개선된 HPLC분석법을 이용한 세파클러 모노하이드레이트 250 mg 캡슐의 생물학적동등성

Abstract

A bioequivalence study of CKD Cefaclor ??capsule (Chong Kun Dang Pharm. Co., Ltd) to Ceclor??capsule (LillyKorea. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the cefaclor dose of 250 mg in a 2×2 crossover study. There was a one-week washout period between the doses. An improved high-performance liquid chromatography (HPLC) analytical method with UV detection was used to determine plasma cefaclor concentration in human volunteers for 8 hr after oral drug administration. The area under the plasma concentration-time curve from time zero to 8 hr (AUC0-8hr) was calculated by the linear trapezoidal rule. The Cmax (maximum plasma drug concentration) and Tmax (time to reach Cmax) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed AUC0-8hr and Cmax. No significant sequence effect was found for all of the bioavailability parameters indicating that the cross-over design was properly performed. The 90% confidence intervals of the AUC0-8hr ratio and the Cmax ratio for CKD Cefaclor ??and Ceclor?? were 0.9400≤δ≤1.0345 and 0.8858≤δ≤1.1021,respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstratedthe of CKD cefaclor??capsule was bioequivalent to Ceclor??capsule with respect to its bioavailability.