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A Pilot Study of the Bioavailability of Nasal Naloxone

NCT01939444 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2021-11-03

No results posted yet for this study

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

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

Sponsors & Collaborators

  • St. Olavs Hospital

    collaborator OTHER

  • University of Iceland

    collaborator OTHER

  • Norwegian University of Science and Technology

    lead OTHER

Principal Investigators

  • Øyvind Ellingsen, MD PhD · Norwegian University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-10-31
Completion
2014-11-30

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01939444 on ClinicalTrials.gov