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

NCT03827642 · 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 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

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.

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
2018-04-23
Primary Completion
2018-05-06
Completion
2018-05-06
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 NCT03827642 on ClinicalTrials.gov