Pharmacokinetic and Pharmacodynamic Assessment of a Novel, Pharmaceutical Lipid-Aspirin Complex
- Registration Number
- NCT04008979
- Lead Sponsor
- PLx Pharma
- Brief Summary
Prospective, Randomized, Crossover, Bioequivalence study
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- 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.
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Subject has abnormal screening/baseline laboratory parameters deemed to be clinically significant by the Investigator.
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Subject has taken any prescription medications other than hormone replacement therapy or thyroid replacement hormones within 3 days prior to drug administration.
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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
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Subject has used an investigational agent within the past 30 days.
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Subject has hypersensitivity or contraindications to aspirin, ibuprofen, or other NSAID.
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Subject has sensitivity to lecithin.
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Subject has a history of gastrointestinal problems including ulcers, frequent indigestion, or heartburn.
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Subject has a history of stroke, myocardial infarction, or congestive heart failure.
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Subject has a history of asthma, other bronchospastic activity, nasal polyps, or angioedema other than resolved childhood asthma.
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Subject has a history of kidney or liver disease.
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Subject has a history of thrombocytopenia, neutropenia, or bleeding disorder.
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Subject has a history of coronary arterial bypass.
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Subject has a history of non-trauma related hemorrhage.
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Subject has a history of chronic hypertension.
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Subject is currently enrolled in another investigational trial.
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Subject's platelets are unresponsive to arachidonic acid
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description IR 325 mg Aspirin Immediate release aspirin IR 650 Aspirin Immediate release aspirin PL-ASA-650 Aspirin Novel aspirin formulation being tested PL-ASA 325 mg Aspirin Novel aspirin formulation being tested
- Primary Outcome Measures
Name Time Method Bioequivalence of PL-ASA and Immediate Release Aspirin AUC0-T 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-∞ 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 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 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 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 24 hours Assess for bioequivalence at 325 mg and 650 mg dose levels TMAX of the percent inhibition of serum Thromboxane B2
- Secondary Outcome Measures
Name Time Method