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A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Powder

NCT04713709 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2022-05-02

No results posted yet for this study

Summary

A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Nasal Powder.

Conditions

Interventions

COMBINATION_PRODUCT

Nasus Pharma FMXIN001

A nasal spray of 4mg Naloxone Hydrochloride powder in a unit dose device

COMBINATION_PRODUCT

Nasal Naloxone liquid spray

A nasal spray of 4mg/0.1mL Naloxone Hydrochloride solution in a unit dose device

Sponsors & Collaborators

  • Nasus Pharma

    lead INDUSTRY

Principal Investigators

  • Janice Faulknor, MD, CCFP · Pharma Medica Research Inc. Canada

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-31
Primary Completion
2021-03-30
Completion
2021-10-10
FDA Drug
Yes
FDA Device
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT04713709 on ClinicalTrials.gov