A Pilot Study of the Bioavailability of Nasal Naloxone

Phase 2

Completed

• Conditions: Drug Overdose
• Interventions: Drug: naloxone intranasal; Drug: naloxone intravenous

• Registration Number: NCT01939444
• Lead Sponsor: Norwegian University of Science and Technology

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-09-02
• Study First Submitted QC: 2013-09-05
• Study First Posted: 2013-09-11
• Primary Completion: 2014-10
• Study Completion: 2014-11
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
naloxone intranasal	naloxone intranasal	2.0 mg by the nasal route
naloxone intravenous	naloxone intravenous	1.0 mg intravenous

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
time to maximum concentrations	2 weeks
maximum concentration	2 weeks

Trial Locations

Locations (1)

Department of circulation and medical imaging, NTNU; 🇳🇴 Trondheim, Norway