earticle

영어

This study was carried out to compare the bioavailability of (test drug, cefaclor 250 mg/capsule) with that of (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 6hours. Plasma concentrations of cefaclor were determined using HPLC with UV detection. The pharmacokinetic parameters F, and CL/F) were calculated with non-compartmental pharmacokinetic analysis. The ANOVA test was utilized for the statistical analysis of the , and CL/F. The ratios of geometric means of AUC0-6hr and between test drug and reference drug were , respectively. The of test drug and reference drug were hrs, respectively. The confidence intervals of mean difference of logarithmic transformed were log 1.08 and log , 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 , the Vd/F was larger vs 24.9L), and the CL/F was higher vs 24.9 L/hr) than the previously reported values.