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An open-label, randomized, single-dose, two-period, two-treatment (Fed vs. Fasted), two-sequence, crossover study In Healthy adult subjects to assess the effect of food on the bioavailability of CTx-1301 (dexmethylphenidate) of the highest dose

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Trial Profile

An open-label, randomized, single-dose, two-period, two-treatment (Fed vs. Fasted), two-sequence, crossover study In Healthy adult subjects to assess the effect of food on the bioavailability of CTx-1301 (dexmethylphenidate) of the highest dose

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 23 Sep 2024

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At a glance

  • Drugs Dexmethylphenidate (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Pharmacokinetics; Registrational

    • Most Recent Events

    • 23 Sep 2024 New trial record
    • 12 Sep 2024 According to a Cingulate Therapeutics media release, NDA submission for CTx-1301, is targeted for mid 2025.
    • 12 Sep 2024 According to a Cingulate Therapeutics media release, the company has commenced its final FDA-required study, which is a food effect study, for CTx-1301. A data readout from the study is expected by the end of 2024.

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