NCT02122939已完成1 期
An Open-label, Single Dosing Clinical Trial to Investigate the Pharmacokinetics and the Effect on ECG of Escitalopram After Oral Administration in Elderly Volunteers
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
- 12
- 试验地点
- 1
- 主要终点
- Cmax, AUCinf, AUClast, Tmax, t1/2, CL/F
研究概览
简要总结
An Open-label, single dosing clinical trial to investigate the pharmacokinetics and the effect on ECG of escitalopram after oral administration in elderly volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy subject aged 65 or older at screening
- •A body weight in the range of 50 kg (inclusive) to 90 kg (inclusive) with BMI range of 19.0 to 28.0
- •subjects who decide to participate voluntarily and write a informed consent form
排除标准
- •subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
- •Subject judged not eligible for study participation by investigator
研究组 & 干预措施
Escitalopram
Experimental
干预措施: Escitalopram (Drug)
结局指标
主要结局
Cmax, AUCinf, AUClast, Tmax, t1/2, CL/F
时间窗: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 32, 48 h post-dose
次要结局
- QTc interval(pre-dose, 1, 4, 6, 8, 12, 24, 28, 32, 48 h post-dose)
研究者
Jae Yong Chung
Associate professor
Seoul National University Bundang Hospital
研究点 (1)
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