NCT00689559已完成1 期
A Single-Centre, Double-Blind, Randomised, Parallel Group Study of Repeated Oral Doses of AZD3480/Placebo and a Single Dose of Aripiprazole to Evaluate the Pharmacokinetic Interaction Between AZD3480 and Aripiprazole in Healthy Subjects (Phase I)
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
- AstraZeneca
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- PK variables
研究概览
简要总结
The purpose of the study is to evaluate if AZD3480 and warfarin interact with each other or not, i.e. show the same or altered plasma concentration profiles when co-administered compared to administered alone.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of signed written informed consent
- •Clinically normal physical findings and laboratory values
排除标准
- •Clinically significant illness or clinically relevant trauma within three weeks before the first dose
- •History of clinically significant disease
- •Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product
研究组 & 干预措施
1
Experimental
AZD3480 + Aripiprazole
干预措施: AZD3480 (Drug)
1
Experimental
AZD3480 + Aripiprazole
干预措施: Aripiprazole (Drug)
2
Experimental
Placebo + Aripiprazole
干预措施: Placebo (Drug)
2
Experimental
Placebo + Aripiprazole
干预措施: Aripiprazole (Drug)
结局指标
主要结局
PK variables
时间窗: Frequent sampling occasions during
次要结局
- Safety variables (adverse events, blood pressure, pulse, safety lab)(During the whole treatment period)
研究者
研究点 (1)
Loading locations...
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