NCT04811625已完成4 期
A Randomized, Open-label, 2-way Crossover Pharmacodynamic and Pharmacokinetic Study of a Novel Pharmaceutical Lipid-aspirin Complex Formulation (PL-ASA) at an 81 mg Dose
PLx Pharma1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年4月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Acetylsalicylic acid and salicylic acid
研究概览
简要总结
A randomized, open-label, 2-way crossover pharmacodynamic and pharmacokinetic study of a novel pharmaceutical lipid-aspirin complex formulation (PL-ASA) at an 81 mg dose
详细描述
This study is a randomized, open-label, 2-way crossover study to assess pharmacodyamic and pharmacokinetic profiles following treatment with PL-ASA and EC-ASA administered under fasting condition at a single dose of 81 mg among the volunteers aged 50 to 75 years.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female non-smoking subjects between the ages of 18 to 75 years inclusive, without known medical conditions requiring treatment
- •Consumes on average no more than 2 alcoholic drinks per day for 30 days prior to study
排除标准
- •Abnormal baseline laboratory results
- •Current prescribed use of aspirin, warfarin or other anticoagulants
- •Use of other specific medications within 2 weeks of study start
- •History of certain medical conditions
- •Subject's platelets are unresponsive to arachidonic acid, as defined as <60% of aggregation as measured by light transmittance aggregometry
研究组 & 干预措施
PL-ASA capsule, then EC-ASA tablet
Other
PL-ASA capsule 81 mg, then crossover to EC-ASA tablet 81 mg
干预措施: PL-ASA (Drug)
EC-ASA tablet, then PL-ASA capsule
Active Comparator
EC-ASA tablet 81 mg, then crossover to PL-ASA capsule 81 mg
干预措施: PL-ASA (Drug)
结局指标
主要结局
Acetylsalicylic acid and salicylic acid
时间窗: 24 hours after dosing
Presence of serum acetylsalicylic acid and salicylic acid
次要结局
- Light transmittance aggregometry(24 hours after dosing)
研究者
研究点 (1)
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