Pharmacokinetics of Fenofibrate Double-layer Osmotic Pump Tablets in Beagle dogs in vivo

Objective To study the pharmacokinetics of Fenofibrate Double-layer Osmotic Pump Tablets and evaluate the bioequivalence between tested preparation and reference preparation in Beagle's dogs. Methods The concentration of fenofibric acid in plasma was determined by LC-MS. Also, the pharmacokinetic parameters of Fenofibrate Double-layer Osmotic Pump Tablets in vivowere calculated by pharmacokinetic software DAS 2.1.1. Results The main pharmacokinetic parameters of the tested preparation and reference preparation were as follows. The Cmax were(1 100.0 ± 771.2) and(924.3 ± 564.0) ng/L, tmax were(6.7 ± 8.5) and(2.5 ± 0.5) h, AUC0-t were(17 841.1 ± 12 220.7) and(17 615.5 ± 12 870.2) ng·h/mL, t1/2 were(17.7 ± 8.2) and(16.4 ± 3.3) h, MRT0-t were(24.7 ± 4.0) and(24.5 ± 5.2) h, the relative bioavailability of fenofibric acid in the tested preparation was(104.7 ± 12.4)%. Conclusion The test preparation and reference preparations are bioequivalent.