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KMID : 0941820080180020106
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Korean Journal of Clinical Pharmacy
2008 Volume.18 No. 2 p.106 ~ p.113
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Bioequivalence Assessment of DM Tablet to Motilium-M® Tablet
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Cho Seong-Wan
Kim Young-Il
Lee Jong-Oh
Bang Joon-Seok
Jeong Ji-Hoon
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Abstract
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The aim of this study was to evaluate the bioequivalence of two domperidone preparations. Bioequivalence assessmentwas conducted on 34 healthy volunteers who received two tablets (Domperidone Maleate, 12.72mg/tablet) in the fast-ing state, in a randomized balanced 2×2 cross-over study design. This whole study was performed according to theimplementation guidelines of the Korea Food Drug Administration. After dosing of two tablets, blood samples werecollected serially for a period of 36 hours. Plasma was analyzed for domperidone by using LC/MS/MS assay method.The analysis system was validated in specificity, accuracy, precision, and linearity. AUCt, (the area under the plasmaconcentration-time curve from the zero-time to 36 hr) was calculated through the trapezoidal rule. Cmax (maximumplasma drug concentration) and Tmax (time to reach Cmax) were compiled from the plasma domperidone concentration-time data of each volunteer. No significant sequence effect was found for the bioavailability parameters indicating thatthe cross-over design was properly performed. The 90%-Confidence intervals of the AUCt ratio and the Cmax were fromlog 0.8007 to log 1.1240 and log 0.8645- log 1.2483, respectively. These values were within the acceptable bioequiva-lence intervals between 0.80 and 1.25. Therefore, this study demonstrated that two formulations have bioequivalencewith respect to the rate and extent of absorption.
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KEYWORD
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Domperidone, Bioequivalence, LC/MS/MS, Motilium-M®
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