Studies on pharmacokinetics and relative bioavailability of two kinds of cyclosporine capsules

OBJECTIVE To evaluate the bioequivalence of two kinds of cyclosporine capsules.METHODS 300mg single oral dose of cyclosporine Livzon capsule and Sandimmun Neoral capsule were given to 10 volunteers in an open randomized crossover way to study the pharmacokinetics and relative bioavailability.Cyclosporine concentrations in blood were assayed by RP HPLC method.RESULTS The relative bioavailability of cyclosporine Livzon capsule was (102.0±13.7)%.The time concentration curve of cyclosporine Livzon capsule was similar to that of Sandimmun Neoral capsule, and their AUC 0→24 were (7051.4±1084.2) and (6918.5±693.4) ng·h·mL -1 ; c max were (1519.88±219.84) and (1519.69±233.68) ng·mL -1 ; t 1/2α were (1.28±0.38)and (1.23±0.40)h; t 1/2β were (9.80±3.18)and (9.71± 4.87 )h; t max were (1.45±0.28) and (1.30±0.35) h,respectively.The result of statistical analysis on above parameters showed that there was no significant difference between cyclosporine Livzon capsule and Sandimmun Neoral capsule.CONCLUSION The two formulations were bioequivalent.