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KMID : 0941819980080010019
Korean Journal of Clinical Pharmacy
1998 Volume.8 No. 1 p.19 ~ p.22
Bioequivalency on the Comparative Bioavailability of Two Capsule Formulations of Cefixime in Human Volunteers



Abstract
Cefixime is an orally absorbed 3rd generation cephalosporin with a broad spectrum of activity against Gram-positive and Gram-negative bacteria and is highly resistant to beta-lactamase degradation. This study was carried out to evaluate the bioavailability of a new test drug of cefixime (100 mg/capsule) relative to the reference drug. The bioavailability was conducted on 20 healthy volunteers who received a single dose (400 mg) of the test and the reference drugs in the fasting state, in a randomized balanced 2-way crossover design. After dosing, serial blood samples were collected for a period of 12 hours. Plasma was analyzed for cefixime by a sensitive and validated HPLC assay. The major pharmacokinetic parameters (AUC_{0-12hr},;C_{max},;T_{max}) were calculated from the plasma concentration-time data of each volunteer. The AUC_{0-12hr},;C_{max};and;T_{max} of the test drug were 36.91pm11.85;{mu}g{cdot}hr/ml,;5.47pm1.61;{mu}g/ml,;and;4.00pm0.65;hr, respectively, and those of the reference drug were 34.08pm8.81;{mu}g{cdot}hr/ml,;5.25pm1.40;{mu}g/ml,;and;4.20pm0.62;hr, respectively. Mean differences of those parameters were 8.32, 4.29, and 4.76%, respectively, and the least significant differences at alpha=0.05 for AUC_{0-12hr},;C_{max},;T_{max} were 16.02, 13.78, and 11.76%, respectively. In conclusion, the test drug was bioequivalent with the reference drug.
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