Bioequivalence of Domestic and Imported Fenofibrate Capsules in Healthy Volunteers

OBJECTIVE: To evaluate the bioequivalence of domestic and imported Fenofibrate capsules in healthy volunteers. METHODS: In double-period crossover study, 18 healthy volunteers received a single oral dose of domestic Fenofibrate capsule 200 mg (test capsule) and imported capsule 200 mg (reference capsule). The content of fenofibric acid in plasma was measured with HPLC. BECS pharmacokinetics program was used to calculate the pharmacokinetic parameters and bioavailability and to evaluate the bioequivalence of two preparations. RESULTS: The main pharmacokinetic parameters of domestic Fenofibrate capsule vs. imported Fenofibrate capsule were as follows: t1/2(21.34±3.31) h vs.(21.83±4.35) h, Cmax(7.31±2.65) mg·L-1 vs. (7.28±2.66) mg·L-1, tmax(4.72±0.57) h vs.(4.67±0.59) h, AUC0～72(170.09±54.06) mg·h·L-1 vs. (172.2±54.64) mg·h·L-1, AUC0～∞(188.56±55.27) mg·h·L-1 vs. (192.27±56.62) mg·h·L-1. The relative bioavailability F0～72 and F0～∞ of domestic Fenofibrate capsule were(98.87±6.76)% vs.(98.00±6.72)%, respectively. Non-parameter test of tmax and variance analysis and t-test of Cmax and AUC0～72 showed there was no statistical difference between 2 kinds of Fenofibrate capsules. The 90% confidential intervals of AUC0～72 and Cmax of test capsule were 83.3%～116.9% and 81.1%～124.4%, respectively. CONCLUSION: The domestic and imported Fenofibrate capsules are bioequivalent.