Pharmacodynamic and Pharmacokinetic Study of PL-ASA

• Status: Active, not recruiting
• Trial end date: 2021-10-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: PLx Pharma
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• Male or female non-smoking subjects between the ages of 50 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

Exclusion Criteria:

• 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