RESUMO
In this open, randomized, two way crossover, bioequivalence study, two 5 mg tablet preparations of glipizide (Glipizyd tabl. 5 mg, Tarchominskie Zaklady Farmaceutyczne POLFA S.A., and Glibenese tabl. 5 mg, Pfizer), were compared in 24 healthy male volunteers. Pharmacokinetic variables (mean maximum plasma concentration, mean time to reach maximum plasma concentration, and the mean area under the plasma concentration-time curve) were not statistically significantly different for the two formulations. It can be concluded that the two tablet preparations of glipizide are likely to be bioequivalent.
Assuntos
Glipizida/farmacocinética , Hipoglicemiantes/farmacocinética , Adulto , Área Sob a Curva , Cromatografia Líquida de Alta Pressão , Glipizida/administração & dosagem , Glipizida/análise , Humanos , Hipoglicemiantes/administração & dosagem , Hipoglicemiantes/análise , Masculino , Reprodutibilidade dos Testes , Comprimidos , Equivalência TerapêuticaRESUMO
A simple and selective analytical method for the determination of buspirone analogue--mesmar in rat plasma is described. The procedure involves liquid-liquid extraction followed by reversed-phase high-performance chromatographic analysis with UV detection at 245 nm. No endogenous compounds were found to interfere. The absolute extraction recovery from plasma samples was 76%. The linearity was assessed in the range 0.12-2.44 nmol/ml. Stability of mesmar during processing (autosampler) and in plasma was checked. This method proved suitable for pharmacokinetic studies following single oral dose in rats.
