Abstract

RAMIREZ CORREA, Gloria Shirley et al. Bioequivalence comparison of two formulations of oxcarbazepine tablets: a two period, single dose, randomized, cross-over study. Iatreia [online]. 2009, vol.22, n.3, pp.205-212. ISSN 0121-0793.

Two formulations of oxcarbazepine (Trileptal^®, Novartis, y Oxcarbazepina^®, Tecnoquímicas S. A.), previously shown to be pharmaceutical equivalents, were evaluated concerning their bioequivalence by means of a randomized, crossover, single oral dose (1.200 mg), two-period study in 24 healthy adult males. The following pharmacokinetic parameters were determined: Area under the curve (AUC), Maximal concentration (C_max), and Time to reach maximal concentration (T_max). There was a 206 wash-out interval of seven days between the two periods. Plasmatic concentrations of the drug were measured with HPLC/UV with standard addition. No significant differences were found between the two preparations. It was concluded that they are pharmaceutical equivalents as well as bioequivalent. Consequently, they are interchangeable for therapeutic purposes.

Keywords : Bioequivalence; Oxcarbazepine tablets.

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