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Type: Artigo de periódico
Title: A Replicated Study Of Relative Bioavailability Of Two Formulations Of Sodium Ibandronate In Healthy Female (postmenopausal And Non-menopausal) And Male Volunteers [estudo Replicado De Biodisponibilidade Relativa De Duas Formulações De Ibandronato De Sódio Em Voluntários Sadios Dos Sexos Feminino (pós-menopausa E Não Menopausa) E Masculino]
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 ibandronate sodium 150 mg tablets (ibandronate sodium of Aché S/A testing and formulation of Bonviva® Roche Products Chemicals and Pharmaceuticals S.A. reference formulation, Brazil) in 80 volunteers of both sexes (20 female volunteers in post-menopausal, 20 volunteers sex femino not in menopause and 40 male volunteers). This was an open, replicated, randomized, two-sequence, four-period, crossover in two treatments, in which a group of volunteers received the test formulation and the other reference formulation. Plasma samples were obtained throughout a 72 hours interval. The concentrations of sodium ibandronate were determined by mass spectrometry (UPLC-MS-MS) using deuterated ibandronate as internal standard. From the data obtained, calculate the following pharmacokinetic parameters: AUC 0-t, AUC 0-∞ and Cmax. The geometric mean of ibandronate sodium / Bonviva® 150 mg individual percent ratio were 102.18% for AUC 0-t, 102.14% for AUC 0-∞, and 100.64% for Cmax. The 90% confidence intervals were 94, 89-110.03%, 94.92-109.91%, 91.88-110.23%, 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 sodium Thandronate 150 mg was bioequivalent to Bonviva® tablet of 150 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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