Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tapentadol Tamper-Resistant Formulation · 2 trials · 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. |
| Treatment Sequence AB | EXPERIMENTAL | Participants will receive single dose of new tapentadol Extended Release (ER) Tamper-Resistant Formulation (TRF) tablet and later, participants will receive single dose of current tapentadol prolonged-release formulation 2 (PR2) tablet without food. Administration of the study medications will be separated by a washout period (no treatment) of 7 to 14 days. |
| Treatment Sequence BA | EXPERIMENTAL | Participants will receive single dose of current tapentadol PR2 tablet and later, participants will receive single dose of new tapentadol ER TRF tablet without food. Administration of the study medication will be separated by a washout period of 7 to 14 days. |
| 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. |
| Tapentadol Extended Release (ER) Tamper-Resistant Formulation (TRF) | DRUG | Participants will receive a single dose of tapentadol ER TRF 100 mg tablet orally (by mouth) in treatment sequences AB and BA appropriately. |
| Tapentadol Prolonged-Release Formulation 2 (PR2) | DRUG | Participants will receive a single dose of tapentadol PR2 100 mg tablet orally in treatment sequences AB and BA appropriately. |
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 extended-release oral tablet of tapentadol designed to resist tampering, such as crushing or chewing, that can release the full dose at once. It is a small molecule developed by Johnson & Johnson (ticker JNJ) and is in Phase 1 clinical development.
Tapentadol Tamper-Resistant Formulation targets SLC6A2, the norepinephrine transporter, and OPRM1, the mu-opioid receptor. It acts as an inhibitor at both targets, combining norepinephrine reuptake inhibition with mu-opioid receptor agonism in a single small molecule.
Johnson & Johnson, which trades under the ticker JNJ, is the developer of Tapentadol Tamper-Resistant Formulation. The company is also known as the sponsor of the clinical study conducted for this extended-release, tamper-resistant tablet.
Tapentadol Tamper-Resistant Formulation is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed, and no trials are currently active.
Tapentadol Tamper-Resistant Formulation has been studied in one completed Phase 1 trial, NCT02019485. That randomized, controlled bioequivalence study enrolled 64 healthy volunteers in the United States and compared a new tapentadol extended-release tablet with an existing tapentadol extended-release tablet under fasted conditions.