초록
The purpose of the present study was to evaluate the bioequivalence of tamsulosin HCl capsule, $Harnal^{\circledR}$(Jeil Korea Ltd.) and $Yutanal^{\circledR}$(Kukje Korea Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four normal male volunteers, $23.29{\pm}2.14$ year in age and $72.08{\pm}7.83$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one capsule containing 0.2 mg of tamsulosin HCl were orally administered, blood was taken at predetermined time intervals and concentrations of tamsulosin in plasma were determined using LC-MS/MS. Pharmacokinetic parameters such as $AUC_t$, $T_{max}$ and $C_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals for the log transformed data were acceptance range of log0.8 to log1.25 (e.g., $log0.93{\sim}log1.11$ and $log0.80{\sim}log0.94$ for $AUC_t$, and $C_{max}$, respectively). The major parameters, $AUC_t$, and $C_{max}$, met the criteria of KFDA for bioequivalence indicating that $Yutanal^{\circledR}$ capsule is bioequivalent to $Harnal^{\circledR}$ capsule.
