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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01981278 | A Study to Assess Bioequivalence of a New Tapentadol Extended-Release 250-mg Tablet With Respect to a Tapentadol Extended-Release 250-mg Tablet in Healthy Participants | PHASE1 | COMPLETED | 63 | — | — | Jul 1, 2010 | Aug 1, 2010 | Nov 14, 2013 | 1 | United States |
Cmax is defined as maximum observed analyte concentration.
AUClast is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | Tapentadol ER 250-mg tamper-resistant formulation (TRF) tablet will be administered as a single oral dose under fasted condition. |
| Treatment B | EXPERIMENTAL | Tapentadol ER 250-mg prolonged-release formulation 2 (PR2) tablet will be administered as a single oral dose under fasted condition. |
| Name | Type | Description |
|---|---|---|
| Tapentadol ER 250-mg TRF tablet | DRUG | Participants will receive single oral dose of tapentadol ER 250-mg TRF tablet on Day 1 of each treatment period. |
| Tapentadol ER 250-mg PR2 tablet | DRUG | Participants will receive single oral dose of tapentadol PR2 250-mg tablet on Day 1 of each treatment period. |
Inclusion Criteria: * Signed an informed consent document indicating they understand the purpose of and procedures required for the study, are willing to participate in the study, and are willing to adhere to the prohibitions and restrictions specified in the protocol * Healthy on the basis of pre-...