NCT01876316已完成不适用
A Randomized, Double-blind, Placebo-controlled, Two-way Crossover Trial to Compare Moxifloxacin Induced QT Interval Prolongation in Japanese and Korean Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- double delta QTcF
研究概览
简要总结
The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese Healthy Subjects
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Moxifloxacin
Active Comparator
single oral administration of 400mg of moxifloxacin
干预措施: Moxifloxacin (Drug)
Placebo
Placebo Comparator
single oral administration of 400mg of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
double delta QTcF
时间窗: up to 24 hours
12 point of ECG measurements according to the interventions
次要结局
- double delta QTcI, double delta QTcSS(up to 24 hours)
研究者
Jae-Gook Shin
Department of Pharmacology and Pharmacogenomics Research Center
Inje University
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