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A Phase 1, Randomized, Open-Label, Single Dose, Two Sequence, Crossover, Relative Bioavailability and Taste Test Study of ATI-1501 in Healthy Adult Volunteers

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Trial Profile

A Phase 1, Randomized, Open-Label, Single Dose, Two Sequence, Crossover, Relative Bioavailability and Taste Test Study of ATI-1501 in Healthy Adult Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 16 Nov 2023

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At a glance

  • Drugs Metronidazole (Primary) ; Metronidazole
  • Indications Clostridium difficile infections
  • Focus Pharmacokinetics; Registrational
  • Sponsors Appili Therapeutics

    • Most Recent Events

    • 13 Nov 2023 According to an Appili Therapeutics media release, Appili anticipates receiving royalty and milestone payments from its partner Saptalis, based on LIKMEZ NDA approval and commercialization
    • 08 Feb 2023 According to an Appili Therapeutics media release, the Food and Drug Administration ("FDA") accepted the ATI-1501 New Drug Application ("NDA"). The FDA established a Prescription Drug User Fee ("PDUFA") action date of September 23, 2023.
    • 10 Nov 2022 According to an Appili Therapeutics media release, the company remain on track to seek FDA approval by the end of 2023 for ATI-1501.

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