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 investigational small molecule being studied in healthy participants. It is a new extended-release 250-mg tablet formulation of tapentadol, intended to assess bioequivalence with an existing tapentadol extended-release 250-mg tablet. It is currently in Phase 1 clinical development.
Tapentadol 250-mg TRF is being developed by Johnson & Johnson (NYSE: JNJ). The company is conducting clinical trials to evaluate this new extended-release 250-mg tablet formulation of tapentadol in healthy participants.
Tapentadol 250-mg TRF is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug remains under clinical investigation.
Tapentadol 250-mg TRF has one completed clinical trial, NCT01981278, which assessed bioequivalence of the new extended-release 250-mg tablet with respect to a tapentadol extended-release 250-mg tablet in healthy participants. The trial enrolled 63 participants in the United States and was a controlled, randomized study.
Tapentadol 250-mg TRF is a new extended-release 250-mg tablet formulation of tapentadol. It is being studied to assess bioequivalence with respect to a tapentadol extended-release 250-mg tablet, meaning the trial compares the two formulations to determine if they are equivalent in how they are absorbed and processed by the body.