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

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

May 31, 2007

Study Completion Date

May 31, 2007

Conditions
Pain
Interventions
DRUG

Fentanyl 400 µg sublingual spray

DRUG

Actiq® 400 µg transmucosally

Actiq® 400 µg is a solid formulation of fentanyl citrate on a plastic stick that dissolves slowly in the mouth for absorption across the buccal mucosa.

DRUG

Fentanyl citrate injection 100 µg intravenously

DRUG

Naltrexone 50 mg

Naltrexone hydrochloride was administered approximately 12 hours and 1 hour prior to and 12 hours after each dose of fentanyl to minimize the occurrence of unacceptable adverse effects (eg, decreased respiration, nausea) often associated with administration of fentanyl.

Trial Locations (1)

78759

CEDRA Clinical Research, LLC, Austin

Sponsors
All Listed Sponsors
lead

INSYS Therapeutics Inc

INDUSTRY

NCT01780233 - Pharmacokinetic Study of Fentanyl 400 µg Sublingual Spray, Actiq® 400 µg Transmucosally, and Fentanyl Citrate Injection 100 µg Intravenously (iv) | Biotech Hunter | Biotech Hunter