Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
권호 표지

Pharmacokinetic Propertiese of Entecavir 1 mg in Korean Healthy Volunteers

건강한 한국인 피험자에서 Entecavir 1 mg 제제의 약동학적 특성 평가

  • Jeon, Ji-Young (Clinical Trial Center, Chonbuk National University Hospital) ;
  • Hwang, Min-Ho (Clinical Trial Center, Chonbuk National University Hospital) ;
  • Im, Yong-Jin (Clinical Trial Center, Chonbuk National University Hospital) ;
  • Kim, Yun-Jeong (Clinical Trial Center, Chonbuk National University Hospital) ;
  • Han, Su-Mi (Clinical Trial Center, Chonbuk National University Hospital) ;
  • Im, Sung-Hyuk (Seoul Pharma Laboratories) ;
  • Chae, Soo-Wan (Clinical Trial Center, Chonbuk National University Hospital) ;
  • Kim, Min-Gul (Clinical Trial Center, Chonbuk National University Hospital)
  • 전지영 (전북대학교병원 임상시험센터) ;
  • 황민호 (전북대학교병원 임상시험센터) ;
  • 임용진 (전북대학교병원 임상시험센터) ;
  • 김윤정 (전북대학교병원 임상시험센터) ;
  • 한수미 (전북대학교병원 임상시험센터) ;
  • 임성혁 (서울의약연구소) ;
  • 채수완 (전북대학교병원 임상시험센터) ;
  • 김민걸 (전북대학교병원 임상시험센터)
  • Received : 2011.08.25
  • Accepted : 2011.09.26
  • Published : 2011.09.30
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Abstract

Entecavir is a potent and selective guanosine analogue that has demonstrated a significant antiviral efficacy against hepatitis B virus (HBV). The aim of this study was to evaluate the safety and pharmacokinetic profile after a single dose of entecavir 1 mg administration in Korean healthy male subjects. Eight volunteers were enrolled. After a single dose of 1 mg entecavir was orally administered, blood samples were collected at specific time intervals from 0-168 hours. The plasma concentrations of entecavir were determined by LC-MS/MS. The pharmacokinetic parameters were determined from the plasma concentration-time profiles. The mean values for $AUC_{last}$ and $AUC_{inf}$ were $14.84{\pm}7.81ng{\cdot}hr/mL$ and $20.71{\pm}8.80ng{\cdot}hr/mL$, respectively. The mean value for $C_{max}$ was $9.19{\pm}4.91ng/ml$ and median value for $t_{max}$ was 0.58 hr. No adverse events were reported by subjects or found on analysis of vital signs or laboratory tests. The results are suggested to be useful in clinical trials of entecavir in Korean subject including bioequivalence study.

Keywords

References

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