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Type: Artigo de periódico
Title: Study Of Relative Bioavailability/bioequivalence Of Two Formulations Of Rosuvastatin Calcium In Healthy Volunteers For Both Sexes [estudo De Biodisponibilidade Relativa/bioequivalência De Duas Formulações De Rosuvastatina Cálcica Em Voluntários Sadios De Ambos Os Sexos]
Author: Abib Jr. E.
Duarte L.F.
Pereira R.
Morais D.C.
Lima L.G.
Savio D.
Pengo S.
Abstract: The study was conducted to compare the bioavailability of two formulations of rosuvastatin calcium 20 mg tablet (rosuvastatin calcium of Aché S/A test formulation and Crestor® from AstraZeneca do Brasil Ltda. reference formulation, Brazil) in 24 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 96 hours interval. The rosuvastatin calcium concentrations were determined by mass spectrometry (UPLC-MS-MS) using atorvastatin as internal standard. From the data obtained, calculate the following pharmacokinetic parameters: AUC 0-t, AUC 0-∞ and Cmax. The geometric mean of rosuvastatin calcium/Crestor® 20 mg were 93,97% for AUC 0-t, 97,43% for AUC 0-∞ and 93,63% for Cmax. The 90% confidence intervals were 82,26-107,34%, 85,82-110,61% and 81,58-107,45%, respectively. Since the confidence intervals 90% for Cmax and AUC 0-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 tablet of rosuvastatin calcium 20 mg was bioequivalent to Crestor® tablet of 20 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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