Pharmacodynamic and Pharmacokinetic Study of PL-ASA

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04811625

Enrollment

Registered

2021-03-23

Start date

2021-04-28

Completion date

2021-09-15

Last updated

2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

DRUGPL-ASA

Pharmacologic profile of different aspirin formulations

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Acetylsalicylic acid and salicylic acid	24 hours after dosing	Presence of serum acetylsalicylic acid and salicylic acid

Secondary

Measure	Time frame	Description
Light transmittance aggregometry	24 hours after dosing	Effects on platelet function by light transmittance aggregometry

Other

Measure	Time frame	Description
Serum thromboxane B2	24 hours after dosing	ncidence of aspirin responsiveness among study participants, measured by Inhibition of serum thromboxane B2 and thromboxane B2 levels
Adverse effects	24 hours after dosing	Safety, as indicated by any adverse effects

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026