Fentanyl Sublingual Spray and Fentanyl Citrate Intravenous (IV) in Opioid Naive Subjects

Phase 1 Completed 50 enrolled INSYS Therapeutics Inc

RandomizedParallel-groupOpen-labelBasic science

Summary

The primary objective of this study is to determine the pharmacokinetic and pharmacodynamic relationship of a single dose of fentanyl sublingual spray in opioid naive subjects. The secondary objective is to determine the safety and tolerability of fentanyl sublingual spray in opioid naive subjects.

Timeline

Start: 2015-10
Primary completion: 2015-11
Completion: 2015-11

Publications

Rauck R, Oh DA, Parikh N, Koch C, Singla N, Yu J, Nalamachu S, Vetticaden S. Pharmacokinetics and safety of fentanyl sublingual spray and fentanyl citrate intravenous: a single ascending dose study in opioid-naive healthy volunteers. Curr Med Res Opin. 2017 Nov;33(11):1915-1920. doi: 10.1080/03007995.2017.1352496. Epub 2017 Aug 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fentanyl	Other / unclassified	50 ug	Other
Subject	Fentanyl	Other / unclassified	50 ug	Intravenous
Subject	Fentanyl	Other / unclassified	100 ug	Other
Subject	Fentanyl	Other / unclassified	200 ug	Other
Subject	Fentanyl	Other / unclassified	400 ug	Other
Subject	Fentanyl	Other / unclassified	600 ug	Other
Subject	Fentanyl	Other / unclassified	800 ug	Other

Indications

No indication recorded.