NCT01094483已完成1 期
A Phase I Prospective, Randomized, Double-blind, Placebo-controlled Study Assessing Inhibition of Serum Thromboxane B2 Levels With PN 400 and Low Dose Aspirin
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
- 40
- 试验地点
- 1
- 主要终点
- Pharmacodynamic: Mean percent inhibition of serum thromboxane B2
研究概览
简要总结
The primary hypothesis of this study is that concomitant multiple-dose administration of PN 400 does not interfere with the platelet inhibitory effects of enteric-coated low-dose aspirin (81 mg), as measured by serum thromboxane B2 inhibition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stable without clinically significant disease
排除标准
- •Use of NSAID within 2 weeks
- •Type 1 or 2 DM
- •GI disorder
研究组 & 干预措施
1
Experimental
PN400 + ASA
干预措施: PN400 (Drug)
1
Experimental
PN400 + ASA
干预措施: ASA (Drug)
2
Placebo Comparator
Placebo + ASA
干预措施: ASA (Drug)
2
Placebo Comparator
Placebo + ASA
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacodynamic: Mean percent inhibition of serum thromboxane B2
时间窗: measured on the morning of Day 6 (Period 1), and 24 hours after the Day 10 morning dose of aspirin (ie, Day 11) in Period 2
Safety: Parameters include: physical examination, vital signs, clinical laboratory tests, adverse events
时间窗: during approx 6 week study period
次要结局
未报告次要终点
研究者
研究点 (1)
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