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타리비드 정(오플록사신 100 mg)에 대한 파비드 정의 생물학적동등성
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  • 타리비드 정(오플록사신 100 mg)에 대한 파비드 정의 생물학적동등성
저자명
박완수,조성희,이헌우,임호택,홍성제,서성훈,류재환,이경태,Park. Wan-Su,Cho. Sung-Hee,Lee. Heon-Woo,Im. Ho-Taek,Hong. Seong-Je,Seo. Seong-Hoon,Rew. Jae-Hwa
간행물명
藥劑學會誌
권/호정보
2005년|35권 1호|pp.45-50 (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 designed to evaluate the bioequivalence of two ofloxacin tablets, Tarivid (Jeil Pharm. Co., Ltd.) and Favid (ILHWA Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four normal male volunteers, $23.67{pm}3.12$ year in age and $68.50{pm}7.23$ kg in body weight, were divided into two groups and a randomized $2{ imes}2$ cross-over study was employed. After four tablets containing 100 mg of ofloxacin were orally administered, blood was taken at predetermined time intervals and concentrations of ofloxacin in plasma were determined using HPLC. 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 $T_{max}$. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals for the log transformed data were acceptance range of log 0.8 to log 1.25 (e.g., $log0.94{sim}log1.04;and;log0.90{sim}log1.07;for;AUC_t;and;C_{max}$, respectively). The major parameters, $AUC_t$, and $C_{max}$, met the criteria of KDFA for bioequivalence indicating that Favid tablet is bioequivalent to Tarivid tablet.