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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: 23 Jun 2025

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At a glance

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

Most Recent Events

  • 16 Jun 2025 According to Adial Pharmaceuticals media release, company announced the submission of the required briefing package for the upcoming End of Phase 2 meeting (EOP2M) with the FDA. The FDA has rescheduled the meeting which will now be held on July 29th. The objective for the EOP2M is to align with the FDA on the design of the Phase 3 Clinical Development program for AD04.
  • 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

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