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서지반출
Bioequivalence Assessment of Domperidone Maleate Tablets in Healthy Korean Volunteers
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  • Bioequivalence Assessment of Domperidone Maleate Tablets in Healthy Korean Volunteers
  • Bioequivalence Assessment of Domperidone Maleate Tablets in Healthy Korean Volunteers
저자명
Kim. Sung-Chull,Lee. Jun-Woo,Yoo. An-Na,Chang. Hyun-Sung,Lee. Kyung-Hee,Park. Jong-Min,Nam. Doo-Hyun
간행물명
The journal of applied pharmacology : the official journal of the Korean Society of Applied Pharmacology
권/호정보
2003년|11권 2호|pp.145-150 (6 pages)
발행정보
한국응용약물학회
파일정보
정기간행물|ENG|
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기타
이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
서지반출

기타언어초록

The bioequivalence of two tablet formulations of 12.72mg domperidone maleate (Sinil "$Perinal^{circledR}$" tablets vs. Janssen Korea "Motilium-$M^{circledR}$" tablets) was assessed in healthy Korean volunteers after oral administration in a randomized crossover study. Blood samples were collected at spccified time intervals, and plasma concentration was measured as the amount of domperidone base using a validated HPLC method. The pharmacokinetic parameters of $AUC_{0{ ightarrow}48},; C_{max},;T_{max}$ and $t_{1/2}$ were determined from plasma concentration-time profile of two formulations. Any significant statistical differences were not observed between these two formulations. On the evaluation of bioequivalence according to Korea Food and Drug Administration Guideline, 90% confidence limits after logmithmic transformation fell within the acceptable range (log 0.8∼log 1.25). Based on these data, it can be concluded that two domperidone maleate tablets showed comparable pharmacokinetic profiles, which means that the Sinil "$Perinal^{circledR}$" tablet is bioequivalent to the Janssen Korea ""Motilium-M$^{circledR}$".