Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tapentadol Prolonged-Release Formulation 2 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Treatment Sequence AB | EXPERIMENTAL | Participants will receive single dose of new tapentadol Extended Release (ER) Tamper-Resistant Formulation (TRF) tablet and later, participants will receive single dose of current tapentadol prolonged-release formulation 2 (PR2) tablet without food. Administration of the study medications will be separated by a washout period (no treatment) of 7 to 14 days. |
| Treatment Sequence BA | EXPERIMENTAL | Participants will receive single dose of current tapentadol PR2 tablet and later, participants will receive single dose of new tapentadol ER TRF tablet without food. Administration of the study medication will be separated by a washout period of 7 to 14 days. |
| Name | Type | Description |
|---|---|---|
| Tapentadol Extended Release (ER) Tamper-Resistant Formulation (TRF) | DRUG | Participants will receive a single dose of tapentadol ER TRF 100 mg tablet orally (by mouth) in treatment sequences AB and BA appropriately. |
| Tapentadol Prolonged-Release Formulation 2 (PR2) | DRUG | Participants will receive a single dose of tapentadol PR2 100 mg tablet orally in treatment sequences AB and BA appropriately. |
Inclusion Criteria: * Agrees to protocol-defined use of effective contraception * Body mass index (BMI) between 20 and 28 kilograms per square meter, inclusive, and body weight not less than 50 kg (BMI is calculated as weight \[kilogram\] divided by square of height \[meter\]) * Habitually smokes n...
Tapentadol Prolonged-Release Formulation 2 is an investigational small molecule being studied in healthy volunteers. It is a prolonged-release formulation of tapentadol, an analgesic. The drug is currently in Phase 1 clinical development and is not approved for any indication.
Tapentadol Prolonged-Release Formulation 2 is being developed by Johnson & Johnson (NYSE: JNJ). The company is conducting clinical trials to assess the drug's bioequivalence in healthy subjects.
Tapentadol Prolonged-Release Formulation 2 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.
Tapentadol Prolonged-Release Formulation 2 has one completed clinical trial, NCT02019485. This was a Phase 1 study assessing bioequivalence of a new extended-release tablet compared to a reference tablet under fasted conditions in 64 healthy subjects in the United States.
Tapentadol Prolonged-Release Formulation 2 is a prolonged-release formulation of tapentadol. The clinical trial NCT02019485 compared a new tapentadol extended-release tablet to a reference tapentadol extended-release tablet, indicating the drug is a formulation variant of tapentadol.