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KMID : 0369820060360060413
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Jorunal of Korean Pharmaceutical Sciences
2006 Volume.36 No. 6 p.413 ~ p.419
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Bioequivalence of Thioct Acid HR Tablet to Daewon Thioctic Acid HR Tablet 600mg (Thoctic Acid 600 mg)
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Kang Il-Mo
Lee Heon-Woo
Lee Hyun-Soo
Seo Ji-Hyung
Ryu Ju-Hee
Kim Yong-Won
Kim Sung-Su
Cho Sung-Hee
Lee Kyung-Tae
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Abstract
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In this study, the main purpose was to evaluate the bioequivalence of two thioctic acid tablets, Thioctacid HR tablet (Bukwang Pharm. Co., Ltd.) and Daewon thioctic acid HR tablet 600 mg(Daewon Pharm. Co., Ltd), according to the guidekines of Korea Food and Drug Administration(KFDA). Twenty-four healthy Korean volunteers were divided into two groups, randomized and treated by 2×2 crossover study. After the administration of on tioctic acid tablet containing 600mg 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 caculated the AUCt, Cmax, Tmax from the plasma concetration-time data. Analysis of variance(ANOVA) was carried out using logarithmically transformed AUCt and Cmax. 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 AUCt ratio and the Cmax ratio for Daewon thioctic acid tablet 600mg/Thioctacid HR were log 0.9877~log 1.1938 and log 0.8169~log 1.2237, respectively. These values were within the acceptable bioequivalence intervals of log 0.80~log 1.25, recommended by KFDA. In all of these results, we concluded that Daewon thioctic acid tablet 600 mg was bioequivalent to Tioctacid HR tablet, in term of rate and extent of absorption.
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KEYWORD
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Thioct acid, LC-MS/MS, Bioequivalence
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