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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01309425 | A Study to Compare the Dose-proportionality of Tapentadol (CG5503) in Healthy Japanese and Korean Male Volunteers | PHASE1 | COMPLETED | 52 | — | — | Feb 1, 2011 | May 1, 2011 | Jan 31, 2014 | - | — |
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | tapentadol (CG5503) ER 25-mg TRF 25mg TRF single oral dose |
| 002 | EXPERIMENTAL | tapentadol (CG5503) ER 50-mg TRF 50mg TRF single oral dose |
| 003 | EXPERIMENTAL | tapentadol (CG5503) ER 100-mg TRF 100mg TRF single oral dose |
| 004 | EXPERIMENTAL | tapentadol (CG5503) ER two 100-mg TRF 200mg TRF single oral dose |
| Name | Type | Description |
|---|---|---|
| tapentadol (CG5503) ER two 100-mg TRF | DRUG | 200mg TRF single oral dose |
| tapentadol (CG5503) ER 50-mg TRF | DRUG | 50mg TRF single oral dose |
| tapentadol (CG5503) ER 25-mg TRF | DRUG | 25mg TRF single oral dose |
| tapentadol (CG5503) ER 100-mg TRF | DRUG | 100mg TRF single oral dose |
Inclusion Criteria: * Healthy Japanese and Korean male volunteers, inclusive * Body mass index (BMI) between 18.5 and 25 kg/m², inclusive, and a body weight of not less than 50 kg * Japanese volunteers must have resided outside of Japan for no more than 5 years, and their parents and maternal and p...