Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tapentadol 250-mg TRF · 1 trial · 1 indication
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-...
Tapentadol 250-mg TRF is an extended-release tablet formulation of tapentadol developed by Johnson & Johnson. It is a small molecule that acts on SLC6A2 and OPRM1. The specific indication for this formulation has not been disclosed. It is currently in Phase 1 clinical development.
Tapentadol 250-mg TRF targets SLC6A2 and OPRM1. It is classified as an inhibitor of these targets. SLC6A2 is the norepinephrine transporter, and OPRM1 is the mu-opioid receptor. This dual mechanism is characteristic of tapentadol.
Tapentadol 250-mg TRF is being developed by Johnson & Johnson, which trades under the ticker symbol JNJ. Johnson & Johnson is the sponsor of the clinical trial for this formulation.
Tapentadol 250-mg TRF is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trial for this formulation has been completed.
Tapentadol 250-mg TRF has been studied in one clinical trial: NCT01981278. This Phase 1 trial was a bioequivalence study comparing a new extended-release 250-mg tablet to an existing extended-release 250-mg tablet in 63 healthy participants. The trial was completed.