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프레탈 정(시로스타졸 50 mg)에 대한 로사졸 정의 생물학적 동등성
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  • 프레탈 정(시로스타졸 50 mg)에 대한 로사졸 정의 생물학적 동등성
저자명
김수진,임동구,오인준,조행남,서순팔,이용복,Kim. Soo-Jin,Lim. Dong-Koo,Oh. In-Joon,Cho. Haeng-Nam,Suh. Soon-Pal,Lee. Yong-Bok
간행물명
藥劑學會誌
권/호정보
1998년|28권 3호|pp.193-198 (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

Bioequivalence of two cilostazol tablets, the $Pletaal^{TM}$ (Korea Otsuka Pharmaceutical Co., Ltd.) and the $Losazol^{TM}$ (Kyoung Dong Pharmaceutical Co., Ltd.), was evaluated according to the guideline of KFDA. Fourteen normal male volunteers (age $20{sim}28$ years old) were divided into two groups and a randomized $2{ imes}2$ cross-over study was employed. After two tablets containing 50 mg of cilostazol were orally administered, blood was taken at predetermined time intervals and the concentration of cilostazol in plasma was determined with an HPLC method using UV detector. The pharmacokinetic parameters $(C_{max},;T_{max};and;AUC_t)$ were calculated and ANOVA was utilized for the statistical analysis of parameters. The results showed that the differences in $C_{max},;T_{max};and;AUC_t$ between two tablets were 3.14%, 10.0% and 7.35%, respectively. The powers $(1-{eta})$ for $C_{max},;T_{max};and;AUC_t$ were 89.67%, 80.97% and 83.87%, respectively. Detectable differences $({Delta})$ and confidence intervals were all less than 20% except $T-{max}$, but confidence interval of $T_{max}$ was also less than 20% at the significance $level({alpha})$ of 0.1. All of these parameters met the criteria of KFDA for bioequivalence, indicating that $Losazol^{TM}$ tablet is bioequivalent to $Pletaal^{TM} tablet$.