Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01273506 | A Study to Compare the Bioequivalence of 50-mg Tapentadol (CG5503) Dose Administered as Two 25-mg Tablets Relative to One 50-mg Tablet | PHASE1 | COMPLETED | 30 | — | — | Dec 1, 2010 | Feb 1, 2011 | Mar 13, 2012 | - | — |
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | tapentadol (CG5503) ER 25-mg TRF 50 mg TRF single oral dose |
| 002 | EXPERIMENTAL | tapentadol (CG5503) ER 50-mg TRF 50 mg TRF single oral dose |
| Name | Type | Description |
|---|---|---|
| tapentadol (CG5503) ER 25-mg TRF | DRUG | 50 mg TRF single oral dose |
| tapentadol (CG5503) ER 50-mg TRF | DRUG | 50 mg TRF single oral dose |
Inclusion Criteria: * Japanese participants who have resided outside of Japan for no more than 5 years and whose parents and maternal and paternal grandparents are Japanese, as determined by participant's verbal report * Deemed healthy on the basis of prestudy physical examination, medical history ...