A Randomized, Actively Controlled, Crossover Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Patients With Type II Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time to 99% Inhibition of Serum Thromboxane (TxB2)
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 plain aspirin and enteric coated aspirin, and to test whether PL2200 is able to prevent blood clots as effectively as these other products, 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
- •Adults 21-79
- •Body mass index (BMI) of 30-40 kg/m2
- •Non-insulin-dependent type-2 diabetics (as confirmed by hemoglobin A1c (HbA1c) of > 6.4% and/or fasting plasma glucose of >125 mg/dL or current anti-diabetic medication)
- •AA-induced platelet aggregation response of >60% within 3 hours prior to initial dose of study drug administration
排除标准
- •Contraindications to aspirin
- •Previous history of vascular disease
- •Patient requires insulin
- •Use of non-steroidal anti-inflammatory drugs, anti-secretory agents, antacids, and salicylate-containing nutritional supplements within 2 weeks of randomization
研究组 & 干预措施
Enteric-coated aspirin caplets
Active comparator; crossover design
干预措施: Enteric-coated aspirin caplets (Drug)
PL2200 Aspirin Capsules
Investigational drug arm; crossover design
干预措施: PL2200 Aspirin Capsules (Drug)
Immediate-Release Aspirin Tablets
Active comparator; crossover design
干预措施: Immediate-Release Aspirin Tablets (Drug)
结局指标
主要结局
Time to 99% Inhibition of Serum Thromboxane (TxB2)
时间窗: 4 days
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