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A an open-label, single-dose, 4-treatment, 4-period, randomized, crossover, Phase 1 clinical trial to assess the relative cardiovascular safety of serdexmethylphenidate (SDX) compared to immediate-release and long-acting formulations of Ritalin (racemic methylphenidate), a commonly prescribed CNS stimulant in healthy volunteers

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Trial Profile

A an open-label, single-dose, 4-treatment, 4-period, randomized, crossover, Phase 1 clinical trial to assess the relative cardiovascular safety of serdexmethylphenidate (SDX) compared to immediate-release and long-acting formulations of Ritalin (racemic methylphenidate), a commonly prescribed CNS stimulant in healthy volunteers

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 13 Sep 2023

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At a glance

  • Drugs Serdexmethylphenidate (Primary) ; Methylphenidate; Methylphenidate
  • Indications Attention-deficit hyperactivity disorder; Substance-related disorders
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Zevra Therapeutics

    • Most Recent Events

    • 09 Sep 2023 According to a KemPharm media release, data from this study were presented at the Psych Congress 2023.
    • 09 Sep 2023 Results presented in a KemPharm media release.
    • 22 Feb 2023 According to a KemPharm media release, KemPharm has changed its name to Zevra Therapeutics.

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