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A single-center open-label relative bioavailability and dose proportionality Study of AD04 healthy adult volunteers and compare the pharmacokinetic profile of AD04 when administered as an oral dose with or without food against a reference standard product

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Trial Profile

A single-center open-label relative bioavailability and dose proportionality Study of AD04 healthy adult volunteers and compare the pharmacokinetic profile of AD04 when administered as an oral dose with or without food against a reference standard product

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 15 May 2025

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At a glance

  • Drugs Ondansetron (Primary)
  • Indications Alcoholism
  • Focus Pharmacokinetics

Most Recent Events

  • 08 May 2025 According to Adial Pharmaceuticals media release, the FDA has granted request for an End of Phase 2 meeting to discuss Adial's proposed clinical development plan and seek FDA guidance on the Phase 3 adaptive with enrichment design of the upcoming clinical trial for AD04. The meeting will take place on July 25, 2025.
  • 04 Mar 2025 According to Adial Pharmaceuticals media release, positive feedback from the U.S. Food and Drug Administration (FDA) regarding our proposed 505(b)(2) bridging strategy and the initiation of clinical supply manufacturing for our upcoming Phase 3 trial this year
  • 29 Jan 2025 According to an Adial Pharmaceuticals media release, results from this study support the near micro-dosing regimen planned for use in the upcoming registration trials for AD04 and conform with the FDA bridging requirements for a 505(b)(2) registration pathway.

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