Study on the Relative Bioavailability of Domestic Ciclosporin Soft Capsules / 中国药房

ABSTRACT

OBJECTIVE:To compare the relative bioavailability and pharmacokinetic parameters of domestic ciclosporin soft capsules with those of imported ciclosporin soft capsules METHODS:The drug concentration in blood were assayed by TDx after administration of a single oral dose of 300mg domestic or imported ciclosporin soft capsules to each of 12 healthy male volunteers in a randomized crossover study RESULTS:The AUC were(10 47?1 74)?g/(ml?h)and(10 71?1 45)?g/(ml?h),the Cmax were(1 91?0 31)?g/ml and(1 88?0 22)?g/ml,Tmax were(1 46?0 26)h and (1 38?0 31)h,for domestic and imported soft capsules,respectively The relative bioavailability of domestic ciclosporin soft capsules to imported ones was (97 59?9 71)% CONCLUSION:The result showed that the two soft capsules were bioequivalent