Naloxone Nasal Spray Pharmacokinetic Study

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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-08-31

Brief Summary

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This study aims to compare the pharmacokinetics of naloxone when administered as the Mitovie nasal spray (Test Product) and as a solution for injection (Comparator Product) administered intranasally using a mucosal atomization device (MAD).

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Detailed Description

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Naloxone hydrochloride is currently only recommended and licensed for intravenous, intramuscular and subcutaneous administration. It has also been used by intranasal administration (off-label use) when the intravenous route is not suitable by administering the Solution for Injection using a mucosal atomization device (MAD). However, due to the volume of naloxone solution administered this way, some of it may be inadvertently swallowed and not absorbed into the nasal mucosa and the product requires administration by medically trained personnel. The study aims to investigate intranasal administration of naloxone using a more concentrated solution and a nasal delivery device.

Conditions

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Opioid Overdose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Test Product Dose 1

Group Type EXPERIMENTAL

MVP005

Intervention Type DRUG

2 mg single dose administered intranasally

Test Product Dose 2

Group Type EXPERIMENTAL

MVP005

Intervention Type DRUG

4 mg single dose administered intranasally

Comparator Product

Group Type ACTIVE_COMPARATOR

Naloxone hydrochloride solution for injection with mucosal atomization device

Intervention Type DRUG

2 mg single dose administered intranasally

Interventions

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MVP005

2 mg single dose administered intranasally

Intervention Type DRUG

MVP005

4 mg single dose administered intranasally

Intervention Type DRUG

Naloxone hydrochloride solution for injection with mucosal atomization device

2 mg single dose administered intranasally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female
* 18-60 50 years of age
* Provide written informed consent prior to completing any study specific procedure.
* Body Mass Index (BMI) range 18.5-30 kg/m2
* Clinically acceptable medical history, clinical laboratory evaluations, complete physical examination, vital signs and 12 lead ECG
* Using reliable contraception

Exclusion Criteria

* Intranasal problems
* Taking prescribed or over the counter medications
* Intake of alcohol, methyl-xanthines or grapefruit or strenuous exercise concurrent with treatment.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes