Pharmacokinetics and Bioequivalence of Mycophenolate Mofetil Dry Suspension in Healthy Volunteers / 中国药房

ABSTRACT

OBJECTIVE:To study the pharmacokinetics and the bioequivalence of mycophenolate mofetil(MMF)dry suspension versus its imported tablets counterpart in healthy volunteers.METHODS:In a randomized two period crossover study,each of the 20 healthy male volunteers received a single oral dose of 0.75 mg dry suspension or imported tablet of MMF.The plasma concentration of mycophenolic acid(MPA),which is the active metabolite of MMF,were determined by HPLC.The pharmacokinetics of MPA were estimated by the non-compartment model and the bioequivalence of the two formulations of MMF were evaluated by ANOVA and two one-sided-test.RESULTS:The main pharmacokinetic parameters of MMF dry suspension versus imported MMF tablet were as followst1/2? were(16.80?4.10)and(16.77?4.50)h;tmax were(0.4?0.1)and(0.7?0.4)h;Cmax were(19.29?6.78)and(18.22?7.19)?g?mL-1;AUC0～72 were(39.22?10.43)and(39.38?10.46)?g?h?mL-1,and AUC0～∞ were(40.58?10.49)and(41.00?10.88)?g?h ?mL-1 respectively.The relative bioavailability of the test preparation(dry suspension of MMF)was(100.9?10.6)%.CONCLUSION:The two formulations are bioequivalent in healthy volunteers.