Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-02-20 @ 6:20 PM
Study NCT ID:
NCT02617758
Status:
COMPLETED
Last Update Posted:
2025-02-03
First Post:
2015-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Fentanyl Transdermal System (JNJ-35685-AAA-G021) Compared With DURAGESIC Fentanyl Transdermal Patch in Healthy Participants
Sponsor:
Janssen Research & Development, LLC
Organization:
Study Overview
Official Title:
An Open-Label, Randomized, Single Application, Two-Period Crossover, Pivotal Bioequivalence Study to Evaluate the Bioequivalence of Fentanyl Transdermal System (JNJ-35685-AAA-G021) Compared With DURAGESIC Fentanyl Transdermal Patch in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the bioequivalence of the new formulation of fentanyl transdermal system (JNJ-35685-AAA-G021) compared with DURAGESIC fentanyl in healthy participants.
Detailed Description:
This is a single-center, randomized (study medication assigned to participants by chance), open-label (all people know the identity of the intervention), single application and 2-way Crossover (the same medications provided to all participants but in different sequence) pivotal study to determine the bioequivalence of marketed reference formulation DURAGESIC and the test formulation Fentanyl transdermal system (JNJ-35685-AAA-G021). Approximately 56 healthy participants will participate in this study. Participants will be randomly assigned to 1 of 2 treatment sequences. The study will consist of 3 parts: Screening Phase (within 21 days before the first study drug administration of the first period), an open-label treatment Phase consisting of 2 single-application treatment periods (26 days) and End-of-Study (at the end of Period 2). The total study duration for each participant will be from 43 days to a maximum of 59 days. Participants will receive a single application 100 microgram per hour (mcg/h) dose of DURAGESIC fentanyl transdermal system as Treatment A (Reference) and 100 mcg/h Fentanyl transdermal system (JNJ-35685-AAA-G021) as Treatment B (Test). Bioequivalence will be primarily evaluated by pharmacokinetic parameters. Participants' safety will be monitored throughout the study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| FENPAI1023 | OTHER | Janssen Research & Development, LLC | View |