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A Phase 1b, open-label, three-treatment, three-way crossover, randomized controlled, weight-based dosing study of diazepam intramuscular (IM) injection compared to commercial diazepam rectal gel (Diastat)

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Trial Profile

A Phase 1b, open-label, three-treatment, three-way crossover, randomized controlled, weight-based dosing study of diazepam intramuscular (IM) injection compared to commercial diazepam rectal gel (Diastat)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 03 Aug 2020

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At a glance

  • Drugs Diazepam (Primary) ; Diazepam
  • Indications Epilepsy
  • Focus Pharmacokinetics

    • Most Recent Events

    • 30 Jul 2020 According to an XERIS Pharmaceuticals Media Release, FDA provided feedback that the drug development program for XP-0863 could advance directly into a Phase 3 registration study in both pediatric and adult patients with epilepsy.
    • 30 Jul 2020 According to an XERIS Pharmaceuticals Media Release, data were also presented to the U.S. Food and Drug Administration (FDA) during a recent end-of-Phase 1 interaction.
    • 30 Jul 2020 According to an XERIS Pharmaceuticals Media Release, in April data from this study was presented at the Fifteenth EILAT Conference on New Antiepileptic Drugs and Devices (EILAT XV).

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