A Pilot Study of the Bioavailability of Nasal Naloxone

Norwegian University of Science and Technology

Status and phase: Completed; Phase 2

Conditions: Drug Overdose

Treatments: Drug: naloxone intranasal; Drug: naloxone intravenous

Study type: Interventional

Funder types: Other

Identifiers

NCT01939444

2012-004989-18 (EudraCT Number)

OPI-12-001

Details and patient eligibility

About

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

Enrollment: 5 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

naloxone intranasal

Experimental group

Description:

2.0 mg by the nasal route

Treatment:

Drug: naloxone intranasal

naloxone intravenous

Active Comparator group

Description:

1.0 mg intravenous

Treatment:

Drug: naloxone intravenous