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A Pilot Study of the Bioavailability of Nasal Naloxone

NCT ID: NCT01939444

Last Updated: 2021-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Drug Overdose

Keywords

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Antidotes naloxone administration, intravenous administration, intranasal pharmacology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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naloxone intranasal

2.0 mg by the nasal route

Group Type EXPERIMENTAL

naloxone intranasal

Intervention Type DRUG

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

naloxone intravenous

1.0 mg intravenous

Group Type ACTIVE_COMPARATOR

naloxone intravenous

Intervention Type DRUG

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

Interventions

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naloxone intranasal

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

Intervention Type DRUG

naloxone 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

University of Iceland

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Øyvind Ellingsen, MD PhD

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

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Department of circulation and medical imaging, NTNU

Trondheim, , Norway

Site Status

Countries

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Norway

References

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Tylleskar I, Skulberg AK, Nilsen T, Skarra S, Dale O. Naloxone nasal spray - bioavailability and absorption pattern in a phase 1 study. Tidsskr Nor Laegeforen. 2019 Sep 23;139(13). doi: 10.4045/tidsskr.19.0162. Print 2019 Sep 24. English, Norwegian.

Reference Type RESULT
PMID: 31556537 (View on PubMed)

Other Identifiers

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2012-004989-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

OPI-12-001

Identifier Type: -

Identifier Source: org_study_id