New Oral Anticoagulant Drugs Dabigatran Etexilate and Rivaroxaban: Influence of Genetic Factors in Healthy Volunteers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- AUC of plasma concentrations of the drugs
研究概览
简要总结
The study will address the impact of genetical variation of a protein involved in the intestinal absorption of two new anticoagulants : Dabigatran etexilate and Rivaroxaban.
详细描述
The study will address the impact of genetical variation of a protein involved in the intestinal absorption of two new anticoagulants : Dabigatran etexilate and Rivaroxaban.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
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
- •Healthy participants
- •Aged between 18-35 years inclusive
- •Caucasian
- •Body mass index (BMI) between 18 and 27 kg per m² inclusive.
排除标准
- 未提供
研究组 & 干预措施
D->R->C+R
sequence of treatment: Dabigatran after rivaroxaban after chlarythromycin in association with rivaroxaban
干预措施: D->R->C+R (Drug)
D->R->C+D
sequence of treatment: Dabigatran after rivaroxaban after chlarythromycin in association with Dabigatran
干预措施: D->R->C+D (Drug)
R->D->C+D
sequence of treatment: rivaroxaban after Dabigatran after chlarythromycin in association with Dabigatran
干预措施: R->D->C+D (Drug)
R->D->C+R
sequence of treatment: rivaroxaban after Dabigatran after chlarythromycin in association with rivaroxaban
干预措施: R->D->C+R (Drug)
结局指标
主要结局
AUC of plasma concentrations of the drugs
时间窗: over 24h after single oral dose
次要结局
- PKD of the drugs(over 24h after single oral dose)