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Type: Artigo de periódico
Title: Study Of Relative Bioavailability/bioequivalence Of Two Formulations Of Donepezil Hydrochloride In Healthy Volunteers For Both Sexes [estudo De Biodisponibilidade Relativa/bioequivalência De Duas Formulações De Cloridrato De Donepezila 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 donepezil hydrochloride 10.0 mg coated tablet (donepezil hydrochloride of Aché S/A test formulation and Eranz® from Wyeth Whitehall Ltda. reference formulation, Brazil) in 30 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 Donepezil concentrations were determined by mass spectrometry (UPLC-MS-MS) using Loratadine as internal standard. From the data obtained, calculate the following pharmacokinetic parameters: ASC0-t, ASC0-∞ and Cmax. The geometric mean of Donepezil Hydrochloride / Eranz® 10.0 mg were 99,79% for ASC0-t, 101.44% for ASC0-∞ and 91.19% for Cmax. The 90% confidence intervals were 94.91-104.9%, 94.12-109.31% and 84.03-98.97%, respectively. Since the confidence intervals 90% for Cmax and ASC0-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 Donepezil Hydrochloride 10.0 mg was bioequivalent to Eranz® coated tablet of 10.0 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: 2013
Appears in Collections:Unicamp - Artigos e Outros Documentos

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