OBJECTIVE To investigate the effect of food on the relative bioavailability and pharmacokinetics of fenofibrate micronised capsule versus Lipanthyl capsule in healthy volunteers.METHODS Under fasting and high-fat breakfast fed condition,a single dose of 200 mg fenofibrate micronised capsule and Lipanthyl capsule was given to 24 healthy volunteers using an open-label,randomized,two-way crossover design.Fenofibric acid levels in plasma were determined by validated HPLC methods.RESULTS The pharmacokinetic parameters of fenofibrate micronised capsule and Lipanthyl capsule under fasting condition were as following:AUC0→96(208.4±65.0)and(155.7±108.9)mg·h·L-1,ρmax(10.1±3.0)and(5.33± 3.8)mg·L-1tmax(4.1± 0.6)and(6.0±2.6)h,respectively.Then the main pharmacokinetic parameters of fenofibrate micronised capsule and Lipanthyl capsule under high-fat breakfast fed condition were as follows AUC0→96(221.7±57.6)and(220.5±58.2)mg·h·L-1,ρmax(14.2±2.5)and(14.4±2.6)mg·L-1,tmax(4.9±0.9)and(4.5±1.1)h,respectively.The relative bioavailability of fenofibrate micronised capsule versus Lipanthyl capsule under fast condition was(153.2±40.0)% and was bioinequivelent.Then under high-fat breakfast fed condition,the relative bioavailability of fenofibrate micronised capsule versus Lipanthyl capsule was(101.2±12.0)% and was bioequivalent.CONCLUSION High-fat breakfast can little modify either the relative bioavailability or pharmacokinetic profile(except ρmax)of fenofibrate micronised capsule,but the AUC and ρmax of Lipanthyl capsule can be highly increased under high-fat breakfast fed condition.
LI Zhong-dong;GO Zhi-wei;SHI Xio-jin;JIO Zheng;WNG ei;ZHONG Ming-kng;WNG Hong-tu.
Effect of Food on Relative Bioavailability of Fenofibrate Micronised Capsule [J]. Chinese Pharmaceutical Journal, 2007, 42(17): 1337-1339
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