40
Participants
Start Date
April 30, 2007
Primary Completion Date
May 31, 2007
Study Completion Date
May 31, 2007
Fentanyl 400 µg sublingual spray
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.
Fentanyl citrate injection 100 µg intravenously
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.
CEDRA Clinical Research, LLC, Austin
Lead Sponsor
INSYS Therapeutics Inc
INDUSTRY