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Cyclosporine(CyA) is a neutral, hydrophobic cyclic endecapeptide that has very potent immunosuppressive activity and used to prevent graft rejection and to treat autoimmune diseases. Cyclosporine is absorbed slowly and incompletely from the upper small bowel and pharmacokinetic parameters has variability depends on pharmaceutical formulation. For these reasons, pharmacokinetic evaluation of newly formulated cyclosporine is necessary to safe and rational application after transplantation. In this study, the bioequivalence in cyclosporine between the Sandimmun^(R)(SandozCo.) and Implanta^(R)(Hanmi pharma. Co.) Soft capsule was done, 14 normal volunteers(age 19 to 24 YO, 12 healthy males and 2 females) was divided into two groups, and a randomized, cross-over study was employed. Cycolosporine pharmacokinetic parameters(Cmax, Tmax, AUC) were evaluated and ANOVA was utilized for the stastical analysis in parameters, after 400㎎ of oral administration of each formulation. Cmax is 1162±350ng/㎖(C.V30%) in Sandimmun^(R)and 893±174ng/㎖(C.V 19.4%) in Implanta^(R), Tmax is 2.46±0.93hr(C.V37.8%) and 2.71±0.61hr(C.V 22.5%), and AUC is 6126±1591ng.hr/㎖(C.V 25.9%) and5594±1085ng.hr/㎖(C.V 19.4%), respectively. As the result of the data, Implanta of Hanmi has a slower absorption rate than Sndimmun of Sandos, but they are equal in the quantity of absorption. Cmax is lower, and Tmax is later in Implanta than in Sandimmun because of the slower absorption of Implanta. And these can be a considerable difference statistically, but these are no actual problem at a clinical standpoint. Conversely, the lower CV in these parameters in every individual can be a merit.
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