The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese Healthy Subjects
- Registration Number
- NCT01876316
- Lead Sponsor
- Inje University
- Brief Summary
The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese Healthy Subjects
- Detailed Description
The purpose of this study is to explore the ethnic and gender difference in the Moxifloxacin induced QT interval prolongation between Japanese and Korean subjects.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
-
- Subjects in Japan and Korea deemed healthy as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, or clinical laboratory determinations.
- Body Mass Index (BMI) of 17.6 to 26.4 kg/m2, BMI = weight (kg)/ [height (m)]2.
Exclusion Criteria
-
-
Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.
-
Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat.
-
- Heart rate ≤ 45 bpmmsec or Heart rate ≥ 100 bpmmsec
- PR ≥ 210 msec
- QRS ≥ 120 msec
- QT ≥ 500 msec
- QTcF: male ≥ 450 msec, female ≥470msec
- Iincomplete right bundle branch block
- Marked Sinus Arrhythmia
- Wondering pacemaker
- Atrial rhythm
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo single oral administration of 400mg of placebo Moxifloxacin Moxifloxacin single oral administration of 400mg of moxifloxacin
- Primary Outcome Measures
Name Time Method double delta QTcF up to 24 hours 12 point of ECG measurements according to the interventions
- Secondary Outcome Measures
Name Time Method double delta QTcI, double delta QTcSS up to 24 hours