The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese Healthy Subjects

Study Overview
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Brief Summary
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The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese Healthy Subjects

Detailed Description
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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.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Two-way Crossover Trial to Compare Moxifloxacin Induced QT Interval Prolongation in Japanese and Korean Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Moxifloxacin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 1) 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. 2) Body Mass Index (BMI) of 17.6 to 26.4 kg/m2, BMI = weight (kg)/ [height (m)]2. Exclusion Criteria: 1) 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. 2) 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Moxifloxacin<br>single oral administration of 400mg of moxifloxacin | Drug: Moxifloxacin<br>* single oral administration of 400mg of moxifloxacin<br>* Other names: Avelox;|
| Placebo Comparator: Placebo<br>single oral administration of 400mg of placebo | Drug: Placebo<br>* single oral administration of 400mg of placebo<br>* Other names: Lactose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| double delta QTcF | 12 point of ECG measurements according to the interventions | up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| double delta QTcI, double delta QTcSS |  | up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moxifloxacin, QT interval prolongation, Korean, Japanese