NCT02088697已完成1 期
A Bioequivalence Study of ASC-01 Placebo (Aripiprazole 0 mg/Sertraline 100 mg) and Sertraline Tablet in Healthy Male Subjects
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
- 50
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax) of Sertraline
研究概览
简要总结
The purpose of this study is to investigate the bioequivalence of ASC-01 Placebo and sertraline Tablet in Japanese healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers aged 20 to 40 years.
- •Have a body mass index (BMI) between 18.5 and 25.0 kg/m2 and a weight of at least 50 kg.
排除标准
- •History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study.
- •History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- •Any clinically significant abnormalities in the physical examination, clinical laboratory values, 12-lead ECG, or vital signs, as judged by the Investigator.
研究组 & 干预措施
ASC-01 placebo
Experimental
A single oral dose of ASC-01 Placebo (sertraline 100 mg)
干预措施: Placebo (Drug)
Sertraline tablet
Active Comparator
A single oral dose of sertraline tablets (sertraline 100 mg)
干预措施: ASC-01 (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax) of Sertraline
时间窗: predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144 and 168 hours postdose
次要结局
- Area Under the Plasma Concentration-time Curve From Time 0 to the Last Observable Concentration at Time t (AUCt) for Sertraline(predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144 and 168 hours postdose)
研究者
研究点 (1)
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