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Completed

NCT Number: NCT01939444

A Pilot Study of the Bioavailability of Nasal Naloxone

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

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Key information

Conditions

Drug Overdose Chemically-Induced Disorders Drug Misuse Mental Disorders Prescription Drug Misuse Substance-Related Disorders

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Department of circulation and medical imaging, NTNU

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy (adequate organ function is determined by electrocardiogram (ECG), liver and kidney clinical chemistry, and a standard clinical examination/interview. For safety reasons we may ask for urine sample for analysis of opioids)
  • informed consent

Exclusion criteria

  • history of liver disease
  • taking any medications including herbal medicines the last week history of drug abuse
  • any local nasal disease or nasal surgery or recent cold for the last week
  • any history of drug allergies

Treatment and study plan

naloxone intranasal

Drug

If bioavailability is 20% or 50 %, the dose will be equivalent to the clinical range 0.4 - 1.0 mg given parenterally

naloxone intravenous

Drug

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

Primary outcomes

  1. preliminary bioavailability of nasal naloxone

    Time frame: 2 weeks

    measured as ratio of area under the time concentration curve for nasal over intravenous naloxone x 100. Plasma concentration data will be analyzed by non-compartmental techniques.

Secondary outcomes

  1. time to maximum concentrations

    Time frame: 2 weeks

  2. maximum concentration

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital
  • University of Iceland

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 11, 2013
Registry last updated
Nov 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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