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tapentadol two 100-mg TRF · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | tapentadol (CG5503) ER 25-mg TRF 25mg TRF single oral dose |
| 002 | EXPERIMENTAL | tapentadol (CG5503) ER 50-mg TRF 50mg TRF single oral dose |
| 003 | EXPERIMENTAL | tapentadol (CG5503) ER 100-mg TRF 100mg TRF single oral dose |
| 004 | EXPERIMENTAL | tapentadol (CG5503) ER two 100-mg TRF 200mg TRF single oral dose |
| Name | Type | Description |
|---|---|---|
| tapentadol (CG5503) ER two 100-mg TRF | DRUG | 200mg TRF single oral dose |
| tapentadol (CG5503) ER 50-mg TRF | DRUG | 50mg TRF single oral dose |
| tapentadol (CG5503) ER 25-mg TRF | DRUG | 25mg TRF single oral dose |
| tapentadol (CG5503) ER 100-mg TRF | DRUG | 100mg TRF single oral dose |
Inclusion Criteria: * Healthy Japanese and Korean male volunteers, inclusive * Body mass index (BMI) between 18.5 and 25 kg/m², inclusive, and a body weight of not less than 50 kg * Japanese volunteers must have resided outside of Japan for no more than 5 years, and their parents and maternal and p...
Tapentadol two 100-mg TRF is an investigational extended-release formulation of tapentadol studied as two 100-mg tablets taken together. It was evaluated in a Phase 1 dose-proportionality study in healthy Japanese and Korean male volunteers. The clinical indication for this formulation has not been disclosed.
Tapentadol two 100-mg TRF targets SLC6A2, the norepinephrine transporter, and OPRM1, the mu-opioid receptor. It acts as an inhibitor at these targets, combining norepinephrine reuptake inhibition with mu-opioid receptor agonism in a single small-molecule agent.
Johnson & Johnson, ticker JNJ, is the developer of tapentadol two 100-mg TRF. The compound is also referenced by the code CG5503.
Tapentadol two 100-mg TRF is in Phase 1 development. It is investigational and has not been approved by the FDA. The single Phase 1 trial of this formulation has been completed.
Tapentadol two 100-mg TRF was studied in one completed Phase 1 trial, NCT01309425, titled A Study to Compare the Dose-proportionality of Tapentadol (CG5503) in Healthy Japanese and Korean Male Volunteers. The randomized, controlled trial enrolled 52 healthy male volunteers aged 20 years and older.