Trial | NCT01622504  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    naloxone ...

  • Study Participants

    6
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).
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.
Study Started
Jun 30
2012
Primary Completion
Jul 31
2012
Anticipated
Study Completion
Aug 31
2012
Anticipated
Last Update
Jun 20
2012
Estimate

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

Test Product Dose 1 Experimental

Test Product Dose 2 Experimental

Comparator Product Active Comparator

Criteria 

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.
No Results Posted