Pharmacokinetic and bioequivalence study of two gemfibrozil preparations.
A comparative pharmacokinetic study has been performed in 19 healthy male volunteers in a single-dose, randomized, two way cross-over design with two preparations of gemfibrozil (CAS 25812-30-0) capsules each of them containing 300 mg active ingredient. The test preparation was Innogem 300 mg capsule. The plasma concentration of gemfibrozil was determined by a validated HPLC-UV analytical method. The statistical comparison of individual pharmacokinetic parameters (AUC0-16, AUC0-oc Cmax, tmax) of the two capsule preparations was performed by three-way analysis of variance (ANOVA), Wilcoxon's, Westlake's, Schuirmann's and Hanck-Anderson's method as well as by the calculation of confidence intervals on the ratio of test/reference. The relative bioavailability of the test preparation with respect to the reference preparation in terms of the AUC0-oc was 104.06 +/- 21.61%. No statistically significant difference was found between the pharmacokinetic parameters, calculated from plasma concentration-time curves, indicating that the two preparations were bioequivalent.
Benkö
S
S
Department of Pharmacokinetics, EGIS Pharmaceuticals Ltd., Budapest, Hungary.
Drabant
S
S
Grézal
G
G
Urmös
I
I
Csörgö
M
M
Klebovich
I
I
D000328:Adult; D019540:Area Under Curve; D002214:Capsules; D002851:Chromatography, High Pressure Liquid; D004311:Double-Blind Method; D015248:Gemfibrozil / Q000008:administration & dosage / Q000493:pharmacokinetics*; D006207:Half-Life; D006801:Humans; D000960:Hypolipidemic Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D008297:Male; D013056:Spectrophotometry, Ultraviolet; D013810:Therapeutic Equivalency
D002214:Capsules; D000960:Hypolipidemic Agents; D015248:Gemfibrozil