Estudo de bioequivalencia de duas formulações de diclofenaco em voluntarios sadios

AUTOR(ES)
DATA DE PUBLICAÇÃO

1999

RESUMO

Objective: To compare the reI ative bioavailability and to assess the bioequivalence of two different diclofenac formulations (diclofenac suspension as test formulation and diclofenac drop suspension, reference formulation, both by Novartis Biociência, Brazil) in twenty-four healthy volunteers (12 male and 12 female). Methods: After an overnight fast, the volunteers received a single oral dose of each formulation (50 mg), following an open, randomized, two-period crossover design, with a fourteen-day washout interval between doses. Serum samples were obtained over a 24 h interval post-dosing, and were analyzed for their diclofenac content by reverse-phase High Pressure Liquid Chromatography with ultraviolet detection (HPLC-UV). The following pharmacokinetic parameters were obtained after each dose administration: AUC(o-oo), AUC(O-24h), Cmax, Tmax, T 1/2 and Ke. Results: No adverse effect was reported for any of the formulations administered. Geometric mean test/reference individual percent ratios were: 92.8% for AUC(0-24h), 93.2 AUC(O-oo), 117.2% for Cmax, 131.0% for Ke, and 76.2% for Tl/2- The . variability of Cmax parameter expressed as variation coefficient was greater than 25%. The 90% confidence interval (CI) for the geometric mean of AUC and Cmax were included into the bioequivalence range. Arithmetic mean for individual Tmax differences was ~.24 and the 90% CI includes the zero value. Conc/usion: Based on these considerations the obtained results and I Íhe, European Community mIes for human bioequivalence trial, can be concluded bioequivalence for both, rate and extent of absorption between both formulations after single oral dose administration

ASSUNTO(S)

medicamentos - biodisponibilidade farmacocinetica cromatografia liquida de alta eficiencia

ACESSO AO ARTIGO

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