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씨프로바이정 (시프로플록사신 250 mg)에 대한 로프신정의 생물학적 동등성평가
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  • 씨프로바이정 (시프로플록사신 250 mg)에 대한 로프신정의 생물학적 동등성평가
저자명
김복희,신영희,Kim. Bok-Hee,Shin. Young-Hee
간행물명
藥劑學會誌
권/호정보
2009년|39권 6호|pp.451-456 (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

The purpose of the present study was to evaluate the bioequivalence of two ciprofloxacin tablets, Ciprobay (Bayer Korea Ltd.) and Rofcin (Binex Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The release of ciprofloxacin from the two ciprofloxacin tablets in vitro was tested using KP XIII Apparatus I method with dissolution media (0.01 M HCl). The dissolution profiles of two ciprofloxacin tablets were very similar at dissolution media. Twenty four healthy male volunteers were divided into two groups and a randomized 2$2{ imes}2$2 cross-over study was employed. After one tablet (250 mg ciprofloxacin) was orally administrated, blood was taken and the concentrations of ciprofloxacin in serum were determined using HPLC with UV detector. The pharmacokinetic parameters such as $AUC_t,;C_{max};and;T_{max}$ were calculated. The results showed that the differences in $AUC_t,;C_{max};and;T_{max}$ between two ciprofloxacin tablets based on the Ciprobay were -0.63%, 3.98% and -9.23%, respectively. There were no sequence effects between two tablets in these parameter. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25)(e.g., log(0.9520)~log(1.0523) and log(0.9689)~log(1.1663) for $AUC_1;and;C_{max}$, respectively). Thus, Rofcin tablet was bioequivalent to Ciprobay tablet.