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서지반출
하루날® 캡슐(염산 탐스로신, 0.2 mg)에 대한 유타날® 캡슐의 생물학적동등성
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  • 하루날® 캡슐(염산 탐스로신, 0.2 mg)에 대한 유타날® 캡슐의 생물학적동등성
저자명
임호택,조성희,이헌우,박완수,김영관,류재환,이경태,Im. Ho-Taek,Cho. Sung-Hee,Lee. Heon-Woo,Park. Wan-Su,Kim. Young-Kwan,Rew. Jae-Hwan,Lee. Kyung-Tae
간행물명
藥劑學會誌
권/호정보
2005년|35권 4호|pp.309-315 (7 pages)
발행정보
한국약제학회
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정기간행물|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

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 $2{ imes}2$ 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.