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Clinical trial

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

NCT01983514 is registered in ClinicalTrials.gov with OptiNose AS as lead sponsor.

NCT NCT01983514
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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
OptiNose AS
Phase
Phase 1
Overall status
Completed
Start date
October 31, 2013
Completion date
February 28, 2014
Enrollment
19 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

healthy male adults