NCT02572089

Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers

Phase 1, Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To determine the pharmacokinetics of 4 intranasal doses of naloxone compared to a 0.4 mg dose of naloxone administrated intramuscular and to identify an appropriate intranasal dose that could achieve systemic exposure comparable to an approved parenteral dose. To also determine the pharmacokinetics of two different concentrations of intranasal naloxone and finally, to determine the safety of intranasal naloxone with respect to nasal irritation.

Conditions

• Drug Overdose
• Opioid-Related Disorders

Interventions

Type	Name	Description
DRUG	Naloxone

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2015-10-08
• Last updated: 2017-01-12

Locations

1 site across 1 country: United States