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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01900587 | A Pivotal Study to Evaluate the Bio-equivalence of the Tapentadol Extended-Release (ER) Tamper-resistant Formulation (TRF) Tablet to the Current Tapentadol ER Prolonged-release 2 (PR2) Tablet | PHASE1 | COMPLETED | 64 | — | — | Jul 1, 2010 | Aug 1, 2010 | Nov 1, 2013 | 1 | United States |
The C(max) is the maximum serum concentration which will be observed at the defined time points.
The AUC (infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
The AUC (last) is the area under the serum concentration-time curve from time zero time of the last quantifiable concentration C(last), and C(last) is the last observed quantifiable concentration.
| Arm | Type | Description |
|---|---|---|
| Tapentadol Extended release (ER) TRF then tapentadol ER PR2 | EXPERIMENTAL | Single dose of tapentadol ER 50 milligram (mg), tamper-resistant formulation (TRF) tablet will be administered under fasted condition in first treatment period; after that in second treatment period, single-dose of tapentadol ER 50 mg, prolonged released (PR2) tablet will be administered under fasted condition. A washout period of 7 to 14 days will be maintained between each treatment period. |
| Tapentadol ER PR2 then tapentadol ER TRF | EXPERIMENTAL | Single dose of tapentadol ER 50 milligram (mg), PR2 tablet will be administered under fasted condition in first treatment period; after that in second treatment period, single-dose of tapentadol ER 50 mg, TRF tablet will be administered under fasted condition. A washout period of 7 to 14 days will be maintained between each treatment period. |
| Name | Type | Description |
|---|---|---|
| Tapentadol ER Tamper-resistant Formulation (TRF) | DRUG | Single dose of tapentadol ER 50 milligram (mg), will be administered under fasted condition. |
| Tapentadol ER Prolonged-Release 2 (PR2) | DRUG | Single dose of tapentadol ER 50 milligram (mg), prolonged release tablet will be administered under fasted condition. |
Inclusion Criteria: * Participants deemed healthy on the basis of pre-study physical examination, medical history (including smoking habits), 12-lead electrocardiogram (ECG), vital signs, and clinical laboratory parameters (serum chemistry, serology and hematology) performed within 21 days before s...