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KMID : 0369820050350030187
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Jorunal of Korean Pharmaceutical Sciences
2005 Volume.35 No. 3 p.187 ~ p.192
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Bioequivalence of Benipine Tablet to Codipine Tablet (Benidipine Hydrochloride 4mg)
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박완수/Park WS
조성희/이헌우/임호택/류재환/이미진/김동현/이경태/Cho SH/Lee HW/Im HT/Rew JH/Lee MJ/Kim DH/Lee KT
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Abstract
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The purpose of the present study was designed to evaluate the bioequivalence of two benidipine hydrochloride tablets, Codipine (Youngjin Pharm. Co., Ltd.) and Benipine (Myungmoon Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four normal male volunteers, 23.00±1.82 year in age and 70.08±9.59 kg in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After two tablets containing 4 mg of benidipine hydrochloride were orally administered, blood was taken at predetermined time intervals and concentrations of benidipine in plasma were determined using LC-MS/MS. Pharmacokinetic parameters such as AUCt, Cmax and Tmax were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed AUCt, and Cmax. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals for the log transformed data were acceptance range of log0.8 to log1.25 (e.g.,log1.04∼log1.24andlog0.91∼log1.09 for AUCt, and Cmax respectively). The major parameters, AUCt and Cmax, met the criteria of KDFA for bioequivalence indicating that Benipine tablet is bioequivalent to Codipine tablet.
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KEYWORD
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Benidipine, Codipine, Benipine, Bioequivalence, LC-MS/MS
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