Naloxone Nasal Spray Pharmacokinetic Study

• Status: Unknown status
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mitovie Pharma Ltd
• Treatments: Naloxone; Pharmaceutical Solutions

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.