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A single-center, Phase 1, randomized, double-blind, placebo-controlled, single-dose, 5-way crossover, Human Abuse Potential Trial of Oral Serdexmethylphenidate

Trial Profile

A single-center, Phase 1, randomized, double-blind, placebo-controlled, single-dose, 5-way crossover, Human Abuse Potential Trial of Oral Serdexmethylphenidate

Completed
Phase of Trial: Phase I

Latest Information Update: 18 Jan 2019

At a glance

  • Drugs Serdexmethylphenidate (Primary) ; Methylphenidate; Phentermine
  • Indications Attention-deficit hyperactivity disorder
  • Focus Pharmacodynamics; Pharmacokinetics; Registrational
  • Sponsors KemPharm
  • Most Recent Events

    • 18 Jan 2019 According to a KemParma media release, data from this study will be presented at the 2019 Annual Meeting of the American Professional Society for ADHD and Related Disorders (APSARD).
    • 17 Sep 2018 According to a KemPharm media release, the company will present the data from all three HAP trials, as well as tampering study results, to the U.S. Food and Drug Administration (FDA) as part of its human abuse potential assessment for SDX in the KP415 New Drug Application (NDA). The NDA filing is anticipated as early as the first quarter of 2019.
    • 17 Sep 2018 Results presented in a KemPharm media release.
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