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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.|
|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.|
|Appears in Collections:||Unicamp - Artigos e Outros Documentos|
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