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KMID : 0941819970070010017
Korean Journal of Clinical Pharmacy
1997 Volume.7 No. 1 p.17 ~ p.21
Bioequivalence of Cefaclor Capsules Following Single Dose Administration to Healthy Male Volunteers
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Abstract
Cefaclor is a second generation cephalosporin antibiotic that shows a potent antibacterial activity against both Gram-positive and Gram-negative bacteria, when it is orally administered. Due to its patent expiration, a number of generic drugs have been marketed, but not yet elucidated to ensure therapeutic equivalence. In this study, cefaclor capsules manufactured by Chong Kun Dang were bioequivallently assessed by comparing with Ceclor^{TM} introduced originally by Daewoong Lilly. A total of 16 healthy male volunteers were evaluated in a randomized crossover manner with a 2-week washout period. Concentrations of cefaclor in plasma were measured upto 6 hours following a single oral administration of two capsules (500 mg of cefaclor) by high-performance liquid chromatography with UV detection. Although the plasma concentration at 6 hours was not detected, the computed half-life of cefaclor was approximately 0.5 hours. The area under the concentration-vs-time curve from 0 to 4 hours (AUC_{0-4h}) was calculated by the trapezoidal summation method. The differences in mean values of AUC_{0-4h}, peak plasma concentration (C_{max}), and time to peak concentration (T_{max}) between the two products were 4.63%,;1.84%,;and3.28%, respectively. The least significant differences at alpha4= 0.05 for AUC_{0-4h},;C_{max},;and;T_{max};were;6,53%,;4.05%,;and;6.47%, respectively. In conclusion, the test drug was bioequivalent with the reference drug.
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