그란닥신 정(토피소팜 50 mg)에 대한 토핌 정의 생물학적 동등성

Bioequivalence of Tofim Tablet to Grandaxin Tablet (Tofisopam 50 mg)

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 $2{\times}2$ 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 $1-{\beta}=0.8$ were less than 20% (e.g., 14.95% and 19.34% for $AUC_t\;and\;C_{max}$, respectively). The powers $(1-{\beta})$ 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.