Ignite Creation Date:
2024-05-06 @ 7:49 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02608320
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2015-11-17
Brief Title:
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
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Randomized Partially-blinded Two-arm Single-application 3-way Crossover 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 Subjects
Status:
COMPLETED
Status Verified Date:
2017-06
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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FENPAI1025 | OTHER | Janssen Research Development LLC | None |