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Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers

Opioid-Related Disorders Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02572089
Study type Interventional
Source National Institute on Drug Abuse (NIDA)
Contact
Status Completed
Phase Phase 1
Start date October 2014
Completion date January 2015
View Details
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