A Randomized Clinical Trial to Validate Novel Biomarker Approaches After Single Doses of Anticoagulants in Healthy Young Male Subjects and in Healthy Elderly Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Level of fibrinopeptide A (FPA)
研究概览
简要总结
This is a study to investigate biomarkers after single oral doses of the anticoagulant agents dabigatran etexilate and rivaroxaban in healthy young male subjects and in healthy elderly subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dabigatran
Single 150-mg dose of dabigatran etexilate
干预措施: dabigatran etexilate (Drug)
Rivaroxaban
Single 20-mg dose of rivaroxaban
干预措施: rivaroxaban (Drug)
结局指标
主要结局
Level of fibrinopeptide A (FPA)
时间窗: From up to 2 hours pre-dose to up to 24 hours post-dose
Level of thrombin-antithrombin complex (TAT)
时间窗: From up to 2 hours pre-dose to up to 24 hours post-dose
Level of fibrin degradation product (D-dimer)
时间窗: From up to 2 hours pre-dose to up to 24 hours post-dose
Level of prothrombin split products (F1+2)
时间窗: From up to 2 hours pre-dose to up to 24 hours post-dose
Endogenous thrombin potential by Thrombin Generation Assay (TGA)-2a assay
时间窗: From up to 2 hours pre-dose to up to 24 hours post-dose
次要结局
未报告次要终点