PHARMACOKINETIC AND BIOEQUIVALENCE STUDY OF 2 GEMFIBROZIL PREPARATIONS

A comparative pharmacokinetic study has been performed in 19 healthy m ale volunteers in a single-dose, randomized, two way cross-over design with two preparations of gemfibrozil (CAS 25812-30-0) capsules each o f them containing 300 mg active ingredient. The test preparation was I nnogem(R) 300 mg capsule. The plasma concentration of gemfibrozil was determined by a validated HPLC-UV analytical method. The statistical c omparison of individual pharmacokinetic parameters (AUC(0-16), AUC(0-i nfinity), C-max, t(max)) of the two capsule preparations was performed by three-way analysis of variance (ANOVA), Wilcoxon's Westlake's, Sch umann's and Hauck-Anderson's method as well as by the calculation of c onfidence intervals on the ratio of test/reference. The relative bioav ailability of the test preparation with respect to the reference prepa ration in terms of the AUC(0-infinity) was 104.06 +/- 21.61%. Na stati stically significant difference was found between the pharmacokinetic parameters, calculated from plasma concentration-time curves, indicati ng that the two preparations were bioequivalent.