Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rivaroxaban once daily · 1 trial · 1 indication
Pharamacodymic (PD) variables (ie, PT, INR, aPTT, TGA, and anti-FXa) are blood coagulation (or clotting) tests. These blood clotting tests will be performed to assess the effects of Prothrombin Complex Concentrates (PCCs) (Profilnine SD or Beriplex P/N) on the pharmacodynamics of rivaroxaban.
| Arm | Type | Description |
|---|---|---|
| Rivaroxaban + Profilnine SD | EXPERIMENTAL | Rivaroxaban 20 mg twice a day on Days 1-4 followed by rivaroxaban 20 mg once a day on Day 5 administered 4 hours before a single bolus dose of Profilnine SD 50 IU/kg. |
| Rivaroxaban + Beriplex P/N | EXPERIMENTAL | Rivaroxaban 20 mg twice a day on Days 1-4 followed by rivaroxaban 20 mg once a day on Day 5 administered 4 hours before a single bolus dose of Beriplex 50 IU/kg. |
| Rivaroxaban + Saline | EXPERIMENTAL | Rivaroxaban 20 mg twice a day on Days 1-4 followed by rivaroxaban 20 mg once a day on Day 5 administered 4 hours before a single 100cc bolus of saline. |
| Name | Type | Description |
|---|---|---|
| Rivaroxaban 20 mg twice daily | DRUG | One rivaroxaban 20 mg tablet administered twice a day (b.i.d.) for 4 days (Days 1-4). Interpretation by CTRL: Concentration type = Exact; Number = 20; unit=mg; route: oral use for 4 days. |
| Rivaroxaban 20 mg once daily | DRUG | One rivaroxaban 20 mg tablet administered once daily on Day 5. Interpretation by CTRL: Concentration type = Exact; Number = 20; unit=mg; route: oral use for 1 day. |
| Profilnine SD | DRUG | Single bolus dose of Profilnine SD 50 IU/kg administered by intravenous (IV) injection on Day 5. Interpretation by CTRL: Concentration type = Exact; Number = 50; unit=IU/kg; route: intraveous use. |
| Beriplex P/N | DRUG | Single bolus dose of Beriplex P/N 50 IU/kg administered by intravenous (IV) injection on Day 5 Interpretation by CTRL: Concentration type = Exact ; Number = 50; unit=IU/kg; route : intravenous use |
| Saline | OTHER | Single 100 cc bolus of saline administered by intravenous (IV) injection on Day 5. Interpretation by CTRL: Concentration type = Exact ; Number = 100; unit=cc; route : intravenous use use. |
Inclusion Criteria: * Have coagulation test results of PT, INR and aPTT that are within normal limits * Have a Body Mass Index (BMI; weight \[kg\]/height2 \[m\]2) between 18 and 30 kg/m2 (inclusive), and body weight between 50 and 100 kg * Have blood pressure (after the volunteer is supine \[lying ...