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COMPLETED
NCT05377255
PHASE1

Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults

Sponsor: Emergent BioSolutions

View on ClinicalTrials.gov

Summary

This study will be a Phase 1, single-center, open-label, randomized cross-over study to evaluate the PK of a new AP003 device which delivers two sprays of 4 mg naloxone hydrochloride intranasally.

Official title: A Phase 1, Open Label, Randomized Study to Investigate the Pharmacokinetics and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adult Participants

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2022-03-28

Completion Date

2022-05-10

Last Updated

2026-04-15

Healthy Volunteers

Yes

Conditions

Interventions

COMBINATION_PRODUCT

16 mg naloxone AP003

4 doses of 4 mg each (total: 16 mg) of naloxone through the AP003 device

COMBINATION_PRODUCT

8 mg naloxone NARCAN Nasal Spray

2 doses of 4 mg each (total: 8 mg) of the naloxone through the NARCAN Nasal Spray device

Locations (1)

Syneos Health Clinical Research Services

Miami, Florida, United States