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그란닥신 정(토피소팜 50 mg)에 대한 토핌 정의 생물학적 동등성
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  • 그란닥신 정(토피소팜 50 mg)에 대한 토핌 정의 생물학적 동등성
저자명
조혜영,정현철,허수희,임동구,문재동,이용복,Cho. Hea-Young,Jeong. Hyun-Cheol,Her. Su-Hi,Lim. Dong-Gu,Moon. Jai-Dong,Lee. Yong-Bok
간행물명
藥劑學會誌
권/호정보
2001년|31권 2호|pp.131-136 (6 pages)
발행정보
한국약제학회
파일정보
정기간행물|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

Tofisopam is a new type of tranquilizer valuable for the relief of anxiety and tension in a wide range of emotional disorders. Tofisopam has the therapeutic characteristics of a minor tranquilzer and a mild stimulatory effect. The purpose of the present study was to evaluate the bioequivalence of two tofisopam tablets, $Grandaxin^{TM}$ (Hwan In Pharmaceutical Co., Ltd.) and $Tofim^{TM}$ (Kyung Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, $23.11;{pm};2.83$ years in age and $65.43;{pm};7.64;kg$ in body weight, were divided into two groups and a randomized $2{ imes}2$ cross-over study was employed. After one tablet containing 50 mg of tofisopam was orally administered, blood was taken at predetermined time intervals and the concentrations of tofisopam in serum were determined using HPLC method with UV detector. 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. The results showed that the differences in $AUC_t$, C_{max};and;T_{max}$ between two tablets based on the $Grandaxin^{TM}$ were -5.59%, 2.22% and -13.18%, respectively. Minimum detectable differences $({Delta})$ at ${alpha}=0.10$ and $1-{eta}=0.8$ were less than 20% (e.g., 14.95% and 19.34% for $AUC_t;and;C_{max}$, respectively). The powers $(1-{eta})$ at ${alpha}=0.10$, ${Delta}=0.2$ for $AUC_t$ and $C_{max}$ were 95.21% and 81.93%, respectively. The 90% confidence intervals were within {pm}20%$ (e.g., $-15.64{sim}4.45$ and $-10.77{sim}15.21$ for $AUC_t;and;C_{max}$, respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that $Tofim^{TM}$ tablet is bioequivalent to $Grandaxin^{TM}$ tablet.