Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-31 @ 10:21 PM
Study NCT ID:
NCT01273532
Status:
COMPLETED
Last Update Posted:
2012-03-13
First Post:
2011-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare the Bioequivalence of 50-mg Tapentadol (CG5503) Dose Administered as Two 50-mg Tablets Relative to One 100-mg Tablet
Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Organization:
Study Overview
Official Title:
A Single-Dose, Open-Label, Randomized, Two-Way Crossover Study to Assess the Bioequivalence of Tapentadol Given as Two 50-mg Extended-Release, Tamper-Resistant Formulation (TRF) Tablets Relative to One 100-mg Extended-Release TRF Tablet in Healthy Japanese Male Subjects
Status:
COMPLETED
Status Verified Date:
2012-03
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 a 100-mg tapentadol (CG5503) dose administered as two 50-mg ER, TRF tablets relative to one 100-mg ER TRF tablet in healthy Japanese male participants.
Detailed Description:
This is an open-label (all people know the identity of the intervention), single-center, randomized (the study drug is assigned by chance), 2-way crossover study (participants may receive different interventions sequentially during the trial). All participants will receive a single 100-mg dose of tapentadol (CG5503) during 2 periods, in randomized order, as two 50-mg TRF tablets and one 100-mg TRF tablet. All participants will be randomly assigned to 1 of 2 possible treatment sequences and receive both of the following treatments, 1 in each period:
Treatment A: two tapentadol (CG5503) ER 50-mg TRF tablets, administered as a single oral dose under fasted condition Treatment B: one tapentadol (CG5503) ER 100-mg TRF tablet, administered as a single oral dose under fasted condition Each period will be separated by 7 - 14 days
Treatment A: two tapentadol (CG5503) ER 50-mg TRF tablets, administered as a single oral dose under fasted condition Treatment B: one tapentadol (CG5503) ER 100-mg TRF tablet, administered as a single oral dose under fasted condition Each period will be separated by 7 - 14 days
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
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 |
|---|---|---|---|---|
| R331333PAI1063 | None | None | View |