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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

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Trial Profile

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 of Trial: Phase I

Latest Information Update: 29 Apr 2022

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At a glance

  • Drugs Aspirin (Primary) ; Aspirin
  • Indications Cardiovascular disorders; Pain
  • Focus Pharmacokinetics; Registrational
  • Sponsors PLx Pharma

Most Recent Events

  • 27 Apr 2022 Status changed from recruiting to completed.
  • 01 Mar 2021 According to a PLx Pharma media release, U.S. Food and Drug Administration (FDA) approved supplemental new drug applications (sNDAs) for its lead products, VAZALORE 325 mg and VAZALORE 81 mg (referred to together as VAZALORE), the first ever novel, liquid-filled aspirin capsule.
  • 16 Nov 2020 According to a PLx Pharma media release, the 325 mg sNDA provided information on a change in formulation and a new manufacturing site for the currently approved VAZALORE and also contains a bioequivalence clinical study report with the required data and analyses from the BE study. The submission for the 81 mg dose provided for a new product strength of VAZALORE and builds off the information in the original approved NDA (New Drug Application) and the recent sNDA submitted for VAZALORE 325 mg. Th

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