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This study was carried out to compare the bioavailability of Ceclex^{(R)} (test drug, cefaclor 250 mg/capsule) with that of Ceclor^{(R)} (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 (AUC_{0-6hr},;C_{max},;T_{max},;AUC_{int},;K_e,;t_{1/2},;Vd) F, and CL/F) were calculated with non-compartmental pharmacokinetic analysis. The ANOVA test was utilized for the statistical analysis of the T_{max},;log-transformed;AUC_{0-6hr};log-transformed;C_{max},;t_{l/2},;V_d/F, and CL/F. The ratios of geometric means of AUC0-6hr and C_{max} between test drug and reference drug were 103.2%;(6.74;{mu}g{cdot}hr/ml;vs;6.53{pm}g{cdot}hr/ml);and;100.4%;(4.85;{mu}gml;vs;4.82;{mu}g/ml), respectively. The T_{max} of test drug and reference drug were 0.9pm0.38;hr;and;0.83pm0.34 hrs, respectively. The 90% confidence intervals of mean difference of logarithmic transformed AUC_{0-6h},;and;C_{max} were log 0.98{sim}log 1.08 and log 0.88{sim}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 (1.21pm0.27;hrs;vs;0.5-1;hr), the Vd/F was larger (68.89pm25.72L vs 24.9L), and the CL/F was higher (38.62pm7.09;L/hr vs 24.9 L/hr) than the previously reported values.
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