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KMID : 0369820060360010059
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Jorunal of Korean Pharmaceutical Sciences
2006 Volume.36 No. 1 p.59 ~ p.65
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Bioequivalence of A-PINE Tablet to SKAD Tablet (Amlodipine Maleate 6.42 mg)
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김성수/Kim SS
박완수/이헌우/서지형/김용원/조성희/류재환/이경태/Park WS/Lee HW/Seo JH/Kim YW/Cho SH/Rew JH/Lee KT
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Abstract
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The purpose of this study was to evaluate the bioequivalence of two amlodipine maleate tablets, SKAD tablet (SK Pharma. Co., Ltd., Seoul, Korea, reference drug) and A-PINE tablet (Daewon Pharm. Co., Ltd., Seoul, Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four healthy male volunteers, 22.79±1.86 years in age and 70.08±8.68 kg in body weight, were divided into two groups and a randomized 2\time2 crossover study was employed. After a tablet containing 6.42 mg of amlodipine maleate was orally administrated, blood was taken at predetermined time intervals over a period of 144 hr and concentrations of amlodipine in plasma were monitored using LC-MS/MS. Pharmacokinetic parameters such as AUCt (the area under the plasma concentration-time curve from time zero to 144 hr), Cmax (maximum plasma drug concentration) and Tmax (time to reach Cmax) were calculated and analysis of variance (ANOVA) test was utilized for the statistical analysis of the parameters using logarithmically transformed AUCt and Cmax, and untransformed Tmax. 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 A-PINE/SKAD were log0.9429∼log1.1476 and log0.9l46∼log1.1488, respectively. Since these values were within the acceptable bioequivalence intervals of log0.80∼log1.25, recommended by KFDA, it was concluded that A-PINE tablet was bioequivalent to SKAD tablet, in terms of both rate and extent of absorption.
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KEYWORD
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Amlodipine maleate, LC-MS/MS, Bioequivalence
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