NCT02262533已完成1 期
Drug Interaction Study of Apixaban and Atenolol in Healthy Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2007年6月最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Apixaban and Atenolol plasma concentration
研究概览
简要总结
The purpose of this study is to assess the effect of Atenolol 100 mg on the Pharmacokinetics (PK) of Apixaban and the effect of Apixaban 10 mg on the PK of Atenolol in Healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECGs), and clinical laboratory determinations
排除标准
- •Any significant acute or chronic medical illness, history of hypotension, history or evidence of abnormal bleeding or coagulation disorders, significant head injury within the last 2 years
研究组 & 干预措施
Treatment A: Apixaban
Experimental
Apixaban tablet by mouth on specified day
干预措施: Apixaban (Drug)
Treatment B: Atenolol
Experimental
Atenolol tablet by mouth on specified day
干预措施: Atenolol (Drug)
Treatment C: Apixaban and Atenolol
Experimental
Apixaban and Atenolol tablets by mouth on specified day
干预措施: Apixaban (Drug)
Treatment C: Apixaban and Atenolol
Experimental
Apixaban and Atenolol tablets by mouth on specified day
干预措施: Atenolol (Drug)
结局指标
主要结局
Apixaban and Atenolol plasma concentration
时间窗: Days 1-13
Blood samples for Atenolol PK were collected on days 1-3 of each period (Treatment B and C). Blood samples for Apixaban PK were collected on days 1-4 of each period (Treatment A and C)
次要结局
- Safety and Tolerability based on adverse events (AE) reports and the results of vital sign measurements, electrocardiogram (ECGs), physical examinations, and clinical laboratory tests(Days 1-13)
研究者
研究点 (1)
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