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Type: Artigo de periódico
Title: Study Of Relative Bioavailability/bioequivalence Of Two Formulations Of Valsartan In Healthy Volunteers For Both Sexes [estudo De Biodisponibilidade Relativa/bioequivalência De Duas Formulações De Valsartana Em Voluntários Sadios De Ambos Os Sexos]
Author: Abib Jr. E.
Duarte L.F.
Pereira R.
Lemes A.B.
Morais D.C.
Lima L.G.
Savio D.
Pengo S.
Abstract: The study was conducted to compare the bioavailability of two formulations of Valsartan 320 mg coated tablet (Valsartan of Aché S/A test formulation and Diovan® from Novartis Biociências S.A. reference formulation, Brazil) in 108 volunteers both sexes. This was an open, randomized, two-sequence, two-period, crossover single dose two treatments, in which a group of volunteers received the test formulation and the other reference formulation. Blood samples were obtained throughout a 48 hours interval. The Valsartan concentrations were determined by mass spectrometry (HPLC-MS-MS) using Losartan as internal standard. From the data obtained, calculate the following pharmacokinetic parameters: AUC0-t, AUC0-∞ and Cmax. The geometric mean of Valsartan/Diovan® 320 mg were 103.63% for AUC1-t, 102.72% for AUC0-∞ and 102.96% for Cmax. The 90% confidence intervals were 96.24%-111.59%, 95.64%-110.34% and 95.51%-110.98%, respectively. Since the confidence intervals 90% for Cmax and AUC0-t. was within the range 80%-125% proposed by the FDA and ANVISA (National Agency of Sanitary Surveillance in Brazil), it is concluded that the coated tablet of Valsartan 320 mg was bioequivalent to Diovan® coated tablet of 320 mg and thus the test product may be considered interchangeable in medical practice. © Copyright Moreira Jr. Editora.
Rights: fechado
Identifier DOI: 
Date Issue: 2012
Appears in Collections:Unicamp - Artigos e Outros Documentos

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