NCT01871701已完成1 期
Clinical Trial to Investigate the Effect on Corrected QT Interval Prolongation by Psychotropic Drugs in Healthy Korean Adults After a Single Oral Administration of Escitalopram, Quetiapine, and Moxifloxacin
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Corrected QT interval prolongation
研究概览
简要总结
To evaluate the corrected QT interval change(automatic-reading) after single oral administration of escitalopram, quetiapine and moxifloxacin versus placebo in healthy Korean Adults.
详细描述
Randomized, Open-label, Placebo-controlled, 4-way crossover 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
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects aged 20 - 40 years.
- •A body weight in the range of 50 kg (inclusive) - 90 kg (inclusive) and a body mass index (BMI) in the range 19.0 kg/m2 (inclusive) - 25.0 kg/m2 (inclusive).
- •Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully. informed about the study procedures.
排除标准
- •Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (Escitalopram, Quetiapine, Moxifloxacin)) or other quinolone group antibiotics.
- •Subject judged not eligible for study participation by investigator.
研究组 & 干预措施
Quetiapine
Experimental
Quetiapine 100 mg (Seroquel, Tablet)
干预措施: Quetiapine (Drug)
Moxifloxacin
Experimental
Moxifloxacin 400 mg (Avelox, Tablet)
干预措施: Moxifloxacin (Drug)
Escitalopram
Experimental
Escitalopram 20 mg (Lexapro, Tablet)
干预措施: Escitalopram (Drug)
Placebo
Placebo Comparator
Water intake
干预措施: Placebo (Other)
结局指标
主要结局
Corrected QT interval prolongation
时间窗: Predose (3 times) and 1, 2, 3, 4, 6, 8, 12, 16, 24 h, additional 26, 28, 32, 48 h after escitalopram dosing
次要结局
- AUC (area under the plasma concentration-time curve) of escitalopram(Predose and 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48h postdose)
- AUC (area under the plasma concentration-time curve)of quetiapine, moxifloxacin(Predose and 1, 2, 3, 4, 6, 8, 12, 16, 24 h postdose)
研究者
Jae Yong Chung
Assistant Professor
Seoul National University Bundang Hospital
研究点 (1)
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