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A Randomized, Double-Blind, Double-Dummy, Placebo-, Active-Controlled, 4 Period, 4 Way Crossover Study to Evaluate the Abuse Potential of Manipulated Abuse-Deterrent Dextroamphetamine Sulfate Immediate Release (ADAIR) Formulation Compared to Dextroamphetamine Sulfate Immediate Release When Administered Intranasally to Nondependent, Recreational Stimulant Users

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Trial Profile

A Randomized, Double-Blind, Double-Dummy, Placebo-, Active-Controlled, 4 Period, 4 Way Crossover Study to Evaluate the Abuse Potential of Manipulated Abuse-Deterrent Dextroamphetamine Sulfate Immediate Release (ADAIR) Formulation Compared to Dextroamphetamine Sulfate Immediate Release When Administered Intranasally to Nondependent, Recreational Stimulant Users

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 24 Aug 2023

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At a glance

  • Drugs Dexamfetamine (Primary) ; Dexamfetamine (Primary) ; Dexamfetamine
  • Indications Attention-deficit hyperactivity disorder; Narcolepsy
  • Focus Pharmacodynamics; Registrational
  • Acronyms SEAL
  • Sponsors GRI Bio; Vallon Pharma

Most Recent Events

  • 12 May 2022 Additional pharmacokinetic and pharmacodynamic results published in the Vallon Pharma Media Release.
  • 21 Mar 2022 Primary endpoint (Drug Liking Emax Visual Analog Scale (VAS)) has not been met, according to a Vallon Pharma media release.
  • 21 Mar 2022 Results published in the Media Release

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