NCT01014247已完成1 期
A Randomized, Double-blind, 2-way Crossover, Placebo-controlled Study to Investigate the Influence of a Single-dose of Moxifloxacin on the QTc Interval in Healthy Male and Female Subjects for Positive Control Validation in Selected Centers of the PATENT-1 Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 56
- 主要终点
- QTc interval at 3 hours
研究概览
简要总结
The aim of this study is to investigate the effect of moxifloxacin on the QT interval in order to gain information on the validity of results that will be collected during another clinical study testing riociguat in patients with pulmonary arterial hypertension (PATENT-1 study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Age 18-75 years - Normal ECG
排除标准
- •Abnormal ECG - Intolerance to fluorochinolones
研究组 & 干预措施
Arm 1
Active Comparator
干预措施: Avelox (Moxifloxacin, BAY12-8039) (Drug)
Arm 2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
QTc interval at 3 hours
时间窗: Day 1 of treatment period 1 and 2
次要结局
- Safety variables(Up to last visit of follow up)
- Pharmacokinetic parameters(On different time points)
研究者
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