NCT01199328已完成1 期
A Phase I, Open, Two-way Crossover, Drug-drug Interaction Study Evaluating the Effect of Esomeprazole on the Pharmacodynamics of Acetylsalicylic Acid After 5 Days of Treatment
适应症
干预措施
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
- 34
- 试验地点
- 1
- 主要终点
- Evaluate the effect of esomeprazole on low-dose aspirin pharmacodynamics by assessing the relative change in the VerifyNow Aspirin test after 5 days of treatment, relative to baseline (Day 1) in healthy human volunteers
研究概览
简要总结
The purpose of this study is to assess the interaction between aspirin and Nexium in healthy volunteers.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision informed consent prior to any study specific procedures.
- •Healthy male and female subjects aged 18 to 75 years with suitable veins for cannulation or repeated vein puncture.
- •Healthy female subjects must be of non-childbearing potential (post-menopausal, had a hysterectomy and/or bilateral oophorectomy) or be of childbearing potential and have a negative serum hCG pregnancy test during screening and be using of the following methods of birth control:
- •Continuously practice abstinence during screening and throughout the duration of the study
- •Clinically accepted contraception as described under item 7 of Section 5.1 and on hormonal contraceptives.
- •Have a body mass index (BMI) between 19 and 30 kg/m2
- •No clinically significant abnormal findings as judged by the Investigator on enrollment physical exam.
排除标准
- •Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- •Previous enrolment or randomisation in the present study.
- •History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study e.g. history of any bleeding disorder, excessive bruising or ongoing or history of liver disease
- •History or presence of clinically significant gastrointestinal e.e. GI ulcer, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
- •Any clinically significant illness within 4 weeks of the first administration of investigational product.
研究组 & 干预措施
1
Active Comparator
Aspirin 81 mg
干预措施: Aspirin (Drug)
2
Active Comparator
Esomeprazole 20mg/aspirin 81mg
干预措施: Aspirin (Drug)
2
Active Comparator
Esomeprazole 20mg/aspirin 81mg
干预措施: Esomeprazole (Drug)
结局指标
主要结局
Evaluate the effect of esomeprazole on low-dose aspirin pharmacodynamics by assessing the relative change in the VerifyNow Aspirin test after 5 days of treatment, relative to baseline (Day 1) in healthy human volunteers
时间窗: Ongoing throughout the study from consent through withdrawal
次要结局
- Evaluate the effect of esomeprazole on low-dose aspirin pharmacodynamics by assessing the relative change in serum thromboxane B2 inhibition from baseline(Ongoing throughout the study from consent through withdrawal)
- Evaluate safety and tolerability of esomeprazole taken concurrently with low- dose aspirin(Ongoing throughout the study from consent through withdrawal)
研究者
研究点 (1)
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