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KMID : 0941820030130010013
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Korean Journal of Clinical Pharmacy
2003 Volume.13 No. 1 p.13 ~ p.17
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Bioequivalence of Cefaclor 375 mg SR Tablet
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Lee Shin-Hwa
Yun Min-Hyuk
Choi Kyung-Eob
Kwon Kwang-II
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Abstract
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This study was carried out to compare the bioavailability of Ceclex^{(R)} SR TAB (test drug, cefaclor 375 mg/Tablet) with that of Ceclor MR^{(R)} SR IAB (reference drug) and to estimate the pharmacokinetic parameters of cefaclor in healthy Korean volunteers. The bioavailability was examined on 24 healthy volunteers who received a single dose (375 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 7 hours. Plasma concentrations of cefaclor were determined using HPLC with UV detection. The pharmacokinetic parameters (AUC_{0-7h},;C_{max},;T_{max},;AUC_{inf},;K_e,;t_{1/2},;V_d/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_{0-7h}, log-transformed C_{max},;t_{1/2},;V_d/F, and CL/F. The ratios of geometric means of AUC_{0-7h};and;C_{max} between test drug End reference drug were 95.67%;(8.55;vs;8.18{mu}g{cdot}hr/ml);and;103.86%;(2.85;vs;2.96{mu}g/ml), respectively. The T_{max} of test drug and reference drug was 2.56pm0.15;and;2.23pm0.13;hrs,;respectively.;The;90% confidence intervals of mean difference of logarithmic transformed AUC_{0-7h};and;C_{max} were log0.90-log1.04 and log0.91-log1.13, respectively. It shows that the bioavailability of test drug is equivalent with that of reference drug.
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KEYWORD
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Cefaclor extended-release, Bioequivalence, Pharmacokinetics, Korean
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