NCT02138396

Exploratory Bioavailability of Fentanyl Sublingual Spray Under Fasting Conditions

Single-Dose, Open-Label, Two-Period, Two-Treatment, Two-Sequence Crossover Exploratory Bioavailability Study of Subsys® (Fentanyl Sublingual Spray), 400 mcg, and Fentanyl Citrate Injection 2 mL x 0.05 mg/mL (Total Dose 100 mcg) Under Fasted Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: INSYS Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the rate of absorption and bioavailability of fentanyl sublingual spray 400 mcg to fentanyl citrate 100 mcg by intramuscular injection.

Conditions

• Bioavailability

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2014-05-14
• Last updated: 2014-12-12

Locations

1 site across 1 country: United States