Clinical Study to Investigate the Pharmacokinetics of Multiple Repeated Doses of Intranasal Naloxone

PHASE1CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

March 1, 2021

Primary Completion Date

March 20, 2021

Study Completion Date

March 20, 2021

Conditions
Healthy SubjectsOpioid AntagonistPharmacokinetics
Interventions
DRUG

Four naloxone nasal spray doses (1 every 2.5 min)

Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min

DRUG

Four naloxone nasal spray doses (2 every 2.5 min)

Four 4 mg IN naloxone doses (left and right nostrils at 0 min, left and right nostrils at 2.5 min)

DRUG

Two naloxone nasal spray doses (1 every 2.5 min)

Two 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min)

Trial Locations (1)

53095

Spaulding Clinical Research, West Bend

All Listed Sponsors
collaborator

Spaulding Clinical Research LLC

OTHER

lead

Food and Drug Administration (FDA)

FED

NCT04764630 - Clinical Study to Investigate the Pharmacokinetics of Multiple Repeated Doses of Intranasal Naloxone | Biotech Hunter | Biotech Hunter