The effects of a single oral therapeutic dose of Moxifloxacin on the QT/QTc interval and pharmacokinetics of healthy Japanese male volunteers. - multicenter, digital 12-lead Holter ECG trial- - The effects of a single oral therapeutic dose of Moxifloxacin on the QT/QTc interval and pharmacokinetics of healthy Japanese male volunteers. - multicenter, digital 12-lead Holter ECG trial

Medical Co. LTA Clinical Pharmacology Center0 个研究点目标入组 64 人开始时间: 2011年7月5日最近更新: 2023年10月17日

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•1, Subjects with present illness which requires treatment. 2, Subjects with past medical history which was considered not adequate for this study. 3, Subjects with past history of drug allergy (includes allergy to Moxifloxacin). 4, Subjects with abnormal finding on 12-lead ECG which might interfere with the completion of this study at screening, admission of site at period 1, and pre-dose. 5, Subjects with family history of LQT syndrome. 6, Subjects who took medication/supplement which is known to affect QT/QTc interval 3 months prior to administration of period 1. 7, Subjects who took prescribed medicine and/or OTC drug 1 week prior to administration of period 1. 8. Subjects who donated and/or withdrawn whole blood more than 400mL within 12 weeks, 200mL within 4 weeks, and/or blood component within 2 weeks prior to administration of period 1. 9, Subjects who participated in a clinical trial and was administered study drug. 10, Subjects with history of alcohol and/or drug abuse. 11, Subjects who was judged not appropriate for this study by study physician.

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Medical Co. LTA Clinical Pharmacology Center