Pharmacodynamic and Pharmacokinetic Study of PL-ASA
- Registration Number
- NCT04811625
- Lead Sponsor
- PLx Pharma
- 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 single dose of 81 mg among the volunteers aged 50 to 75 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- 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 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description PL-ASA capsule, then EC-ASA tablet PL-ASA PL-ASA capsule 81 mg, then crossover to EC-ASA tablet 81 mg EC-ASA tablet, then PL-ASA capsule PL-ASA EC-ASA tablet 81 mg, then crossover to PL-ASA capsule 81 mg
- Primary Outcome Measures
Name Time Method Acetylsalicylic acid and salicylic acid 24 hours after dosing Presence of serum acetylsalicylic acid and salicylic acid
- Secondary Outcome Measures
Name Time Method Light transmittance aggregometry 24 hours after dosing Effects on platelet function by light transmittance aggregometry
Trial Locations
- Locations (1)
University of Florida C
🇺🇸Jacksonville, Florida, United States