Reliable Inhibition of Thrombocyte Activity: Comparison of PL2200 Aspirin Capsules, 325 mg and Enteric-Coated Aspirin (RITE Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 3
- 主要终点
- Time to 99% Inhibition of Serum Thromboxane
研究概览
简要总结
This study will determine if aspirin from PL2200, an investigational product, gets into the blood stream as quickly as enteric coated aspirin, and to test whether PL2200 is able to prevent blood clots as effectively as enteric coated aspirin, when administered to patients with diabetes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-Insulin-Dependent Diabetes Mellitus
- •Adults 21 to 79 years, inclusive
- •Body mass index between 30 and 40 kg/m2, inclusive
排除标准
- •Currently prescribed aspirin or anti-coagulants
- •Contraindications to aspirin
- •Significant disease history or active disease other than Non-Insulin-Dependent Diabetes Mellitus
- •Patient requires insulin
研究组 & 干预措施
PL2200 Aspirin Capsules
PL2200 Aspirin Capsules
干预措施: PL2200 Aspirin Capsules (Drug)
Enteric-coated aspirin caplets
Enteric-coated aspirin caplets
干预措施: Enteric-coated aspirin caplets (Drug)
结局指标
主要结局
Time to 99% Inhibition of Serum Thromboxane
时间窗: 11 days
Serial measurements of aspirin anti-platelet activity will be collected over 11 days, and compared between groups, to allow a determination of pharmacodynamic (anti-platelet) bioequivalence between study drugs. Aspirin's antiplatelet activity is measured by the capacity of platelets to generate serum thromboxane (a surrogate marker for inhibition of COX-1 by aspirin). Inhibition of serum thromboxane is a key marker of antiplatelet efficacy.
次要结局
未报告次要终点