Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tapentadol Tamper-resistant Formulation · 1 trial · 1 indication
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...
Tapentadol Tamper-resistant Formulation is an investigational small molecule being studied in healthy volunteers. It is a tamper-resistant extended-release formulation of tapentadol, intended to deter abuse. The drug is in Phase 1 clinical development and is not yet approved.
Johnson & Johnson (NYSE: JNJ) is developing Tapentadol Tamper-resistant Formulation. The company is conducting clinical trials to evaluate the drug's bioequivalence to the current tapentadol extended-release tablet.
Tapentadol Tamper-resistant Formulation is in Phase 1 clinical development. One Phase 1 study has been completed, and the drug remains investigational. It has not been approved by regulatory authorities.
Tapentadol Tamper-resistant Formulation has one completed clinical trial, NCT01900587, a pivotal study evaluating bioequivalence of the tamper-resistant extended-release tablet to the current tapentadol ER prolonged-release 2 tablet. The study enrolled 64 healthy volunteers in the United States.
Tapentadol Tamper-resistant Formulation is a new extended-release formulation of tapentadol designed to be tamper-resistant. It is being compared to the current tapentadol ER prolonged-release 2 tablet in clinical trials to assess bioequivalence.