Pharmacokinetic and Pharmacodynamic Assessment of a Novel, Pharmaceutical Lipid-Aspirin Complex

• Status: Completed
• Trial end date: 2008-06-10
• Target enrollment: 0
• Participant gender: All

Summary

Prospective, Randomized, Crossover, Bioequivalence study

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: PLx Pharma
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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