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KMID : 0869620030200040001
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Journal of Korean Society of Hospital Pharmacists
2003 Volume.20 No. 4 p.1 ~ p.15
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Bioequivalence Assessment of Shinpoong Dompil^(®) Tablet Containing 12.72 mg of Domperidone Maleate
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유안나/Yoo, Anna
김성철/이경희/박종민/남두현/Kim, Sung Chull/Lee, Kyung Hee/Park, Jong Min/Nam, Doo Hyun
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Abstract
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The bioequivalence of two tablet formulations of 12.72㎎ domperidone maleate (Shinpoong "Dompil^(®)" table vs. Janssen Korea "Motilium-M^(®)" tablets) was assessed in healthy Korea volunteers after oral administration in a randomized crossover study. Blood samples were collected at specified time intervals, and plasma concentration was measured as the amount of domperidone base using a validated HPLC method. The pharmacokinetic parameters of AUC_(0→48), C_(max), T_(max) and t_(1/2) were determined from plasma concentration-time profile of two formulations. No significant statistical differences were observed between these two formulations. On the evaluation of bioequivalence according to KFDA Guideline, 90% confidence limits after logarithmic 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 Shinpoong "Dompil^(®)" tablet is bioequivalent to the Janssen Korea "Motilium-M^(®)"
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