Bioequivalence of $Enalacc^{TM}$ Tablet to $Renitec^{TM}$ Tablet(Enalapril maleate 10 mg)

  • Cho, Sung-Hee (College of Pharmacy, Kyung Hee University) ;
  • Ha, Yong-Hwa (Medical Center, Kyung Hee University) ;
  • Hong, Sung-Je (Bioanalysis and Biotransformation Research Center, KIS) ;
  • Seo, Seong-Hoon (Bioanalysis and Biotransformation Research Center, KIS) ;
  • Rew, Jae-Hwan (Bioanalysis and Biotransformation Research Center, KIS) ;
  • Kim, Dong-Hyun (Bioanalysis and Biotransformation Research Center, KIS) ;
  • Lee, Kyung-Tae (Bioanalysis and Biotransformation Research Center, KIST)
  • Published : 2003.10.01

Abstract

ABSTRACT-The purpose of the present study was to evaluate the bioequivalence of two enalapril maleate tablest, $Renitec^{TM}$(MSD Korea Ltd.) and $Enalace^{TM}$(Welfide Korea Ltd.), according to the guidelines of Korea Food and Drug Administration (DFDA). Twenty-four normal male volunteers, 22.33 ${\pm}$ 2.55 year in age and 66.54 ${\pm}$ 8.30 kg in body weight, were divided into two groups and a randomized 2${\times}$2 cross-over study was employed. After two tablets containing 10 mg of enalapril maleate per tablet were orally administered, blood was taken at predetermined time intervals and concentrations of enalapril in plasma were determined using LC-MS-MS. (omitted)

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