A Study to Assess the Relative Bioavailability of 4 Formulations of Fentanyl Transdermal System Compared Against DUROGESIC Fentanyl Transdermal Patch After Single Application in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

November 30, 2012

Study Completion Date

November 30, 2012

Conditions
Healthy
Interventions
DRUG

Treatment A: DUROGESIC (8.4 mg fentanyl)

One DUROGESIC transdermal patch containing 8.4 mg of fentanyl applied on the skin for 72 hours.

DRUG

Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl)

One transdermal system-concept 1 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.

DRUG

Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl)

One transdermal system-concept 2 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.

DRUG

Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl)

One transdermal system-concept 3 patch containing approximately 7.1 mg of fentanyl applied on the skin for 72 hours.

DRUG

Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)

One transdermal system-concept 4 patch containing approximately 11.0 mg of fentanyl applied on the skin for 72 hours.

Trial Locations (1)

Unknown

Antwerp

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT01717157 - A Study to Assess the Relative Bioavailability of 4 Formulations of Fentanyl Transdermal System Compared Against DUROGESIC Fentanyl Transdermal Patch After Single Application in Healthy Volunteers | Biotech Hunter | Biotech Hunter