Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
tapentadol 100-mg TRF · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | tapentadol (CG5503) ER 50-mg TRF 100 mg TRF single oral dose |
| 002 | EXPERIMENTAL | tapentadol (CG5503) ER 100-mg TRF 100mg TRF single oral dose |
| Name | Type | Description |
|---|---|---|
| tapentadol (CG5503) ER 100-mg TRF | DRUG | 100mg TRF single oral dose |
| tapentadol (CG5503) ER 50-mg TRF | DRUG | 100 mg TRF single oral dose |
Inclusion Criteria: * Japanese participants who have resided outside of Japan for no more than 5 years and whose parents and maternal and paternal grandparents are Japanese, as determined by participant's verbal report * Deemed healthy on the basis of prestudy physical examination, medical history ...
Tapentadol 100-mg TRF is an investigational small molecule being developed by Johnson & Johnson (JNJ). It is a 100-mg tablet formulation of tapentadol, studied in healthy volunteers. The drug is in Phase 1 clinical development and is not yet approved by regulatory authorities.
Tapentadol 100-mg TRF is being studied for use in healthy volunteers, specifically to assess the bioequivalence of a 50-mg dose administered as two 50-mg tablets relative to one 100-mg tablet. The indication listed is Healthy Volunteer, and it is not intended for a specific disease condition.
Johnson & Johnson (JNJ) is developing tapentadol 100-mg TRF. The company is conducting clinical trials for this investigational drug, which is currently in Phase 1 development.
Tapentadol 100-mg TRF is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, and the drug is not yet available for clinical use.
Tapentadol 100-mg TRF is associated with one completed Phase 1 clinical trial, NCT01273532. This study compared the bioequivalence of a 50-mg dose administered as two 50-mg tablets relative to one 100-mg tablet in 30 healthy male volunteers.
Tapentadol 100-mg TRF is a specific tablet formulation of tapentadol, a small molecule drug. The trial NCT01273532 evaluates the bioequivalence of different tablet strengths, indicating that the 100-mg TRF is a dosage form of tapentadol.