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Type: Artigo de periódico
Title: Comparative Bioavailability Of Two Captopril Formulations In Healthy Volunteers After A Single Dose Administration [biodisponibilidade Comparativa De Duas Formulações De Captopril Em Voluntários Sadios Após A Administração De Uma Dose única]
Author: Do Carmo Borges N.C.
Heleno M.A.G.
Moreno R.A.
Abstract: Objective: To compare the bioavailability of a captopril 50 mg tablet formulation from Cinfa Brasil Ltda. (test formulation) and Capoten® 50 mg tablet formulation from Bristol-Myers Squibb Brasil S.A. (reference formulation) in 26 volunteers of both sexes. Material and methods: The study was conducted open with randomized two-period crossover design and a two-weeks washout period. Plasma samples were obtained over a 12-hour interval. Captopril concentrations were analyzed by combined liquid chromatography and tandem mass spectrometry (LC-MS-MS) with positive ion electrospray ionization using selected ion monitoring method. From the captopril plasma concentration versus time curves the following pharmacokinetic parameters were obtained: AUC(0-last); AUC(0-t); AUC(0.∞); Ke; T1/2; C max and Tmax. Results: Geometric mean of captopril/Capoten® 50 mg individual percent ratio was 111.13% for AUC (0-t), 110.58% for AUC(0-∞) and 108.22% for C max. The 90% Cl was 103.16 to 119.72%, 103.00 to 118.72% and 96.59 to 121.24% respectively. Conclusion: Since the 90% Cl for both Cmax, AUC0-t, and AUC0-inf were within the interval proposed by the ANVISA RDC 135 (may, 2003), it was concluded that captopril 50 mg tablets (Cinfa Brasil Ltda.) was bioequivalent to Capoten® 50 mg (Bristol-Myers Squibb S.A.), according to both the rate and extent of absorption. © Copyright Moreira Jr. Editora. Todos os direitos reservados.
Citation: Revista Brasileira De Medicina. , v. 63, n. 10, p. 518 - 522, 2006.
Rights: fechado
Date Issue: 2006
Appears in Collections:Unicamp - Artigos e Outros Documentos

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