Ignite Creation Date:
2024-05-06 @ 7:52 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02617758
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2015-11-17
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:
Janssen Research Development LLC
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:
2018-03
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 mcgh dose of DURAGESIC fentanyl transdermal system as Treatment A Reference and 100 mcgh 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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FENPAI1023 | OTHER | Janssen Research Development LLC | None |