Pharmacodynamic and Pharmacokinetic Study of PL-ASA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-28

Study Completion Date

2021-09-15

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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PL-ASA capsule, then EC-ASA tablet

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

Group Type OTHER

PL-ASA

Intervention Type DRUG

Pharmacologic profile of different aspirin formulations

EC-ASA tablet, then PL-ASA capsule

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

Group Type ACTIVE_COMPARATOR

PL-ASA

Intervention Type DRUG

Pharmacologic profile of different aspirin formulations

Interventions

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PL-ASA

Pharmacologic profile of different aspirin formulations

Intervention Type DRUG

Other Intervention Names

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Enteric-coated Aspirin (EC-ASA)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes