Artículos de revistas
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]
Registro en:
Revista Brasileira De Medicina. , v. 70, n. 1/Fev, p. 31 - 35, 2013.
347264
2-s2.0-84874972714
Autor
Abib Jr. E.
Duarte L.F.
Pereira R.
Lemes A.B.
Morais D.C.
Lima L.G.
Savio D.
Pengo S.
Institución
Resumen
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. 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