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Open-Label, Single-Center, Randomized, 2-way Crossover Study Evaluating Relative Bioavailability of OC-01 (Varenicline) Nasal Spray as Compared to Orally Administered Varenicline (the Zen Study)

Trial Profile

Open-Label, Single-Center, Randomized, 2-way Crossover Study Evaluating Relative Bioavailability of OC-01 (Varenicline) Nasal Spray as Compared to Orally Administered Varenicline (the Zen Study)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 25 May 2022

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At a glance

  • Drugs Varenicline (Primary) ; Varenicline
  • Indications COVID 2019 infections; Dry eyes; Neurotrophic keratopathy
  • Focus Pharmacokinetics
  • Acronyms ZEN
  • Sponsors Oyster Point Pharmaceuticals
  • Most Recent Events

    • 26 Aug 2021 Results published in the Clinical Therapeutics
    • 05 Aug 2020 According to an Oyster Point Pharma media release, based on this study and other two trials (ZEN and ONSET-1) the NDA submission is expected in the fourth quarter of 2020.
    • 05 Feb 2020 Status changed from active, no longer recruiting to completed.

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