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지원자의 Cefixime캅셀제 생체이용율에 대한 생물학적동등성 연구
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  • 지원자의 Cefixime캅셀제 생체이용율에 대한 생물학적동등성 연구
  • Bioequivalency on the Comparative Bioavailability of Two Capsule Formulations of Cefixime in Human Volunteers
저자명
강원구,우종수,권광일,Kang. Won Ku,Woo. Jong Su,Kwon. Kwang Il
간행물명
한국임상약학회지
권/호정보
1998년|8권 1호|pp.19-22 (4 pages)
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한국임상약학회
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

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 $eta-lactamase$ 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.