Pharmacokinetic Characterization of the Active, Separated System With PK Controller (Fentanyl Iontophoretic Transdermal System, 40 Mcg Fentanyl Per Activation).

Phase 1 Completed 54 enrolled Incline Therapeutics, Inc.

RandomizedSingle-groupOpen-label

Summary

"This study is a single-center, randomized, open-label, 3-period, 5-treatment, 6-sequence design. A total of 54 eligible subjects will receive three total treatments; one with intravenous (IV) infusion and two with the Study System. Each subject will be randomly assigned to receive a treatment sequence consisting of Treatment A (IV fentanyl citrate), Study System Treatment B (170 mcAmp), and one of three additional Study System treatments (140 mcAmp or 200 mcAmp or 230 mcAmp) "

Timeline

Start: 2012-12
Primary completion: 2013-03
Completion: 2013-03

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fentanyl	Other / unclassified	35 ug	Intravenous
Subject	Fentanyl	Other / unclassified	40 ug	Intravenous
Subject	Fentanyl	Other / unclassified	50 ug	Intravenous
Subject	Fentanyl	Other / unclassified	54 ug	Intravenous
Subject	Fentanyl	Other / unclassified	80 ug	Intravenous
Background	Naltrexone	Small molecule	50 mg	Oral

Indications

No indication recorded.