A Study to Evaluate the Adherence of 2 Strengths of Newly Manufactured Samples and Aged Samples of a New Formulation (JNJ-35685-AAA-G016 and JNJ-35685-AAA-G021) of Fentanyl Transdermal System Compared With Duragesic Fentanyl Transdermal Patch in Healthy Participants

PHASE1CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

November 17, 2015

Primary Completion Date

April 13, 2016

Study Completion Date

April 13, 2016

Conditions
Healthy
Interventions
DRUG

Duragesic (Fentanyl Transdermal System [TDS] Small Patches)

Duragesic 12.5 mcg/h (Treatment A) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.

DRUG

New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches)

New JNJ-35685-AAA-G016 12.5 mcg/h (Treatment B) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.

DRUG

Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)

Aged JNJ-35685-AAA-G016 12.5 mcg/h (Treatment C) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.

DRUG

Duragesic (Fentanyl TDS Large Patches)

Duragesic 100 mcg/h (Treatment D) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours, applied to the paraspinal region of the back for 72 hours.

DRUG

New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)

New JNJ-35685-AAA-G021 100 mcg/h (Treatment E) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.

DRUG

Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)

Aged JNJ-35685-AAA-G021 100 mcg/h (Treatment F) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.

Trial Locations (1)

Unknown

Cypress

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02608320 - A Study to Evaluate the Adherence of 2 Strengths of Newly Manufactured Samples and Aged Samples of a New Formulation (JNJ-35685-AAA-G016 and JNJ-35685-AAA-G021) of Fentanyl Transdermal System Compared With Duragesic Fentanyl Transdermal Patch in Healthy Participants | Biotech Hunter | Biotech Hunter