Abstract��
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,��max(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,��max(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 ��max)of fenofibrate micronised capsule,but the AUC and ��max of Lipanthyl capsule can be highly increased under high-fat breakfast fed condition.
2007, Vol. 42 