phase chromatography and tandem mass spectrometry (LC-MS-MS) with positive ion electrospray ionization using selected ion monitoring method. From the sertraline plasma concentration vs time curves the following pharmacokinetic parameters were obtained: AUClast, AUC0-∞ and C max. Results: Geometric mean of Sertralina/Zoloft® 50 mg individual percent ratio was 98.9% for AUClast, 99.0% for AUC 0-∞ and 93.7% for Cmax. The 90% confidence intervals were 91.4%-107.0%, 89.7-109.4%, and 84.5%-104.0%, respectively. Conclusion: Since the 90% CI for Cmax, AUClast and AUC0-∞ were within the 80-125% interval proposed by the Food and Drug Administration, it was concluded that Sertraline 50 mg tablet by Eurofarma Laboratórios Ltd. was bioequivalent to Zoloft® tablet 50 mg, according to both the rate and extent of absorption.
Rights: fechado
Identifier DOI: 
Date Issue: 2004
Appears in Collections:Unicamp - Artigos e Outros Documentos

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