A comparison of the bioavailability of standard or micronized formulations of fenofibrate

Abstract

This study compared the quantities of fenofibrate absorbed after administration of either standard or micronized formulations by using a balanced crossover design trial. The morning after an overnight fast, and immediately after the ingestion of a standard breakfast, each of 24 healthy men received one of two formulations: one Lipanthyl® 100 capsule containing 100 mg of standard fenofibrate, or one Lipanthyl® 67 M capsule containing 67 mg of micronized fenofibrate. After a 7-day washout period to allow the total elimination of the active metabolite, fenofibric acid, one capsule of the other formulation was given under similar conditions. During each study period, blood samples were drawn before administration of the drug, and then at hourly (for first 8 hours), bihourly (at 8 to 12 hours), and daily (at 1 to 5 days) intervals. The following pharmacokinetic parameters were determined for each treatment and for all subjects: maximal observed concentration (C max), time of appearance of the concentration peak (t max), area under the plasma concentration versus time curve, extrapolated to infinity (AUC ∞), and the apparent elimination half-life (t 1/2). After data analysis, there were no statistically significant differences between the C max, t 1/2, and AUC ∞ values obtained for the two formulations, suggesting that Lipanthyl 67 M is bioequivalent to Lipanthyl 100.