Pharmacokinetic and Pharmacodynamic Assessment of a Novel, Pharmaceutical Lipid-Aspirin Complex
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 主要终点
- Bioequivalence of PL-ASA and Immediate Release Aspirin AUC0-T
研究概览
简要总结
Prospective, Randomized, Crossover, Bioequivalence study
详细描述
Active-control crossover study randomizing 32 healthy volunteers to receive one of two dose levels, 325 mg or 650 mg, of either PL-ASA or immediate release aspirin within a two week washout period between treatments. The primary objectives are to assess PK and PD bioequivalence and safety over a twenty four hour period for PL-ASA and immediate release aspirin at 325 mg and 650 mg dose strengths.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •If female and of childbearing potential, subject has a negative pregnancy test and is not nursing.
- •If female and of childbearing potential, subject is using adequate birth control for the duration of the study.
- •Subject is able to understand and comply with study procedures.
- •Subject is a non-smoker.
- •Subject consumes no more than 1 alcoholic drink per day.
- •Subject agrees to refrain from alcohol consumption for 48 hours prior to each drug administration and 48 hours after each drug administration.
- •Subject is able and willing to provide written informed consent prior to any study procedures being performed.
排除标准
- •Subject has abnormal screening/baseline laboratory parameters deemed to be clinically significant by the Investigator.
- •Subject has taken any prescription medications other than hormone replacement therapy or thyroid replacement hormones within 3 days prior to drug administration.
- •Subject has taken any of the following medications within 2 weeks prior to study entry:
- •NSAIDs or other medications for pain, including aspirin or aspirin containing products and acetaminophen (see Appendix B of protocol in Appendix 16.1.1)
- •Proton pump inhibitors, including Prilosec®, Prevacid®, Aciphex®, Protonix®, or Nexium®
- •H-2 blockers, including Tagamet®, Zantac®, Axid®, or Pepcid®
- •Any antiplatelet agent, including Plavix®, Ticlid®, Pletal®, ReoPro®, Integrilin®, Aggrastat®, or Persantine®
- •Any anti-coagulant, including Coumadin®, Acenocoumarol, Phenprocoumon, Phenindione, Heparin, Exanta®, Argatroban, Lepirudin, Hirudin or Bivalirudin
- •Subject has used an investigational agent within the past 30 days.
- •Subject has hypersensitivity or contraindications to aspirin, ibuprofen, or other NSAID.
- •Subject has sensitivity to lecithin.
- •Subject has a history of gastrointestinal problems including ulcers, frequent indigestion, or heartburn.
- •Subject has a history of stroke, myocardial infarction, or congestive heart failure.
- •Subject has a history of asthma, other bronchospastic activity, nasal polyps, or angioedema other than resolved childhood asthma.
- •Subject has a history of kidney or liver disease.
- •Subject has a history of thrombocytopenia, neutropenia, or bleeding disorder.
- •Subject has a history of coronary arterial bypass.
- •Subject has a history of non-trauma related hemorrhage.
- •Subject has a history of chronic hypertension.
- •Subject is currently enrolled in another investigational trial.
- •Subject's platelets are unresponsive to arachidonic acid
研究组 & 干预措施
PL-ASA 325 mg
Novel aspirin formulation being tested
干预措施: Aspirin (Drug)
IR 325 mg
Immediate release aspirin
干预措施: Aspirin (Drug)
PL-ASA-650
Novel aspirin formulation being tested
干预措施: Aspirin (Drug)
IR 650
Immediate release aspirin
干预措施: Aspirin (Drug)
结局指标
主要结局
Bioequivalence of PL-ASA and Immediate Release Aspirin AUC0-T
时间窗: twenty four hours
Assess for bioequivalence at 325 mg and 650 mg dose levels AUC0-T of the metabolite salicylic acid
Bioequivalence of PL-ASA and Immediate Release Aspirin AUC0-∞
时间窗: 24 hours
Assess for bioequivalence at 325 mg and 650 mg dose levels AUC0-∞ of the metabolite salicylic acid
Bioequivalence of PL-ASA and Immediate Release Aspirin CMAX
时间窗: 24 hours
Assess for bioequivalence at 325 mg and 650 mg dose levels CMAX of the metabolite salicylic acid
Bioequivalence of PL-ASA and Immediate Release Aspirin TMAX
时间窗: 24 hours
Assess for bioequivalence at 325 mg and 650 mg dose levels TMAX of the metabolite salicylic acid
Bioequivalence of PL-ASA and Immediate Release Aspirin AUC0-24
时间窗: 24 hours
Assess for bioequivalence at 325 mg and 650 mg dose levels AUC0-24 of the percent inhibition of serum Thromboxane B2
Bioequivalence of PL-ASA and Immediate Release Aspirin TMAX STB2
时间窗: 24 hours
Assess for bioequivalence at 325 mg and 650 mg dose levels TMAX of the percent inhibition of serum Thromboxane B2
次要结局
未报告次要终点