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

NCT03827629 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-02-01

No results posted yet for this study

Summary

The main objective of this study is to compare early exposures of two test formulations of Naloxone Nasal Spray with the reference formulation of Naloxone HCl IM Injection under fasted conditions.

Conditions

  • Healthy Volunteer

Interventions

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 Intramuscular (IM) Injection

Participants received naloxone HCl IM injection following a 10 hour fast.

Sponsors & Collaborators

  • INSYS Therapeutics Inc

    lead INDUSTRY

Principal Investigators

  • Giovanni DeCastro · INSYS Therapeutics Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-07
Primary Completion
2017-08-16
Completion
2017-08-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03827629 on ClinicalTrials.gov