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듀리세프 캅셀(세파드록실 500 mg)에 대한 하나세프 캅셀의 생물학적 동등성
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  • 듀리세프 캅셀(세파드록실 500 mg)에 대한 하나세프 캅셀의 생물학적 동등성
저자명
조혜영,이석,문재동,이용복,Cho. Hea-Young,Lee. Suk,Moon. Jai-Dong,Lee. Yong-Bok
간행물명
藥劑學會誌
권/호정보
2002년|32권 2호|pp.135-140 (6 pages)
발행정보
한국약제학회
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정기간행물|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

Cefadroxil is a semi-synthetic cephalosporin active against many Gram-positive and Gram-negative bacteria. The drug has been used for the treatment of the urinary and respiratory tract infections when caused by susceptible strains of the designated microorganism. The purpose of the present study was to evaluate the bioequivalence of two cefadroxil capsules, Duricef (Bo Ryung Pharmaceutical Co. Ltd.) and Hanacef (Korean Pharmaceutical Co. Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The cefadroxil release from the two cefadroxil capsules in vitro was tested using KP VII Apparatus II method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty four normal male volunteers, $21.58{pm}2.43$ years in age and $70.74{pm}10.29$ kg in body weight, were divided into two groups and a randomized $2{ imes}2$ cross-over study was employed. After one capsule containing 500 mg as cefadroxil was orally administered, blood was taken at predetermined time intervals and the concentrations of cefadroxil in serum were determined using HPLC with UV detector. The dissolution profiles of two cefadroxil capsules were very similar at all dissolution media. The pharmacokinetic parameters such as $AUC_t,;C_{max};and;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t;and;C_{max}$ and untransformed $T_{max}$. The results showed that the differences in $AUC_t,;C_{max};and;T_{max}$ between two capsules based on the Duricef were 0.05%, -5.29% and 4.53%. There were no sequence effects between two capsules in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) $(e.g.,;log(0.95){sim}log(1.05);and;log(0.87){sim}log(1.02)$ for $AUC_t;and;C_{max}$, respectively). The 90% confidence interval using untransformed data was within ${pm}20%$ $(e.g.,;-6.75{sim}15.74;for;T_{max})$. All parameters met the criteria of KFDA guideline for bioequivalence, indicating that Hanacef capsule is bioequivalent to Duricef capsule.