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]

dc.creatorAbib Jr. E.
dc.creatorDuarte L.F.
dc.creatorPereira R.
dc.creatorLemes A.B.
dc.creatorMorais D.C.
dc.creatorLima L.G.
dc.creatorSavio D.
dc.creatorPengo S.
dc.date2013
dc.date2015-06-25T19:12:17Z
dc.date2015-11-26T15:09:37Z
dc.date2015-06-25T19:12:17Z
dc.date2015-11-26T15:09:37Z
dc.date.accessioned2018-03-28T22:19:48Z
dc.date.available2018-03-28T22:19:48Z
dc.identifier
dc.identifierRevista Brasileira De Medicina. , v. 70, n. 1/Fev, p. 31 - 35, 2013.
dc.identifier347264
dc.identifier
dc.identifierhttp://www.scopus.com/inward/record.url?eid=2-s2.0-84874972714&partnerID=40&md5=0b4da423ad40f9bfa272802582609a6f
dc.identifierhttp://www.repositorio.unicamp.br/handle/REPOSIP/88737
dc.identifierhttp://repositorio.unicamp.br/jspui/handle/REPOSIP/88737
dc.identifier2-s2.0-84874972714
dc.identifier.urihttp://repositorioslatinoamericanos.uchile.cl/handle/2250/1257858
dc.descriptionThe 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.
dc.description70
dc.description1/Fev
dc.description31
dc.description35
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dc.languagept
dc.publisher
dc.relationRevista Brasileira de Medicina
dc.rightsfechado
dc.sourceScopus
dc.titleStudy 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]
dc.typeArtículos de revistas


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