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
- Conditions
- Healthy male
- Registration Number
- JPRN-UMIN000005924
- Lead Sponsor
- Medical Co. LTA Clinical Pharmacology Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 64
Not provided
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 Subjects who donated and/or withdrawn whole blood more than 400mL within 12 weeks, 200mL within 4 weeks, and/or blood component within 2 weeks prior to administration of period 1. 9, Subjects who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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method QT/QTc interval and pharmacokinetics after single dose of Moxifloxacin
- Secondary Outcome Measures
Name Time Method