3×3 Study on bioequivalence of mycophenolate mofetil preparations in healthy male volunteers

AIM To study the bioequivalence of mycophenolate mofetil tablets,capsules and imported preparation(CellCept) by Latin square design. METHODS The serum concentration of 24 volunteers were determined by HPLC after a single oral does of 500 mg of mycophenolate mofetil tablets,capsules and imported preparation in a randomized crossover design.The pharmacokinetic parameters were calculated and the relative bioavailability and bioequivalence of three formulations were evaluated.RESULTS The pharmacokinetic parameters of mycophenolate mofetil tablets,capsules and imported preparation were as follows: AUC0→48:(39.74±8.61),(38.06±9.01)and(36.21±9.17)mg·h·L-1;AUC0→∞:(44.02±10.62),(40.91±9.54)and(39.82±9.21)mg·h·L-1.ρmax:(20.19±9.63),(17.42±6.03)and(18.48±7.06)mg·L-1.tmax;(0.74±0.64),(0.72±0.35)and(0.56±0.20)h;t12:(13.43±4.58),(12.20±3.09) and(13.59±5.40)h;MRT:(14.95±5.85),(13.42±2.83)and(14.40±5.47)h,respectively.CONCLUSION The results indicate that the three mycophenolate mofetil formμlations are bioequivalent.