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세파클러 캅셀제에 대한 생물학적 동등성 평가
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  • 세파클러 캅셀제에 대한 생물학적 동등성 평가
  • Bioequivalence of Cefaclor Capsules Following Single Dose Administration to Healthy Male Volunteers
저자명
복혜숙,김명민,권이오,최경업,Bok. Hae Sook,Kim. Myoung Min,Kwon. Yi Oh,Choi. Kyung Eob
간행물명
한국임상약학회지
권/호정보
1997년|7권 1호|pp.17-21 (5 pages)
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한국임상약학회
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

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.