Trials / Completed
CompletedNCT01273506
A Study to Compare the Bioequivalence of 50-mg Tapentadol (CG5503) Dose Administered as Two 25-mg Tablets Relative to One 50-mg Tablet
A Single-Dose, Open-Label, Randomized, Two-Way Crossover Study to Assess the Bioequivalence of Tapentadol Given as Two 25-mg Extended-Release Tamper-Resistant Formulation (TRF) Tablets Relative to One 50-mg Extended-Release TRF Tablet in Healthy Japanese Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
- Sex
- Male
- Age
- 20 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the bioequivalence of a 50-mg tapentadol (CG5503) dose administered as two 25-mg ER, TRF tablets relative to one 50-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 50-mg dose of tapentadol (CG5503) during 2 periods, in randomized order, as two 25-mg TRF tablets and one 50-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 25-mg TRF tablets, administered as a single oral dose under fasted condition Treatment B: one tapentadol (CG5503) ER 50-mg TRF tablet, administered as a single oral dose under fasted condition Each period will be separated by 7 - 14 days
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tapentadol (CG5503) ER 25-mg TRF | 50 mg TRF single oral dose |
| DRUG | tapentadol (CG5503) ER 50-mg TRF | 50 mg TRF single oral dose |
Timeline
- Start date
- 2010-12-01
- Completion
- 2011-02-01
- First posted
- 2011-01-10
- Last updated
- 2012-03-13
Source: ClinicalTrials.gov record NCT01273506. Inclusion in this directory is not an endorsement.