Pharmacodynamic and Pharmacokinetic Study of PL-ASA

PLx Pharma

Status and phase: Completed; Phase 4

Conditions: Healthy Volunteers

Treatments: Drug: PL-ASA

Study type: Interventional

Funder types: Industry

Identifiers

NCT04811625

PL-ASA-010

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

36 participants in 2 patient groups

PL-ASA capsule, then EC-ASA tablet

Other group

Description:

PL-ASA capsule 81 mg, then crossover to EC-ASA tablet 81 mg

Treatment:

Drug: PL-ASA

EC-ASA tablet, then PL-ASA capsule

Active Comparator group

Description:

EC-ASA tablet 81 mg, then crossover to PL-ASA capsule 81 mg

Treatment:

Drug: PL-ASA