Abstract��
OBJECTIVE To establish a simple extract method for the analysis and quantitative determination of fenofibric acid in plasma,and compare relative bioavailability of fenofibrate test preparations with reference preparations in healthy volunteers.METHODS Blood sample with diazepam was deproteinized by acetonitrile.A total of 18 healthy male volunteers were administered with two preparations of fenofibrate in a randomized crossover design.Fenofibric acid was determined by HPLC after a single oral administration of 200 mg in healthy volunteers.The pharmacokinetic parameters and relative bioavailability of fenofibric acid were obtained using DAS software.RESULTS Fenofibric acid,the active circulating metabolite of fenofibrate,was obtained from blood sample.The retention times(tR)of fenofibric acid and diazepam were about 4.10 and 5.40 min,respectively.The pharmacokinetic parameters of fenofibric acid for test preparations(T)and reference preparations(R)were as following:��max were(9.04��1.65)and(9.51��1.77)mg��L-1,tmax were(4.61��1.04)and(5.0��0.77)h,t1/2 were(19.75��6.17)and(18.98��5.40)h,AUC0-t were(151.96��41.76)and(160.59��50.07)mg��h��L-1,respectively.The relative bioavailability of test preparations(F0-t)was calculated to be(97.5��22.6)%,compared with reference preparations.CONCLUSION The two preparations of fenofibrate are bioequivalent.
YU Jun-xian,
YANG Chun-xiu,
WANG Man-li etc
.Relative Bioavailability of Fenofibrate Capsules in Healthy Volunteers [J] Chinese Pharmaceutical Journal, 2008,V43(15): 1177-1179
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2008, Vol. 43 
