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A Pilot Study of the Bioavailability of Nasal Naloxone

N

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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