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디스그렌 캅셀(트리플루살 300 mg)에 대한 티그린 캅셀의 생물학적 동등성
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  • 디스그렌 캅셀(트리플루살 300 mg)에 대한 티그린 캅셀의 생물학적 동등성
저자명
김수진,심영순,손선미,임동구,문재동,이용복,Kim. Soo-Jin,Shim. Young-Sun,Son. Sun-Mi,Lim. Dong-Koo,Moon. Jai-Dong,Lee. Yong-Bok
간행물명
藥劑學會誌
권/호정보
1999년|29권 4호|pp.355-360 (6 pages)
발행정보
한국약제학회
파일정보
정기간행물|
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기타
이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

Triflusal is a new antithrombotic agent which inhibits both platelet cyclooxygenase and c-AMP phosphodiesterase activity. The purpose of the present study was to evaluate the bioequivalence of two triflusal capsules, $Disgren^{TM}$ (Myung-In Pharmaceutical Co., Ltd.) and $Tigriri^{TM}$ (Hana Pharmaceutical Co., Ltd.) according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, $22.94{pm}1.83$ in age and $63.7l{pm}10.43$ kg in body weight, were divided into two groups and a randomized $2{ imes}2$ cross-over study was employed. After one capsule containing 300 mg of triflusal was orally administered, blood was taken at predetermined time intervals and the concentrations of triflusal in serum were determined using HPLC method with UV detector. 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. The results showed that the differences in $AUC_t$ $C_{max}$ and $T_{max}$ between two capsules were -0.30%, 0.81 % and -3.03%, respectively when calculated against the $Disgren_{TM}$ capsule. The powers $(1-{eta})$ for $AUC_t$ $C_{max}$ and $T_{max}$ were 98.29%,84.73% and 81.02%, respectively. Minimum detectable differences $({Delta})$ at ${alpha}=0.1$ and $1-{eta}=0.8$ were all less than 20% (e.g., 12.91%, 18.46% and 19.65% for $AUC_t$ $C_{max}$ and $T_{max}$ respectively). The 90% confid,ence intervals were all within ${pm}20%$(e.g., $-8.97{sim}8.37$, $-11.58{sim}13.22$ and $-16.23{sim}10.17$ for $AUC_t$ $C_{max}$ and $T_{max}$, respectively). All of the above parameters ($1-{eta}, {Delta}$ and 90% confidence intervals) met the criteria of KFDA for bioequivalence, indicating that $Tigriri^{TM}$ capsule is bioequivalent to $Disgren^{TM}$ capsule.