Bioequivalence of $Ersteine^{TM}$ Capsule to $Erdos^{TM}$ Capsule(Erdosteine 300 mg)

  • Published : 2003.10.01

Abstract

The purpose of the present study was to evaluate the bioequivalence of two Erdosteine capsules, $Erdos^{TM}$(Dae Woong Pharmaceutical Co., Ltd.) and $Ersteine^{TM}$(Dae Won Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four normal male volunteers,23.88 ${\pm}$2.89 year in age and 68.50 ${\pm}$ 7.71 kg in body weight, were divided into two groups and radkomied 2${\times}$2 cross-over study was empolyed. Ater three capsules containing 300 mg of erdosteine per capsule were orally administered, blood was taken at predetermined time intervals and concentrations of erdostene I in plasma were determined using HPLC. (omitted)

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