NCT03827642

A Study to Compare Bioavailability of Naloxone Nasal Spray, Naloxone Hydrochloride (HCl) Intravenous (IV) and Intramuscular Injection (IM) in Healthy Volunteers

A Phase 1, Open-Label, Randomized, Crossover, Comparative Bioavailability Study of Naloxone Nasal Spray and Naloxone Hydrochloride Intravenous and Intramuscular Injection in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: INSYS Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The main objective of this study was to compare the bioavailability of two test formulations of Naloxone Nasal Spray with the reference formulations of Naloxone HCl IV and IM injection under fasted conditions.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Treatment A: Naloxone Nasal Spray	Participants received naloxone nasal spray following a 10 hour fast.
DRUG	Treatment B: Naloxone Nasal Spray	Participants received naloxone nasal spray following a 10 hour fast.
DRUG	Treatment C: Naloxone HCl Intravenous (IV) Injection	Participants received naloxone HCl IV injection following a 10 hour fast.
DRUG	Treatment D: Naloxone HCl Intramuscular (IM) Injection	Participants received naloxone HCl IM injection following a 10 hour fast.

Timeline

• Start date: 2018-04-23
• Primary completion: 2018-05-06
• Completion: 2018-05-06
• First posted: 2019-02-01
• Last updated: 2019-02-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study