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
NCT ID: NCT02608320
Last Updated: 2025-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
52 participants
INTERVENTIONAL
2015-11-17
2016-04-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
Study Groups
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Treatment Sequence (ACB) Position (RLR)
Participants will receive treatment A (Duragesic 12.5 microgram per hour \[mcg/h\]) applied to right paraspinal side in period 1, then treatment C (aged JNJ- 35685-AAA-G016 12.5 mcg/h) applied to left paraspinal side in period 2 and then treatment B (New JNJ-35685- AAA-G016 12.5 mcg/h) applied to right paraspinal side in period 3.
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.
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.
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.
Treatment Sequence (BAC) Position (RLR)
Participants will receive treatment B applied to right paraspinal side in period 1, then treatment A applied to left paraspinal side in period 2 and then treatment C applied to right paraspinal side in period 3.
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.
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.
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.
Treatment Sequence (CBA) Position (RLR)
Participants will receive treatment C applied to right paraspinal side in period 1, then treatment B applied to left paraspinal side in period 2 and then treatment A applied to right paraspinal side in period 3.
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.
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.
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.
Treatment Sequence (BCA) Position (RLR)
Participants will receive treatment B applied to right paraspinal side in period 1, then treatment C applied to left paraspinal side in period 2 and then treatment A applied to right paraspinal side in period 3.
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.
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.
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.
Treatment Sequence (CAB) Position (RLR)
Participants will receive treatment C applied to right paraspinal side in period 1, then treatment A applied to left paraspinal side in period 2 and then treatment B applied to right paraspinal side in period 3.
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.
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.
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.
Treatment Sequence (ABC) Position (RLR)
Participants will receive treatment A applied to right paraspinal side in period 1, then treatment B applied to left paraspinal side in period 2 and then treatment C applied to right paraspinal side in period 3.
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.
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.
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.
Treatment Sequence (ACB) Position (LRL)
Participants will receive treatment A applied to left paraspinal side in period 1, then treatment C applied to right paraspinal side in period 2 and then treatment B applied to left paraspinal side in period 3.
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.
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.
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.
Treatment Sequence (BAC) Position (LRL)
Participants will receive treatment B applied to left paraspinal side in period 1, then treatment A applied to right paraspinal side in period 2 and then treatment C applied to left paraspinal side in period 3.
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.
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.
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.
Treatment Sequence (CBA) Position (LRL)
Participants will receive treatment C applied to left paraspinal side in period 1, then treatment B applied to right paraspinal side in period 2 and then treatment A applied to left paraspinal side in period 3.
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.
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.
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.
Treatment Sequence (BCA) Position (LRL)
Participants will receive treatment B applied to left paraspinal side in period 1, then treatment C applied to right paraspinal side in period 2 and then treatment A applied to left paraspinal side in period 3.
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.
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.
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.
Treatment Sequence (CAB) Position (LRL)
Participants will receive treatment C applied to left paraspinal side in period 1, then treatment A applied to right paraspinal side in period 2 and then treatment B applied to left paraspinal side in period 3.
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.
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.
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.
Treatment Sequence (ABC) Position (LRL)
Participants will receive treatment A applied to left paraspinal side in period 1, then treatment B applied to right paraspinal side in period 2 and then treatment C applied to left paraspinal side in period 3.
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.
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.
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.
Treatment Sequence (DFE) Position (RLR)
Participants will receive treatment D (Duragesic 100 mcg/h) applied to right paraspinal side in period 1, then treatment F (aged JNJ-35685-AAA-G021 100 mcg/h) applied to left paraspinal side in period 2 and then treatment E (new JNJ-35685-AAA-G021 100 mcg/h) applied to right paraspinal side in period 3.
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.
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.
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.
Treatment Sequence (EDF) Position (RLR)
Participants will receive treatment E applied to right paraspinal side in period 1, then treatment D applied to left paraspinal side in period 2 and then treatment F applied to right paraspinal side in period 3.
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.
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.
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.
Treatment Sequence (FED) Position (RLR)
Participants will receive treatment F applied to right paraspinal side in period 1, then treatment E applied to left paraspinal side in period 2 and then treatment D applied to right paraspinal side in period 3.
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.
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.
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.
Treatment Sequence (EFD) Position (RLR)
Participants will receive treatment E applied to right paraspinal side in period 1, then treatment F applied to left paraspinal side in period 2 and then treatment D applied to right paraspinal side in period 3.
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.
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.
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.
Treatment Sequence (FDE) Position (RLR)
Participants will receive treatment F applied to right paraspinal side in period 1, then treatment D applied to left paraspinal side in period 2 and then treatment E applied to right paraspinal side in period 3.
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.
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.
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.
Treatment Sequence (DEF) Position (RLR)
Participants will receive treatment D applied to right paraspinal side in period 1, then treatment E applied to left paraspinal side in period 2 and then treatment F applied to right paraspinal side in period 3.
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.
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.
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.
Treatment Sequence (DFE) Position (LRL)
Participants will receive treatment D applied to left paraspinal side in period 1, then treatment F applied to right paraspinal side in period 2 and then treatment E applied to left paraspinal side in period 3.
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.
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.
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.
Treatment Sequence (EDF) Position (LRL)
Participants will receive treatment E applied to left paraspinal side in period 1, then treatment D applied to right paraspinal side in period 2 and then treatment F applied to left paraspinal side in period 3.
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.
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.
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.
Treatment Sequence (FED) Position (LRL)
Participants will receive treatment F applied to left paraspinal side in period 1, then treatment E applied to right paraspinal side in period 2 and then treatment D applied to left paraspinal side in period 3.
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.
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.
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.
Treatment Sequence (EFD) Position (LRL)
Participants will receive treatment E applied to left paraspinal side in period 1, then treatment F applied to right paraspinal side in period 2 and then treatment D applied to left paraspinal side in period 3.
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.
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.
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.
Treatment Sequence (FDE) Position (LRL)
Participants will receive treatment F applied to left paraspinal side in period 1, then treatment D applied to right paraspinal side in period 2 and then treatment E applied to left paraspinal side in period 3.
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.
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.
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.
Treatment Sequence (DEF) Position (LRL)
Participants will receive treatment D applied to left paraspinal side in period 1, then treatment E applied to right paraspinal side in period 2 and then treatment F applied to left paraspinal side in period 3.
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.
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.
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.
Interventions
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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.
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.
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \[beta-hCG\]) test at screening and urine pregnancy test at Day -1 of the first treatment period
* A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control example, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after completion of the study
* Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
* Body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m\^2), inclusive, and a body weight of not less than 50 kg
Exclusion Criteria
* Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening as deemed appropriate by the investigator
* Clinically significant abnormal physical examination, vital signs or 12 lead ECG at screening as deemed appropriate by the investigator
* Use of medications or treatments that would significantly influence or exaggerate patch adhesion or that would alter inflammatory or immune response to the study product (example antihistamines, systemic or topical corticosteroids, cyclosporine, tacrolimus, cytotoxic drugs, immune globulin, Bacillus Calmette-Guerin (BCG), monoclonal antibodies, radiation therapy)
* History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines, and benzodiazepines) at screening. Participants must not use tobacco products, including all nicotine use, example, cigarettes, cigars, chewing tobacco, patch, gum
18 Years
65 Years
ALL
Yes
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Cypress, California, United States
Countries
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Other Identifiers
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FENPAI1025
Identifier Type: OTHER
Identifier Source: secondary_id
CR108060
Identifier Type: -
Identifier Source: org_study_id
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