NCT05055752

Randomized, Crossover Bioequivalence Study of PL-ASA Versus Immediate Release Aspirin in Healthy Volunteers.

A Randomized, Actively-Controlled, Crossover Bioequivalence Study of a Novel Pharmaceutical Lipid-Aspirin Complex Formulation at 325 mg Dose Versus Immediate Release Aspirin in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: PLx Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This trial is a randomized, actively-controlled, open-label, 2-way crossover bioequivalence study to determine PK parameters following treatment with test aspirin product (PL-ASA capsules) and reference aspirin product (IR-ASA tablets) administered at a single dose of 325 mg.

Detailed description

Healthy volunteers will be asked to sign informed consent prior to conduct any protocol specified activities at screening. A total of 20 eligible subjects will be randomized, in a fasted state, to 1 of 2 sequences of study drug administration (each study drug dose contains 325 mg aspirin) at 1:1 ratio: * PL-ASA capsule, IR-ASA tablet * IR-ASA tablet, PL-ASA capsule After completion of the first treatment on Day 1 and following the 24 hours of sample collection, a minimum of a 7-day washout period will be required before all subjects are crossed over and receive treatment with the alternative compound; i.e., subject randomized to receive PL-ASA capsule as a first treatment will receive IR-ASA tablet as the second treatment, and vice-versa.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Pharmaceutical-lipid aspirin (PL-ASA)	Subjects receive the first drug, followed by a 7-day washout period, then receive the second drug.

Timeline

• Start date: 2020-05-07
• Primary completion: 2020-06-29
• Completion: 2020-10-01
• First posted: 2021-09-24
• Last updated: 2022-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study