NCT01443208已完成1 期
A Phase 1, Randomized, Subject- and Investigator-Blind, Placebo-Controlled, Parallel-Group, Single and Multiple-Dose Study of Desvenlafaxine in Korean Healthy 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
- 发起方
- Pfizer
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- For multiple dose: trough concentration (Ctrough)
研究概览
简要总结
To evaluate the pharmacokinetics and safety of single dose and multiple doses of desvenlafaxine in Korean healthy subjects and compare to westerners.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and/or female subjects
- •Between the ages of 18 and 55 years, inclusive
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)
排除标准
- •Elevated risk of suicide, in the opinion of the investigator or expert consultant
- •Pregnant or nursing females
- •Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception
研究组 & 干预措施
100 mg
Experimental
干预措施: desvenlafaxine (Drug)
50 mg
Experimental
干预措施: desvenlafaxine (Drug)
200 mg
Experimental
干预措施: desvenlafaxine (Drug)
结局指标
主要结局
For multiple dose: trough concentration (Ctrough)
时间窗: day 8
For single dose: time to first occurence of Cmax (Tmax)
时间窗: day 1
For single dose: area under curve (0-time for last quantifiable concentration) (AUClast)
时间窗: day 1
For multiple dose: area under curve (0-24hours) (AUC0-24)
时间窗: day 8
For multiple dose: maximum concentration (Cmax)
时间窗: day 8
For single dose: maximum concentration (Cmax)
时间窗: day 1
For multiple dose: time to first occurence of Cmax (Tmax)
时间窗: day 8
次要结局
- For multiple dose if data permit: accumulation factor (Rac)(day 8)
- For multiple dose if data permit: terminal elimination half life (t1/2)(day 8)
- For multiple dose if data permit: apparent volume of distribution (Vz/F)(day 8)
- For single dose if data permit: terminal elimination half life (t1/2)(day 1)
- For single dose if data permit: apparent volume of distribution (Vz/F)(day 1)
- For single dose if data permit: oral clearance (CL/F)(day 1)
- For multiple dose if data permit: oral clearance (CL/F)(day 8)
- For single dose if data permit: area under curve (0-infinity) (AUCinf)(day 1)
研究者
研究点 (1)
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