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세프라딘 캅셀(세프라딘 250 mg)의 생물학적 동등성
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  • 세프라딘 캅셀(세프라딘 250 mg)의 생물학적 동등성
저자명
최준식,이진환,박영진,범진필
간행물명
약학회지
권/호정보
2002년|46권 4호|pp.290-294 (5 pages)
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

Cephradine is an orally absorbed cephalosporin with a broad spectrum of activity against gram-positive and gram-negative bacteria and is highly resistant to beta-lactamase degradation. The purpose of the present study was to evaluate the bioequivalence of two cephradine capules, Cephradine capsule (Donggu Pharmaceutical Co., reference drug) and Cephradine capsule (Shinpoong Pharmaceutical Co., test drug), according to the guidelines of Korea Food and Drug Administration. Twenty-six normal volunteers, 24.6 $pm$ 3.70 years in age and 62.4 $pm$ 8.99 kg in body weight, were divided into two groups and a randomized 2 $ imes$ 2 cross-over study was employed. After one capsule containing 250 mg of cephrdine was orally administered, blood was taken at predetermined time intervals and the concentrations of cephrdine in serum were determined using HPLC with UV detector. The pharmacokinetic parameters such as AU $C_{t}$ to $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in AUCt, $C_{max}$ and $T_{max}$ between two products were 2.89%, 1.05% and 1.06%, respectively, when calculated against the reference drug. The 90% confidence intervals were within log0.8 $leq$ $delta$ $leq$ log1.25 (e.g., log0.9803 $leq$ $delta$ $leq$ log1.0734 and log0.9674 $leq$ $delta$ $leq$ log1.220 for AU $C_{t}$, and $C_{max}$, respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that Cephradine capsules (Shinpoong Pharmaceutical Co.) is bioequivalent to Cephradine capsules (Donggu Pharmaceutical Co.).o.).o.).).o.).