Drug-drug Interaction Study of the Effect of Omeprazole 80 mg q.d. at Steady State on the Pharmacokinetics and Pharmacodynamics of Aggrenox® Every 12 Hours at Steady State in Healthy Male and Female Volunteers (an Open-label, Randomised, Crossover Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Plasma Dipyridamole Maximum Concentration (Cmax)
研究概览
简要总结
The objective of the current study is to investigate if a drug-drug interaction occurs with the administration of omeprazole 80 mg q.d. at steady state on the pharmacokinetics of dipyridamole and the pharmacodynamics of ASA-induced platelet aggregation inhibition (components of Aggrenox®) when administered every 12 hours at steady state.
详细描述
Purpose:
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 50 Years（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
Treatment A
Aggrenox alone
干预措施: Aggrenox alone (Drug)
Treatment B
Aggrenox and omeprazole
干预措施: Aggrenox and omeprazole (Drug)
Treatment C
Omeprazole alone
干预措施: Omeprazole alone (Drug)
Treatment D
Aggrenox and omeprazole
干预措施: Aggrenox and omeprazole (Drug)
结局指标
主要结局
Plasma Dipyridamole Maximum Concentration (Cmax)
时间窗: 7 days
Maximum measured concentration of dipyridamole in plasma
Plasma Dipyridamole Area Under Plasma Concentration-time Curve From Zero to 12 Hours (AUC0-12)
时间窗: 7 days
Area under the concentration time curve of the analyte in plasma from 0 to 12 hours at steady state
Inhibition of Platelet Aggregation at 4 Hours Post Dose (IPA4)
时间窗: 7 days
IPA4 equals the platelet aggregation measured 4 hours post dose divided by the platelet aggregation measured at baseline (multiplied by 100).
次要结局
- Percentage Peak-to-trough Fluctuation (%PTF)(7 days)
- Plasma Dipyridamole Minimum Concentration (Cmin)(7 days)
- Inhibition of Platelet Aggregation at 12 Hours Post Dose (IPA12)(7 days)