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KMID : 0369820090390020141
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Jorunal of Korean Pharmaceutical Sciences
2009 Volume.39 No. 2 p.141 ~ p.147
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Bioequivalence of Tablet to Tablet (nateglinide 90 mg)
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Tak Sung-Kwon
Lee Jin-Sung
Choi Sang-Jun
Seo Ji-Hyung
Lee Myung-Jae
Kang Jong-Min
Ryu Ju-Hee
Hong Seung-Jae
Yim Sung-Vin
Lee Kyung-Tae
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Abstract
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The purpose of this study was to evaluate the bioequivalence of two nateglinide tablets, tablet (ILDONG Pharm. Co., Ltd., Seoul, Korea, reference drug) and tablet (ILHWA. Co., Ltd., Seoul, Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Thirty-five healthy male volunteers, years in age and in body weight, were divided into two groups and a randomized cross-over study was employed. After a tablet containing 90 mg of nateglinide was orally administrated, blood was taken at predetermined time intervals over a period of 8 hr and concentrations of nateglinide in plasma were monitored using LC-MS/MS. Pharmacokinetic parameters such as AUCt (the area under the plasma concentration-time curve from time 0 to 8 hr), (maximum plasma drug concentration) and (time to reach ) were calculated and analysis of variance (ANOVA) test was utilized for the statistical analysis of the parameters using logarithmically transformed and and untransformed . The 90% confidence intervals of the ratio and the ratio for were and , respectively. Since these values were within the acceptable bioequivalence intervals of , recommended by KFDA, it was concluded that tablet was bioequivalent to tablet, in terms of both rate and extent of absorption.
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KEYWORD
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Nateglinide, LC-MS/MS, Bioequivalence
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