S.E. Leucuța *, Adina Popa *, Marcela Achim *, R. Capalneanu *, M. Bojiță*
* S.E. Leucuța, Adina Popa, Marcela Achim, R. Capalneanu, M. Bojiță – University of Medicine and Pharmacy “luliu Hatieganu” Cluj Napoca, Department of Biopharmaceutics and Pharmacokinetics
Abstract
The purpose of the present bioequivalence study was to compare two different formulations of carbamazepine tablet (200 mg): Finlepsin (Asta Medica AG, test formulation) and Tegretol (Novartis, reference formulation). The study was carried out on 12 healthy male volunteers who received a single dose of 200 mg of the test and reference products in the fasting state, in a randomized, two period, two treatment, two sequence crossover study. Plasma concentration time profiles of carbamazepine and its active metabolite carbamazepine-10, 11-epoxide were determined until 120 hours after administration. The quantitative drug and metabolite analysis was done with a validated HPLC method. Tested dosage form was considered bioequivalent to reference dosage form with regard to the extent of absorption, if the 90% confidence intervals of the area under the curve ratio and of the maximum concentration ratio (log mean values) were within the range of 0.80-1.25 (Schuirman’s two one sided t test) and with regard to rate of absorption if the difference of the mean values of the time of maximum concentration was not significant assuming an additive model (Friedman nonparametric test). Carbamazepine test tablets were bioequivalent to reference with regard to extent and rate of absorption after single dose administration.