Pharmacokinetics and bioavailability of fenofibrate sustained release tablets in healthy volunteers

Aim To study the pharmacokinetics and bioavailability of fenofibrate sustained release tablets in healthy volunteers.Methods Twenty healthy male volunteers were enrolled in a randomized open-label,two-crossover study given a single dose of 0.25 g fenofibrate sustained release tablets and fenofibrate sustained release capsules.Twenty-four healthy male volunteers were enrolled in a randomized open-label,two-crossover study given multi-dose of 0.25 g fenofibrate sustained release tablets and fenofibrate sustained release capsules for 6 days.The concentrations of fenofibric acid in plasma were determined by HPLC method.Pharmacokinetic parameters were comparable.Average bioequivalence was determined by DAS2.0 program.Results The main pharmacokinetic parameters of fenofibrate sustained release tablets and fenofibrate sustained release capsules were as follows,single-dose:t1/2(5.25±1.27) and(4.93±0.71) h,Cmax(8.58±2.77) and(9.75±3.44) mg·L-1;AUC0-96(188.34±65.66)and(194.02±56.58) mg·h-1·L-1.multi-doses :tmax(5.06±0.92)and(5.04±0.93)h;Cav(7.25±2.32)and(8.03±3.27) mg·L-1;AUCss(174.06±55.67) and(192.66±78.53) mg·h-1·L-1.Conclusion The pharmacokinetic parameters were similar after administration of fenofibrate sustained release tablets and fenofibrate sustained release capsules.The two kinds of fenofibrate are of bioequivalence.