Comparative pharmacokinetics of two oral bezafibrate preparations

The pharmacokinetics of two oral solid preparations of bezafibrate, available in the Spanish market, was studied. Both preparations were tablets, an immediate-release formulation (A) and the other a slow-formulation (C). We selected a crossover design, and twelve healthy male volunteers participated in the study. Using a sensitive HPLC method, plasma concentrations of bezafibrate were monitored over a period of 12 h. after administration of treatment A and 24 h. for treatment C. In treatment A, two tablets were administered at an interval of six hours. The maximum plasma concentration (Cmax), time to Cmax(tmax) and area under curve (AUC infinity o), in the two doses of treatment A, were compared by analysis of variance and found to be significantly different between the two doses. The relative bioavailability based on (C: 1st-Dose-A) ratio of AUC infinity o was within the range 100 +/- 20%.