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
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the cumulative adhesion percentage for the test
      products and the reference products for both small and large patches.
    

Detailed description: 
      This is a randomized (study medication assigned to participants by chance), single-center,
      parallel-group single-application, modified 3-way crossover study. Each participant will
      receive the marketed reference formulation (DURAGESIC) or the JNJ-35685-AAA-G016 or
      JNJ-35685-AAA-G021 fentanyl transdermal system (TDS). The study consists of a screening phase
      within 21 and 2 days before the first TDS application of the first period; a
      partially-blinded treatment phase consisting of 3 single-application treatment periods; and
      end-of-study or withdrawal assessments done upon completion of the 72-hour adhesion
      assessment on Day 5 of Period 3 or upon withdrawal. A 7- to 16-day washout period will
      separate the treatment periods, commencing at transdermal patch removal. The duration of
      participation in the study for an individual participant will be 31 days to a maximum of 68
      days (including screening and follow-up visits). Participants will be primarily evaluated for
      cumulative adhesion percentage. Participants' safety will be monitored throughout the study.
    

Intervention name(s): Duragesic (Fentanyl Transdermal System [TDS] Small Patches); New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches); Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches); Duragesic (Fentanyl TDS Large Patches); New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches); Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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 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 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 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 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 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.
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Other
Keywords: Healthy; JNJ-35685-AAA-G016; JNJ-35685-AAA-G021; DURAGESIC; Fentanyl