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KMID : 0606920030110020145
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Biomolecules & Therapeutics
2003 Volume.11 No. 2 p.145 ~ p.150
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Bioequivalence Assessment of Domperidone Maleate Tablets in Healthy Korean Volunteers
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Kim SC
Lee JW/Yoo AN/Chang HS/Lee KH/Park JM/Nam DH
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Abstract
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The bioequivalence of two tablet formulations of 12.72㎎ domperidone maleate (Sinil ″Perinal/sup (R)/″ tablets vs. Janssen Korea ″Motilium-M/sup (R)/″ 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/sub 0→48/, C/sub max/ T/sub max/ and t/sub 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/sup (R)/″ tablet is bioequivalent to the Janssen Korea ″Motilium-M/sup (R)/″.
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