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Type: Artigo de periódico
Title: Bioequivalence Of Two Tablets Formulations Of Escitalopram Oxalate In Healthy Volunteers Under Fasting Conditions [bioequivalência De Duas Formulações De Oxalato De Escitalopram Comprimidos Em Voluntários Sadios Administradas Em Jejum]
Author: Marcolongo R.
Zanin M.E.
Meurer E.C.
Marchioretto M.A.
Coelho E.C.
Calafatti S.
Pedrazzoli J.
Abstract: This study was conducted in order to access the bioequivalence of two tablets containing escitalopram oxalate 10 mg. Thirty-two healthy, male and female volunteers took part in the randomized, two-way, crossover study, with a minimum washout period of 10 days. One tablet of either formulation was administered after a 10h overnight fasting. After dosing, serial blood samples were collected during a period of 144 hours. Plasma samples were analyzed for escitalopram by a validated liquid chromatography coupled with tandem mass spectrometry detection (LC-MS-MS). Pharmacokinetic parameters area under the plasma concentration time curve from time zero to the last non-zero concentration time (AUC0-t) and maximum observed concentration (Cmax) were the main evaluation criteria for bioequivalence assessment between formulations. Area under the curve form time zero to infinity (AUC 0-inf), time to Cmax (Tmax) and half-life (t1/2) were also evaluated. The 90% confidence intervals (CI) obtained by analysis of variance (ANOVA) did not show any significant difference between the two formulations and fell within the pre-defined range (96,91-106,79 for AUC0-t and 89,40-102,39 for Cmax) Bioequivalence between the two products was therefore concluded both in terms of rate and extent of absorption. © Copyright Moreira Jr. Editora.
Citation: Revista Brasileira De Medicina. , v. 66, n. 11, p. 375 - 379, 2009.
Rights: fechado
Date Issue: 2009
Appears in Collections:Unicamp - Artigos e Outros Documentos

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