Artículos de revistas
Relative Bioavailability Study Of Pharmacokinetic Evaluation Of Memantine Associated With Donepezil In Healthy Volunteers For Both Sexes [estudo De Biodisponibilidade Relativa Para Avaliação Da Farmacocinética De Memantina Associada A Donepezila Em Voluntários Sadios De Ambos Os Sexos]
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Revista Brasileira De Medicina. Moreira Junior Editora Ltda., v. 72, n. 4, p. 141 - 146, 2015.
347264
2-s2.0-84929582680
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Resumen
The study was conducted to compare the bioavailability of fixed dose combination of memantine 20 mg and donepezil 10 mg coated tablet (Aché SA, test formulation), and Ebix® 10 mg coated tablet (Lundbeck Brazil Ltda, reference formulation) and Eranz® 10 mg coated tablet (Wyeth Pharmaceutical Industry Ltd., reference formulation) in 36 volunteers of both sexes. This was an open, randomized, two-treatment, two-sequence, two-period, crossover, single dose, in which a group of volunteers received the test formulation and other reference formulation. Blood samples were obtained throughout a 96 hours interval. The memantine combined donepezil concentrations were determined by mass spectrometry (UPLC-MS-MS) using amantadine and loratadine as internal standard. The geometric mean of memantine associated with donepezil/Ebix® 10 mg were 98.75% for AUC0-t and 96.95% for Cmax. The 90% confidence intervals were 96.01-101.58% and 93.50-100.54%, respectively. The geometric mean of memantine associated with donepezil / Eranz® 10 mg were 92.03% for AUC0-t and 94.77% for Cmax. The 90% confidence intervals were 89.47-94.67% and 88.22-101.80%, 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 memantine 20 mg associated to donepezil 10 mg was bioequivalent to the concomitant administration of 2 tablets of Ebix® 10 mg and 1 tablet of Eranz® 10 mg and thus the test product may be considered interchangeable in medical practice. © Copyright Moreira Jr. Editora. 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