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Type: Artigo de periódico
Title: Study Of Relative Bioavailability/bioequivalence Of Two Formulations Of Risendronate Sodium In Healthy Volunteers Of Both Sexes [estudo De Biodisponibilidade Relativa/bioequivalência De Duas Formulações De Risedronato De Sódio 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 Risedronate Sodium 35 mg tablet (risedronate sodium of Aché S/A test formulation and Actonel® from Sanofi-Aventis Pharmaceuticals Inc. reference formulation, Brazil) in 80 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 risedronate sodium concentrations were determined by mass spectrometry (UPLC-MS-MS) using risedronic acid-D4 (deuterated risedronate) as internal standard. From the data obtained, calculate the following pharmacokinetic parameters: AUC 0-t, AUC 0-∞ and Cmax. The geometric mean of risedronate sodium /Actonel ® 35 mg were 101.90% for AUCO-t, 97.95% for AUC 0-∞ and 100.70% for Cmax. The 90% confidence intervals were 86.43%-120.14%, 83.04%-115.54% and 85.50%-118.61%, 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 tablet of sodium risedronate 35 mg was bioequivalent to Actonel ® tablet of 35 mg and thus the test product may be considered interchangeable in medical practice. © Copyright Moreira Jr. Editora. Todos os direitos reservados.
Rights: fechado
Identifier DOI: 
Date Issue: 2012
Appears in Collections:Unicamp - Artigos e Outros Documentos

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