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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 Absorption and Bioavailability of CTx-1301 (Dexmethylphenidate)

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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 Absorption and Bioavailability of CTx-1301 (Dexmethylphenidate)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 16 Jul 2025

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At a glance

  • Drugs Dexmethylphenidate (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Pharmacokinetics
  • Acronyms Fed-Fast
  • Sponsors Cingulate Therapeutics

Most Recent Events

  • 09 Jul 2025 According to a Cingulate Therapeutics media release, the company appoints Nilay Patel as chief legal officer to support growth ahead of New Drug Application planned to submit to the FDA in coming weeks.
  • 29 Apr 2025 Positive top-line results presented in the Cingulate Therapeutics media release.
  • 03 May 2023 According to a Cingulate Therapeutics media release, assuming positive clinical results from the Phase 3 trials, Cingulate plans to submit a New Drug Application (NDA) for CTx-1301 in mid-2024 under the Section 505(b)(2) pathway.

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