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Intranasal (Optinose Bidirectional Nose-to-brain Device) Versus Intravenous Slow Infusion of Oxytocin - a Randomized, Placebo- Controlled Double-blind, Double-dummy 4-period Cross-over Study in Healthy Adult Volunteers Evaluating Brain Functional Magnetic Resonance Imaging Changes, Cognitive Response, Heart Rate Variability, Plasma Pharmacokinetics and Saliva Concentration After Single-dose Oxytocin 8 or 24 International Units (IU) Intranasally or 1 IU as Slow Intravenous Infusion

Trial Profile

Intranasal (Optinose Bidirectional Nose-to-brain Device) Versus Intravenous Slow Infusion of Oxytocin - a Randomized, Placebo- Controlled Double-blind, Double-dummy 4-period Cross-over Study in Healthy Adult Volunteers Evaluating Brain Functional Magnetic Resonance Imaging Changes, Cognitive Response, Heart Rate Variability, Plasma Pharmacokinetics and Saliva Concentration After Single-dose Oxytocin 8 or 24 International Units (IU) Intranasally or 1 IU as Slow Intravenous Infusion

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Oxytocin (Primary) ; Oxytocin (Primary)
  • Indications Autistic disorder
  • Focus Pharmacodynamics
  • Sponsors OptiNose
  • Most Recent Events

    • 06 Oct 2015 Initial results published in the peer-reviewed journal Translational Psychiatry, as per Optinose media release.
    • 15 Jul 2015 Results published in an OptiNose media release.
    • 22 Nov 2013 New trial record
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