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Naloxone Nasal Spray Pharmacokinetic Study

NCT01622504 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2012-06-20

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

MVP005

2 mg single dose administered intranasally

DRUG

MVP005

4 mg single dose administered intranasally

DRUG

Naloxone hydrochloride solution for injection with mucosal atomization device

2 mg single dose administered intranasally

Sponsors & Collaborators

  • Mitovie Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Abdullah Hiyari, MD · IPRC, Jordan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2012-07-31
Completion
2012-08-31

Countries

  • Jordan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01622504 on ClinicalTrials.gov