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소말겐 정(탈니플루메이트 370 mg)에 대한 플루탈 정의 생물학적동등성
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  • 소말겐 정(탈니플루메이트 370 mg)에 대한 플루탈 정의 생물학적동등성
저자명
이헌우,조성희,박완수,임호택,김영관,류재환,이경태,Lee. Heon-Woo,Cho. Sung-Hee,Park. Wan-Su,Im. Ho-Taek,Kim. Young-Kwan,Rew. Jae-Hwan,Lee. Kyung-Tae
간행물명
藥劑學會誌
권/호정보
2005년|35권 4호|pp.303-308 (6 pages)
발행정보
한국약제학회
파일정보
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 two talniflumate tablets, SOMALGEN tablet (Kun Wha Pharm. Co., Ltd., Seoul, Korea, reference drug) and FLUTAL tablet (Kukje Pharm. Co., Ltd., Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received two tablets at the talniflumate dose of 740 mg in a $2{pm}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of niflumic acid were monitored by an HPLC-UV for over a period of 14 hr after the administration. $AUC_t$(the area under the plasma concentration-time curve from time zero to 14 hr) was calculated by the linear trapezoidal rule method. $C_{max}$(maximum plasma drug concentration) and $T_{max}$(time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$, ratio and the $C_{max}$ ratio for SOMALGEN/FLUTAL were $log0.8510{sim}log1.0318$ and $log0.9264{sim}log1.0607$, respectively. These values were within the acceptable bioequivalence intervals of $log0.80{sim}log1.25$. Taken together, our study demonstrated the bioequivalence of SOMALGEN and FLUTAL with respect to the rate and extent of absorption.