NCT02361619已完成1 期
An Open-label Crossover Trial Assessing the Value of Dabigatran in a Drug Interaction Cocktail in Healthy Young 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
- 16
- 试验地点
- 1
- 主要终点
- AUC of dabigatran in plasma
研究概览
简要总结
Four periods of oral dosing following overnight fasting (1. known metabolic probe drug cocktail consisting of caffeine, diclofenac, esomeprazole, metoprolol, midazolam; 2. dabigatran + cocktail; 3. dabigatran alone; 4. clarithromycin 3 days + cocktail + dabigatran). Blood samples collected for pharmacokinetics over 24 h. Washout between periods. Adverse events, haematology and clinical chemistry recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- Female
- 接受健康志愿者
- 是
入选标准
- •Weight at least 50 kg and body mass index 19 - 30 kg m-2
- •Normal clinical laboratory profiles
- •No childbearing potential or use of adequate contraceptive measures
排除标准
- •Blood loss >300 ml within 2 months prior to the first dosing day
- •Pregnancy, breastfeeding
- •Allergy or hypersensitivity to caffeine, diclofenac, esomeprazole, metoprolol, midazolam, dabigatran or clarithromycin or to excipients in the pharmaceutical products
- •Infection with HIV, HBV or HCV
- •Participation in the preceding 3 months or concomitantly in any clinical drug study
- •Suspected current drug or alcohol abuse
- •History of drug or alcohol abuse.
- •Concomitant medication with the exception of hormonal contraception.
- •Positive result in urine test for drug abuse.
- •Nicotine consumption equivalent to >5 cigarettes per day
研究组 & 干预措施
1
Experimental
干预措施: Caffeine (Drug)
1
Experimental
干预措施: Diclofenac (Drug)
1
Experimental
干预措施: Esomeprazole (Drug)
1
Experimental
干预措施: Metoprolol (Drug)
1
Experimental
干预措施: Midazolam (Drug)
1
Experimental
干预措施: Dabigatran (Drug)
1
Experimental
干预措施: Clarithromycin (Drug)
结局指标
主要结局
AUC of dabigatran in plasma
时间窗: 24 h
Exposure ratio for dabigatran in combination and dabigatran alone
次要结局
- Number of subjects with adverse events(23 days)
研究者
研究点 (1)
Loading locations...
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