Study on the Pharmacokinetics and Bioequivalence of Mycophenolate Mofetil Soft Capsules / 中国药房

ABSTRACT

OBJECTIVE:To study the relative bioavailability and pharmacokinetics of Mycophenolate mofetil capsules vs.Mycophenolate mofetil soft capsules in healthy volunteers.METHODS:In double period randomized crossover study,20 healthy volunteers were given a single oral dose of trial capsule and reference capsule 4 pills(0.25 g per pill).The concentration of mycophenolate(MPA) was determined by HPLC.Pharmacokinetic parameters were calculated using DAs 2.0 software and the bioequivalence of 2 formulations were evaluated.RESULTS:Main pharmacokinetic parameters of trial capsule vs.reference capsule were as followsAUC0→t(69.95?14.13)?g?h?mL-1 vs.(66.95?19.05)?g?h?mL-1;AUC0→∞(85.18?20.51)?g?h?mL-1 vs.(77.39?23.78) ?g?h?mL-1;Cmax(31.26?13.09)?g?mL-1 vs.(31.90?14.45)?g?mL-1;tmax(0.875?0.358)h vs.(0.775?0.291)h.The relative bioavailability of Mycophenolate mofetil soft capsules in 20 healthy volunteers was(109.6?26.9)%.CONCLUSION:Results of study indicated the 2 formulations are bioequivalent.