Bioequivalence of micronized fenofibrate capsule in healthy volunteers

AIM To study the pharmacokinetics and bioequivalence of domestic and imported micronized fenofibrate capsule in healthy volunteers.METHODS In a two-treatment,two-period,two-sequence randomized cross-over trial,20 healthy volunteers were given a single 200 mg oral dose of the test preparation and reference preparation.Plasma concentrations were determined by HPLC method.Ketoprofen was used as the internal standard.The pharmacokinetics parameters were calculated statistically to evaluate the bioequivalence between the two preparations by BAPP 2.2 software.RESULTS The pharmacokinetics parameters of test and reference preparation were as follows:ρmax were(5.3 ± s 2.1)mg·L-1 and(4.4 ± 1.5)mg·L-1;tmax were(6.4 ± 2.5)h and(5.8 ± 1.6)h;t1/2 were(23 ± 5)h and(26 ± 8)h;MRT were(35 ± 8)h and(38 ± 11)h;AUC0-72 were(127 ± 34)mg·h·L-1 and(118 ± 28)mg·h·L-1;AUC0-72 were(145 ± 41)mg·h·L-1 and(140 ± 34)mg·h·L-1,respectively.There was no significant difference between the two preparations.The relative bioavailability of tested capsule was(97± 29)%.CONCLUSION The two preparations are bioequivalent.