NCT04008979

Pharmacokinetic and Pharmacodynamic Assessment of a Novel, Pharmaceutical Lipid-Aspirin Complex

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: PLx Pharma · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

Prospective, Randomized, Crossover, Bioequivalence study

Detailed description

Active-control crossover study randomizing 32 healthy volunteers to receive one of two dose levels, 325 mg or 650 mg, of either PL-ASA or immediate release aspirin within a two week washout period between treatments. The primary objectives are to assess PK and PD bioequivalence and safety over a twenty four hour period for PL-ASA and immediate release aspirin at 325 mg and 650 mg dose strengths.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Aspirin	Aspirin - lipid complex

Timeline

• Start date: 2008-02-11
• Primary completion: 2008-06-10
• Completion: 2008-06-10
• First posted: 2019-07-05
• Last updated: 2019-07-05

Regulatory

• FDA-regulated drug study