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Bioavailability Study of Naloxone 5 Milligrams (mg) Intramuscular (IM) Autoinjector

NCT05264493 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2022-03-03

No results posted yet for this study

Summary

To compare the plasma concentration (bioavailability) and safety of a single naloxone 5 mg autoinjector intramuscular (IM) injection to a single 2 mg IM injection (an approved safe dose) and to a single 2 mg bolus intravenous (IV) injection (an approved safe dose)

Conditions

  • Healthy Volunteers

Interventions

DRUG

NaxRedy ™

5 mg (5 mg/0.5 mL) IM autoinjector injection into lateral thigh

DRUG

Naloxone Hydrochloride Injection, USP

2 mg IM (2mg/2 mL) injection into gluteal muscle

DRUG

Naloxone Hydrochloride Injection, USP

2 mg bolus IV (2mg/2 mL)

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2020-10-06
Primary Completion
2021-01-08
Completion
2021-01-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT05264493 on ClinicalTrials.gov