Artículos de revistas
Bioequivalence Study And Pharmacokinetic Evaluation Of Two Quetiapine Formulations In Healthy Volunteers After A Single Dose Administration [estudo De Bioequivalência E Avaliação Farmacocinética De Duas Formulações De Quetiapina Em Voluntários Sadios Após Administração De Dose única]
Revista Brasileira De Medicina. , v. 68, n. 9, p. 269 - 273, 2011.
Abib Jr. E.
De Lima L.G.
The study was performed to compare the bioavailability/bioequivalence of two Quetiapine 25 mg tablet formulations (Quetiapine from Aché Laboratórios Farmacêuticos S/A as test formulation and Seroquel® from Astrazeneca Ltda, Brazil, as reference formulation) in 48 volunteers of both sexes. The study was conducted as an open randomized two periods cross-over design with a wash out phase of one week. Plasma samples were obtained over a 36 hour interval. Plasma concentrations of Quetiapine were determined by LC-MS-MS equipment using Clozapine as internal standard. From the data obtained, the following pharmacokinetics parameters were calculated: AUC0-t′, AUC0-∞ and Cmax′ Geometric mean of Quetiapine/Seroquel® 25 mg was 99.96% for AUC 0-t′ 100.12% for AUC0-8 and 92.59% for C max′ the 90% confidence intervals were 93.58-106.77%, 93.88-106.78% and 83.22-103.01%, respectively. Since the 90% confidence intervals for Cmax′ AUC0-t and AUC 0-∞ were within the range of 80-125% proposed by Food and Drug Administration and ANVISA (the National Health Surveillance Agency of Brasil), it was concluded that Quetiapine 25 mg Tablet was bioequivalent to Seroquel® 25 mg tablet, and so the test product can be considered interchangeable in normal medical practice. © Copyright Moreira Jr. Editora. 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