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건일로딘 정(미결정에토돌락 200 mg)에 대한 에토돌 정의 생물학적동등성

Bioequivalence of EtodolTM Tablet to KuhnillodineTM Tablet (Micronized Etodolac 200 mg)

  • 이정애 (바이오코아주식회사) ;
  • 이윤영 (바이오코아주식회사) ;
  • 조태섭 (바이오코아주식회사) ;
  • 박영준 ((주)유한양행) ;
  • 문병석 ((주)유한양행) ;
  • 김호현 (바이오코아주식회사, 서울의과학연구소) ;
  • 이예리 (바이오코아주식회사, 서울의과학연구소) ;
  • 이희주 (바이오코아주식회사, 서울의과학연구소) ;
  • 이경률 (바이오코아주식회사, 서울의과학연구소)
  • Lee, Jung-Ae (Department of Drug Development Service, BioCore Co., Ltd.) ;
  • Lee, Yun-Young (Department of Drug Development Service, BioCore Co., Ltd.) ;
  • Cho, Tae-Seob (Department of Drug Development Service, BioCore Co., Ltd.) ;
  • Park, Young-Joon (Yuhan Corporation) ;
  • Moon, Byoung-Seok (Yuhan Corporation) ;
  • Kim, Ho-Hyun (Department of Drug Development Service, BioCore Co., Ltd., Department of Pharmacokinetics, Seoul Medical Science Institute, Seoul Clinical Laboratories) ;
  • Lee, Ye-Rie (Department of Drug Development Service, BioCore Co., Ltd., Department of Pharmacokinetics, Seoul Medical Science Institute, Seoul Clinical Laboratories) ;
  • Lee, Hee-Joo (Department of Drug Development Service, BioCore Co., Ltd., Department of Pharmacokinetics, Seoul Medical Science Institute, Seoul Clinical Laboratories) ;
  • Lee, Kyung-Ryul (Department of Drug Development Service, BioCore Co., Ltd., Department of Pharmacokinetics, Seoul Medical Science Institute, Seoul Clinical Laboratories)
  • 발행 : 2004.08.20

초록

A bioequivalence of $Etodol^{TM}$ tablets (Yuhan corporation) and $Kuhnillodine^{TM}$ tablets (Kuhnil Pharm. Co., Ltd.) was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Single 200 mg dose of etodolac of each medicine was administered orally to 24 healthy male volunteers. This study was performed in a $2{\times}2$ crossover design. Concentrations of etodolac in human plasma were monitored by a high-performance liquid chromatography. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 24 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was performed using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Etodol^{TM}/Kuhnillodine^{TM}$ were 1.01-1.10 and 0.87-1.06, respectively. This study demonstrated a bioequivalence of $Etodol^{TM}$ and $Kuhnillodine^{TM}$ with respect to the rate and extent of absorption.

키워드

참고문헌

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