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A Phase 1 Study to Determine the Single-dose Pharmacodynamics, Pharmacokinetics, and Safety and Tolerability of Remimazolam Following Oral Administration With and Without Alcohol in Healthy Female Subjects

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Trial Profile

A Phase 1 Study to Determine the Single-dose Pharmacodynamics, Pharmacokinetics, and Safety and Tolerability of Remimazolam Following Oral Administration With and Without Alcohol in Healthy Female Subjects

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 04 Nov 2021

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At a glance

  • Drugs Remimazolam (Primary) ; Alcohol
  • Indications Anaesthesia; Sedation
  • Focus Pharmacodynamics; Pharmacokinetics
  • Sponsors PAION

    • Most Recent Events

    • 05 Aug 2020 Status changed to discontinued.
    • 05 Aug 2020 Results from two trials (NCT04113564, NCT04113343) evaluate the bioavailability and pharmacokinetic/pharmacodynamic (PK/PD) profile of oral remimazolam, alone and in combination with alcohol, and to investigate the potential for misuse of oral administration of remimazolam published in the Drugs in R and D
    • 04 Oct 2019 New trial record

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