| Popis: |
Comparative pharmacokinetic study was performed in 19 healthy male volunteers in a single-dose, randomized, two way cross-over trial on two preparations of gemfibrozil (Innogem and Lopid capsules) each of them containing 300 mg active ingredient. After administration either the test preparation (Innogem, EGIS Pharmaceuticals Ltd.,) or the reference preparation (Lopid, Parke-Davis) in human, the plasma concentration of gemfibrozil was determined by validated HPLC-UV (225 nm) bioanalytical method. After the relatively simple liquid-liquid extraction of the plasma samples the separation was carried out under isocratic condition on Nucleosil 10, C-18 column. On the basis of the validation process the limit of quantitation (LOQ), of the HPLC method was 250 ng/0.5 ml. All the validation parameters fell within the internationally accepted range. The comparison of individual pharmacokinetic parameters (AUC0-16, AUC0-infinity Cmax, tmax) of the two capsule preparations was accomplished by three-way analysis of variance (ANOVA), Wilcoxon's, Westlake's, Schuirmann's and Hauck-Anderson's method as well as by the calculation of confidence intervals on the ratio of test/reference values. The relative bioavailability of Innogem with respect to Lopid 300 mg capsule for AUC0-infinity was 104.06 +/- 21.61%. No statistically significant difference was found in the clinical results and between the pharmacokinetic parameters calculated from plasma concentration-time curves indicating that the two gemfibrozil preparations were bioequivalent after single administration. |
