NCT01350921已完成1 期
A Sequential, Open Label Study to Compare the Pharmacokinetics, Safety and Tolerability of Ticagrelor and Venlafaxine Given Concomitantly in Healthy Subjects Aged 18 to 45 Years
适应症
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
- 22
- 试验地点
- 2
- 主要终点
- area under the plasma concentration-time curve during a dosing interval (AUCτ) and observed maximum plasma concentration (Cmax)
研究概览
简要总结
Study evaluates the drug-drug interaction between Ticagrelor and Venlafaxine when taken together in healthy volunteers
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •a weight of at least 50 kg and a body mass index between 18 to 30 kg/m2
排除标准
- •History of clinically significant disease or disorder as judged by the investigator
- •Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of drug.
- •History of haemophilia, von Willebrand´s disease, lupus anticoagulant or other diseases/syndromes that may alter or increase bleeding.
- •History of previous or ongoing psychiatric disease
结局指标
主要结局
area under the plasma concentration-time curve during a dosing interval (AUCτ) and observed maximum plasma concentration (Cmax)
时间窗: Multiple assessments during day 8 and 9.
Venlafaxine and O-desmethylvenlafaxine (ODV) on Day 8 (after multiple dose administration of venlafaxine for 4 days) and Day 9 (after concomitant administration of venlafaxine and ticagrelor):
次要结局
- Venlafaxine and ODV on Days 8 and 9: time to Cmax (tmax)(Multiple assessments during day 1 and 9-11)
- Safety and tolerability of ticagrelor and venlafaxine when given concomitantly by assessments of amount of adverse events(Multiple assessments from day -1 do day 12 and a single assessment at follow up visit.)
研究者
研究点 (2)
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