Exploratory Bioavailability of Fentanyl Sublingual Spray Under Fasting Conditions

NACompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

January 31, 2014

Study Completion Date

January 31, 2014

Conditions
Bioavailability
Interventions
DRUG

Fentanyl Sublingual Spray (FSS)

A single dose of fentanyl, 400 mcg per sublingual spray

DRUG

Fentanyl Citrate Injection (FCI)

A single dose of fentanyl citrate, 100 mcg per intramuscular injection

DRUG

Naltrexone

Naltrexone is provided as a 50 mg tablet before and after product dosing to minimize unacceptable adverse effects of fentanyl.

Trial Locations (1)

78217

Worldwide Clinical Trials Early Phase Services, LLC, San Antonio

Sponsors
All Listed Sponsors
lead

INSYS Therapeutics Inc

INDUSTRY