Bioavailability of Nasal Naloxone and Injected Naloxone Compared

PHASE1CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2016

Conditions
Drug Overdose
Interventions
DRUG

Intranasal (IN) naloxone 1x

Administered as 100 μl 14.0 mg/ml (1.4 mg naloxone) by Aptar Unitdose device as one puff in one nostril

DRUG

Intranasal (IN) naloxone 2

Administered as 2x 100 μl 14 mg/ml (2.8 mg naloxone) by Aptar Unitdose device as two puffs within the same nostril with 3 minutes interval

DRUG

Intravenous (IV) naloxone

Administered as 1 ml Naloxon B Braun 0.4 mg/ml (0.4 mg naloxone), in an intravenous cannula in the opposite arm of which the blood samples are drawn from. IV bolus will be given rapidly (in less than 5 seconds)

DRUG

Intramuscular (IM) naloxone

Naloxone administered as 2 ml Naloxon B Braun 0.4 mg/ml (0.8 mg naloxone) in a Braun Omnifix 2.5 ml syringe using a BD Microlance 3 21G (green) 0.8x40 mm needle in the deltoid muscle of the non-dominant arm

Trial Locations (1)

Unknown

Department of Circulation and Medical Imaging, Trondheim

All Listed Sponsors
collaborator

St. Olavs Hospital

OTHER

collaborator

A/S Den norske Eterfabrikk

INDUSTRY

collaborator

Smerud Medical Research International AS

OTHER

lead

Norwegian University of Science and Technology

OTHER

NCT02598856 - Bioavailability of Nasal Naloxone and Injected Naloxone Compared | Biotech Hunter | Biotech Hunter