Healthy male
Conditions
Interventions
To administer single oral dose of Moxifloxacin 400mg
To administer single oral dose of placebo
Sponsors
Medical Co. LTA Clinical Pharmacology Center
Ina Research Inc. Cardiocore Lab, Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1, Healthy Japanese male subjects who provide signed written informed consent. 2, Subjects between 20 and 40 (inclusive) year of age at the time of consent. 3, Subjects with BMI <=18.5 and >25.0 at the time of screening. 4, Subjects judged as adequate for this study by study physician.
Exclusion criteria
Exclusion criteria: 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 Subjects who donated and/or withdrawn whole blood more than 400mL within 12 weeks, 200mL within 4 weeks, and/or blood component within 2 weeks prior to administration of period 1. 9, Subjects who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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| QT/QTc interval and pharmacokinetics after single dose of Moxifloxacin | — |
Countries
Japan
Outcome results
None listed