Estudo de bioequivalencia entre duas formulações de oxcarbazepina de 600mg em voluntarios sadios de ambos os sexos / Bioequivalence study between two 600mg oxcarbazepine formulations in health volunteers of both genders




The purpose of this study was to compare the bioavailability of two oxcarbazepine formulations in 600mg pills - a test formulation produced by Cristália Produtos Químicos Farmacêuticos Ltda with the Trileptal® formulation by Novartis Pharma. Based on the low interindividual variability of this drug and the existing bibliography, the study sample size indicated was 26 volunteers of both sexes, considered healthy according to their physical and laboratory exams, . The plasma samples were quantified by a validated method that used high pressure liquid chromatography with mass spectrometry (LC-MS-MS). The quantification data was used to obtain the concentration curves of oxcarbazepine versus time and metabolite versus time that determined the following pharmacokinetic parameters: the AUC curve- area under the plasma concentration versus time curve, maximum concentration achieved after the dose was administered (Cmax) and the time taken to achieve e maximum concentration (Tmax). We concluded that the 600mg oxcarbazepine formulation produced by Cristália Produtos Químicos Farmacêuticos Ltda was bioequivalent to the 600mg Trileptal® formulation produced by Novartis Pharma in relation to the rate and extent of oxcarbazepine absorption, considering confidence intervals of 90% for geometric ratios established by the Food and Drug Administration (80-125%).


therapeutic equivalency epilepsia medicamentos genericos epilepsy farmacologia pharmacology

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