ABSTRACT
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.
Subject(s)
Glipizide/pharmacokinetics , Hypoglycemic Agents/pharmacokinetics , Adult , Area Under Curve , Chromatography, High Pressure Liquid , Glipizide/administration & dosage , Glipizide/analysis , Humans , Hypoglycemic Agents/administration & dosage , Hypoglycemic Agents/analysis , Male , Reproducibility of Results , Tablets , Therapeutic EquivalencyABSTRACT
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.