Pharmacokinetic Evaluation of a New Naloxone Nasal Swab, Naloxone Nasal Spray, and Intramuscular Naloxone Injection in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

January 21, 2021

Primary Completion Date

April 3, 2022

Study Completion Date

April 11, 2022

Conditions
Opioid Overdose
Interventions
DRUG

IM Naloxone Injection

Single 0.4 mg IM naloxone injection will be administered (1 mL of 0.4 mg/mL injection, into the gluteus maximus muscle using a 23-gauge needle).

DRUG

Naloxone Nasal Spray

Single 4 mg intranasal naloxone spray will be administered in one nostril (0.1 mL of 4 mg/0.1 mL spray, based on the prescribing information and approved Instructions for Use).

DRUG

Naloxone Nasal Swab

4 mg naloxone nasal swab administered in nostril

DRUG

Naloxone Nasal Swab

8 mg naloxone nasal swab administered in nostril

DRUG

Naloxone Nasal Swab

12 mg naloxone nasal swab administered in nostril

DRUG

Naloxone Nasal Swab

12.5 mg naloxone nasal swab administered in nostril

Trial Locations (1)

Unknown

Altasciences, Québec

All Listed Sponsors
lead

Pocket Naloxone Corp

INDUSTRY

NCT05363501 - Pharmacokinetic Evaluation of a New Naloxone Nasal Swab, Naloxone Nasal Spray, and Intramuscular Naloxone Injection in Healthy Volunteers | Biotech Hunter | Biotech Hunter