Pharmacokinetic Study of Fentanyl 400 µg Sublingual Spray, Actiq® 400 µg Transmucosally, and Fentanyl Citrate Injection 100 µg Intravenously (iv)

Phase 1 Completed 40 enrolled INSYS Therapeutics Inc

RandomizedCrossoverOpen-labelTreatment

Summary

The objective of this study was to compare the rate of absorption and bioavailability of fentanyl 400 µg sublingual spray, Actiq® 400 µg transmucosally, and fentanyl citrate injection 100 µg intravenously.

Timeline

Start: 2007-04
Primary completion: 2007-05
Completion: 2007-05

Publications

Parikh N, Goskonda V, Chavan A, Dillaha L. Single-dose pharmacokinetics of fentanyl sublingual spray and oral transmucosal fentanyl citrate in healthy volunteers: a randomized crossover study. Clin Ther. 2013 Mar;35(3):236-43. doi: 10.1016/j.clinthera.2013.02.017.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fentanyl	Other / unclassified	100 ug	Other
Subject	Fentanyl	Other / unclassified	400 ug	Other
Background	Naltrexone	Small molecule	50 mg	Oral

Indications

No indication recorded.