Status:
COMPLETED
Pharmacodynamic and Pharmacokinetic Study of PL-ASA
Lead Sponsor:
PLx Pharma
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04811625
Start Date
April 28 2021
End Date
September 15 2021
Last Update
April 25 2022
Active Locations (1)
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1
University of Florida C
Jacksonville, Florida, United States, 32209