NCT01939444

A Pilot Study of the Bioavailability of Nasal Naloxone

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The overall is aim of this pilot study is to give a preliminary estimation of key parameters of the pharmacokinetics of a proper formulation of intranasal naloxone. These data will be used to design a well justified protocol for the final estimation of these parameters: * Preliminary estimation of bioavailability of this intranasal naloxone in human, healthy volunteers * Preliminary estimation of the maximum serum concentration (Cmax) of this formulation * Preliminary estimation of the time to maximum serum concentration (Tmax) of this formulation * Safety of the formulation

Conditions

• Drug Overdose

Interventions

Type	Name	Description
DRUG	naloxone intranasal	If bioavailability is 20% or 50 %, the dose will be equivalent to the clinical range 0.4 - 1.0 mg given parenterally
DRUG	naloxone intravenous	The parenteral dose reflects clinically used doses for overdoses (0.4 - 1.0 mg). A washout period of at least 3 days between each intervention. IV naloxone (Naloxone B. Braun 0.4mg/ml) administered slowly over 1-2 min in the recumbent position

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-10-01
• Completion: 2014-11-01
• First posted: 2013-09-11
• Last updated: 2021-11-03

Locations

1 site across 1 country: Norway