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A randomized, single-dose, open-label, 4-period, 4-treatment crossover phase I study to investigate the pharmacokinetics of NT-0202 (Amfetamine XR-ODT) in presence of varying concentrations of alcohol

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A randomized, single-dose, open-label, 4-period, 4-treatment crossover phase I study to investigate the pharmacokinetics of NT-0202 (Amfetamine XR-ODT) in presence of varying concentrations of alcohol

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 04 Aug 2017

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At a glance

  • Drugs Amfetamine (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Adverse reactions; Pharmacokinetics; Registrational

    • Most Recent Events

    • 28 Jul 2017 Results published in the Clinical Therapeutics
    • 27 Jan 2016 According to a Neos Therapeutics media release, the US FDA has approved Adzenys XR-ODT (Amphetamine Extended-Release Orally Disintegrating Tablet) for the treatment of attention-deficit hyperactivity disorder (ADHD) in patients six years and older.
    • 03 Sep 2015 According to a Neos Therapeutics media release, the company received FDA acknowledgement of the resubmission of the new drug application (NDA) for NT0202 with a Prescription Drug User Fee Act (PDUFA) goal date of January 27, 2016.

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