Bioequivalence of Mycophenolate Mofetil Capsules in Human Body / 中国药房

ABSTRACT

OBJECTIVE:To study the bioequivalence of the domestic and the imported mycophenolate mofetil capsules in human body.METHODS:A single dose of 1 000mg domestic mycophenolate mofetil capsules(trial)or its reference capsule(imported ones)were given to each volunteer in a randomized double cross-over design.The plasma concentration was determined by RP-HPLC.The pharmacokinetic parameters of two preparations were calculated and the bioequivalence of which was evaluated.RESULTS:The main pharmacokinetic parameter of the trial vs.the reference preparations of mycophenolate mofetil capsules were as followsCmax(26.38?9.55)versus(25.84?12.08)?g?mL-1;tmax(0.79?0.40)h versus(0.94?0.59)h;t1/2(18.01?7.65)h versus(15.62?8.50)h;AUC0～48(54.69?15.58)versus(51.68?12.36)?g?h?mL-1;AUC0～∞(61.10?17.06)versus(57.99?17.21)?g?h?mL-1.The relative bioavailability of the trial preparation was(107.22?25.39)%.CONCLUSION:The results suggest that the two formulations are bioequivalent.