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KMID : 0370020030170000067
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Chung-Ang Journal of Pharmacal Sciences
2003 Volume.17 No. 0 p.67 ~ p.80
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Bioequivalent Test of Cypol-N 100㎎ Soft Capsule
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Abstract
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We evaluated whether Cipol-N soft capsule (Chong Kun Dang pharmaceutical Inc., Korea) and Sandimmun Neoral(soft capsule, Novartis Korea Ltd.) presented identical bioequivalence according to the guidiline of Korea Food and Drug Administration (KFDA) by pharmacokinetic study after single-dose administration.
Twenty two healthy korean male volunteers were divided into two groups randomly and 2×2 cross-over study were employed. After one capsule containing 200 mg was orally administered, blood was taken at predetermined time intervals, from before the administration to 24 hours. Followed by one-week free-drug period, the oral administration of the other kind of drug and blood sampling were performed. The concentration of cyclosporine in total blood were measured radioimmunologically. Pharmacokinetic parameters, such as AUC (Area Under Curve), Cmax (Maximum concentration in blood), and Tmax (Time to the maximuml concentration in blood), were obtained calculated to estimate their bioequvalences.
After the administration of 200 mg single-dose of Cipol-N and Sandimmun Neoral, AUC were 4855±361 ng·h/ml and 4978±357 ng·h/ml, respectively; 1162±51ng/ml and 1108±55 ng/ml in Cmax; 1.56±0.09 h and 1.67±0.12 h in Tmax. The analysis of variance showed no significant difference in two drug with 90% confidence limit, detection range (1-β) > 0.8, and minimum detection difference (δ) ≤ 0.2. The differeneces of mean of these parameters were AUC -4.06 %, Cmax 5.66 %, and Tmax -12.89 %, which indicated the differences of two drugs were less than 20%.
With these results, Cipol-N soft capsule presented identical bioequivalence with Sandimmun Neoral.
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