A Pilot Study of the Bioavailability of Nasal Naloxone

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01939444

Enrollment

Registered

2013-09-11

Start date

2013-08-31

Completion date

2014-11-30

Last updated

2021-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Overdose

Keywords

Antidotes, naloxone, administration, intravenous, administration, intranasal, pharmacology

Brief 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

Interventions

DRUGnaloxone intranasal

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

DRUGnaloxone 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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
preliminary bioavailability of nasal naloxone	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

Measure	Time frame
time to maximum concentrations	2 weeks
maximum concentration	2 weeks

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026