Bioequivalence of Terasin Tablet to Hytrine Tablet (Terazosin 2 mg)

하이트린 정(테라조신 2 mg)에 대한 테라신 정의 생물학적 동등성

Bioequivalence of two terazosin tablets, the $Hytrine^{TM}$ (Il-Yang Pharmaceutical Co., Ltd.) and the $Hytrine^{TM}$ (Daewon Pharmaceutical Co., Ltd.), was evaluated according to the guideline of KFDA. Sixteen normal male volunteers $(21{\sim}30\;years\;old)$ were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 2 mg of terazosin was orally administered, blood was taken at predetermined time intervals and the concentration of terazosin in serum was determined with a HPLC method using spectrofluorometric detector. The pharmacokinetic parameters $(AUC_t,\;C_{max}\;and\;T_{max})$ were calculated and ANOVA 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 were 6.02%,3.44% and -3.67%, respectively. The powers $(1-{\beta})$ for $AUC_t$, $C_{max}$ and $T_{max}$ were 98.05%, 98.34% and 29.81 %, respectively. Detectable differences $({\Delta})$ and confidence intervals were all less than ${\pm}20%$ except $T_{max}$. $AUC_t$ and $C_{max}$ met the criteria of KFDA for bioequivalence, indicating that $Terasin^{TM}$ tablet is bioequivalent to $Hytrine^{TM}$ tablet.