NCT01622504

Naloxone Nasal Spray Pharmacokinetic Study

A Phase I Single Dose, Open Label, Randomized, Three Period Crossover Pilot Study to Compare the Pharmacokinetics, Safety and Tolerability of MVP005 Intranasal Spray With Intranasal Administration of Naloxone Solution for Injection in Healthy Adult Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Mitovie Pharma Ltd · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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).

Detailed description

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

• Opioid Overdose

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-06-01
• Primary completion: 2012-07-01
• Completion: 2012-08-01
• First posted: 2012-06-19
• Last updated: 2012-06-20

Locations

1 site across 1 country: Jordan