A Pilot Study of the Bioavailability of Nasal Naloxone

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital; University of Iceland
• Treatments: Naloxone

Criteria

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