세파클러 250mg 캅셀의 생물학적 동등성

Abstract

This study was carried out to compare the bioavailability of Ceclex (test drug, cefaclor 250 mg/capsule) with that of Ceclor (reference drug) and to estimate the pharmacokinetic parameters of cefaclor in healthy Korean adult. The bioavailability was examined on 20 healthy volunteers who received a single dose (250 mg) of each drug in the fasting state in a randomized balanced 2-way crossover design. After dosing, blood samples were collected for a period of 6 hours. Plasma concentrations of cefaclor were determined using HPLC with UV detection. The pharmacokinetic parameters (AUC0-6hr, Cmax, Tmax, AUCinf, Ke, t1/2, Vd/F, and CL/F) were calculated with non-compartmental pharmacokinetic analysis. The ANOVA test was utilized for the statistical analysis of the Tmax, log-transformed AUC0-6hr, log-transformed Cmax, t1/2, Vd/F, and CL/F. The ratios of geometric means of AUC0-6hr and Cmax between test drug and reference drug were 103.2% (6.74 g • hr/ml vs 6.53±g • hr/ml) and 100.4% (4.85 g/ml vs 4.82 g/ml), respectively. The Tmax of test drug and reference drug were 0.9±0.38 hr and 0.83±0.34 hrs, respectively. The 90% confidence intervals of mean difference of logarithmic transformed AUC0-6hr and Cmax were log 0.98~log 1.08 and log 0.88~log1.15, respectively. It shows that the bioavailability of test drug is equivalent with that of reference drug. The estimated half-life of this study was longer (1.21±0.27 hrs vs 0.5-1 hr), the Vd/F was larger (68.89±25.72 L vs 24.9 L), and the CL/F was higher (38.62±7.09 L/hr vs 24.9 L/hr) than the previously reported values.