An Open-label, Randomized, 4-treatment, 3-period, Crossover Interaction Study, Evaluating the Effect of Esomeprazole 40 mg, Omeprazole 80 mg or Lansoprazole 60 mg on the Pharmacodynamics and the Pharmacokinetics of Clopidogrel in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Assess the effect of esomeprazole 40 mg, omeprazole 80 mg or lansoprazole 60 mg on the PK profile of clopidogrel active metabolite by assessing the inhibition of platelet aggregation (mIPA).
研究概览
简要总结
The aim of this study is to determine if there is a pharmacological interaction between clopidogrel and different types of proton pump inhibitors (PPIs), and if the extent of this possible interaction would change over time.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males within the age of 18-45 years and females within the age of 18-55 years with suitable veins for cannulation or repeated vein puncture. Females must be of non-childbearing potential.
- •Weight of 50-95kg, inclusive, and a BMI between 19-30 kg/m2, inclusive.
- •No clinically significant abnormal findings as judged by the Investigator on enrollment physical exam.
排除标准
- •History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in study.
- •History or presence of gastrointestinal e.g. 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. Any medical/surgical procedure or trauma within 3 months of the treatment period; scheduled surgery, including dental surgery within 2 weeks.
研究组 & 干预措施
1
lansoprazole 60 mg + clopidogrel 300 mg/ 75 mg
干预措施: clopidogrel (Drug)
1
lansoprazole 60 mg + clopidogrel 300 mg/ 75 mg
干预措施: lansoprazole (Drug)
2
omeprazole 80 mg + clopidogrel 300/75 mg
干预措施: omeprazole (Drug)
2
omeprazole 80 mg + clopidogrel 300/75 mg
干预措施: clopidogrel (Drug)
3
esomeprazole 40 mg + clopidogrel 300/75 mg
干预措施: esomeprazole (Drug)
3
esomeprazole 40 mg + clopidogrel 300/75 mg
干预措施: clopidogrel (Drug)
4
clopidogrel 300/75 mg alone
干预措施: clopidogrel (Drug)
结局指标
主要结局
Assess the effect of esomeprazole 40 mg, omeprazole 80 mg or lansoprazole 60 mg on the PK profile of clopidogrel active metabolite by assessing the inhibition of platelet aggregation (mIPA).
时间窗: Day 30
次要结局
- Assess the effect of esomeprazole 40 mg, omeprazole 80 mg or lansoprazole 60 mg on the PK profile of clopidogrel active metabolite by assessing the AUC, AUC 0-t and Cmax after the loading dose of clopidogrel (Day 1) and AUC 0-t, ss and Css, max.(Days 5,14, 29)
- Evaluate the safety and tolerability of clopidogrel given concomittantly with esomeprazole, omeprazole or lansoprazole by assessment of adverse events and calculation of change from baseline for clinical laboratory tests, vital signs and pECG.(Every in-house day)