초록
The bioequivalence of two cyclosporin A products was evaluated in 26 normal male volunteers (age 25 ~33 yr, body weight 56~84 kg) following single oral administration. Test product was a hard capsule containing the granule of cyclosporin A (Chong Kun Dang Corp., Korea) and reference product, Sandimmun", was a soft capsule containing surfactant, oil, alcohol and cyclosporin A (Sandoz, Swiss). Both products contain 100 mg of cyclosporin A. Four capsules of the test and the reference product were administered to the volunteers, respectively, by randomized two period cross-over study (2$\times$2 Latin square method). Average drug concentrations at each sampling time and pharmacokinetic parameters were not significantly different between two products (p>0.05); the area under the concentration-time curve to last sampling time (24 hr) (AU $Co_{24}$) (5034.8$\pm$ 1760.6 vs 4635.4$\pm$ 1158.9 ng . h/ml), maximum plasma concentration ( $C_{max}$) (1002.7$\pm$353.1 vs 980. 4$\pm$ 171.7 ng/71), and mean residence time (MRT) (6.16$\pm$0.81 vs 5.64$\pm$0.50 h). The differences of mean AUC 7-,4,7~, T_ and MRT between the two products (7.93,2.22,16 and 8.39%, respectively) were less than 20% given as a guideline. The power (1-$\beta$) and treatment difference ($\Delta$) for AU $Co_{24}$, $C_{max}$ and MRT were more than 0.8 and less than 0.2, respectively. Although $T_{max}$ of the two products was significantly different each other (p<0.05), $T_{max}$ might be an insignificant parameter because cyclosporin A generally requires long-term administration. From these results, the two products are bioequivalent.alent.t.
