- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01939444
A Pilot Study of the Bioavailability of Nasal Naloxone
October 27, 2021 updated by: Norwegian University of Science and Technology
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Trondheim, Norway
- Department of circulation and medical imaging, NTNU
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: naloxone intranasal
2.0 mg by the nasal route
|
If bioavailability is 20% or 50 %, the dose will be equivalent to the clinical range 0.4 - 1.0 mg given parenterally
|
ACTIVE_COMPARATOR: naloxone intravenous
1.0 mg intravenous
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
preliminary bioavailability of nasal naloxone
Time Frame: 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.
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
time to maximum concentrations
Time Frame: 2 weeks
|
2 weeks
|
maximum concentration
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Øyvind Ellingsen, MD PhD, Norwegian University of Science and Technology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (ACTUAL)
October 1, 2014
Study Completion (ACTUAL)
November 1, 2014
Study Registration Dates
First Submitted
September 2, 2013
First Submitted That Met QC Criteria
September 5, 2013
First Posted (ESTIMATE)
September 11, 2013
Study Record Updates
Last Update Posted (ACTUAL)
November 3, 2021
Last Update Submitted That Met QC Criteria
October 27, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPI-12-001
- 2012-004989-18 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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