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 immediate-release tablet formulation of tapentadol studied at a 100-mg dose. It was evaluated in a Phase 1 bioequivalence study comparing two 50-mg tablets against one 100-mg tablet. The formulation is also known as tapentadol (CG5503) ER 100-mg TRF.
Tapentadol 100-mg TRF 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.
Tapentadol 100-mg TRF is developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored the Phase 1 bioequivalence study of the 100-mg tablet formulation.
Tapentadol 100-mg TRF is in Phase 1 development. It is investigational and has not been approved by the FDA for any indication. One Phase 1 trial has been completed, and no trials are currently active.
Tapentadol 100-mg TRF was studied in NCT01273532, a completed Phase 1 trial titled A Study to Compare the Bioequivalence of 50-mg Tapentadol (CG5503) Dose Administered as Two 50-mg Tablets Relative to One 100-mg Tablet. The trial enrolled 30 healthy male volunteers aged 20 years and older.