A Pilot Study of the Bioavailability of Nasal Naloxone

Phase 2CompletedNCT01939444

Norwegian University of Science and Technology5 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Drug Overdose

Interventions

naloxone intranasalDRUG

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

naloxone intravenousDRUG

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of circulation and medical imaging, NTNU

Trondheim, Norway

Outcomes

Primary Outcomes

preliminary bioavailability of nasal naloxone

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.

Time frame: 2 weeks

Secondary Outcomes

time to maximum concentrations

Time frame: 2 weeks

maximum concentration

Time frame: 2 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.