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치옥타시드 에이취알 정(치옥트산 600 mg)에 대한 대원치옥트산 에이취알 정 600 mg의 생물학적 동등성
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  • 치옥타시드 에이취알 정(치옥트산 600 mg)에 대한 대원치옥트산 에이취알 정 600 mg의 생물학적 동등성
저자명
강일모,이헌우,이현수,서지형,류주희,김용원,김성수,조성희,이경태,Kang. Il-Mo,Lee. Heon-Woo,Lee. Hyun-Soo,Seo. Ji-Hyung,Ryu. Ju-Hee,Kim. Yong-Won,Kim. Sung-Su
간행물명
藥劑學會誌
권/호정보
2006년|36권 6호|pp.413-419 (7 pages)
발행정보
한국약제학회
파일정보
정기간행물|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
서지반출

기타언어초록

In this study, the main purpose was to evaluate the bioequivalence of two thioctic acid tablests, Thioctacid HR tablet(Bukwang Pharm. Co., Ltd.) and Daewon thioctic acid HR tablet 600 mg(Daewon Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration(KFDA). Twenty-four, healthy Korean volunteers were divided into two groups, randomized and treated by $2{ imes}2$ crossover study. After the administration of one thioctic acid tablet containing 600 mg thioctic acid, blood samples were taken until 8 hr after the oral administration. LC-MS/MS was applied to determination of thioctic acid, and we calculated the $AUC_t,;C_{max},;T_{max}$ from the plasma concentration-time data. Analysis of variance(ANOVA) was carried out using logarithmically transformed $AUC_t;and;C_{max}$. 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 Daewon thioctic acid tablet 600 mg/Thioctacid HR were log 0.9877$sim$log 1.1938 and log 0.8169$sim$log 1.2237, respectively. These values were within the acceptable bioequivalence intervals of log 0.80$sim$log 1.25, recommended by KFDA. In all of these results we concluded that Daewon thioctic acid tablet 600 mg was bioequivalent to Thioctacid HR tablet, in terms of rate and extent of absorption.