Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rivaroxaban in ODT form · 2 trials · 1 indication
Maximum observed concentration
Area under the concentration versus time curve from time 0 to the last data point \> lower limit of quantitation
| Arm | Type | Description |
|---|---|---|
| Test A: 10 mg ODT with water, then 10 mg film-coated tablet | EXPERIMENTAL | Participants received one single dose of 10 mg rivaroxaban orally disintegrating tablet (ODT) with water in the fasted state. After a washing period of 5 days, participants received one single oral dose of 10 mg rivaroxaban film-coated tablet in the fasted state |
| Test A: 10 mg film-coated tablet, then 10 mg ODT with water | EXPERIMENTAL | Participants received one single dose of 10 mg rivaroxaban film-coated tablet in the fasted state. After a washing period of 5 days, participants received one single oral dose of 10 mg rivaroxaban orally disintegrating tablet (ODT) with water in the fasted state |
| Test B: 10 mg ODT without water, then 10 film-coated tablet | EXPERIMENTAL | Participants received one single dose of 10 mg rivaroxaban orally disintegrating tablet (ODT) without water in the fasted state. After a washing period of 5 days, participants received one single oral dose of 10 mg rivaroxaban film-coated tablet in the fasted state |
| Test B: 10 mg film-coated tablet, then 10 mg ODT without water | EXPERIMENTAL | Participants received one single dose of 10 mg rivaroxaban film-coated tablet in the fasted state. After a washing period of 5 days, participants received one single oral dose of 10 mg rivaroxaban orally disintegrating tablet (ODT) without water in the fasted state |
| Test C: 15 mg ODT with water, then 15 mg film-coated tablet | EXPERIMENTAL | Participants received one single dose of 15 mg rivaroxaban orally disintegrating tablet (ODT) with water in the fasted state. After a washing period of 5 days, participants received one single oral dose of 15 mg rivaroxaban film-coated tablet in the fasted state |
| Test C: 15 mg film-coated tablet, then 15 mg ODT with water | EXPERIMENTAL | Participants received one single dose of 15 mg rivaroxaban film-coated tablet in the fasted state. After a washing period of 5 days, participants received one single oral dose of 15 mg rivaroxaban orally disintegrating tablet (ODT) with water in the fasted state |
| Test D: 15 mg ODT without water, then 15 film-coated tablet | EXPERIMENTAL | Participants received one single dose of 15 mg rivaroxaban orally disintegrating tablet (ODT) without water in the fasted state. After a washing period of 5 days, participants received one single oral dose of 15 mg rivaroxaban film-coated tablet in the fasted state |
| Test D: 15 mg film-coated tablet, then 15 mg ODT without water | EXPERIMENTAL | Participants received one single dose of 15 mg rivaroxaban film-coated tablet in the fasted state. After a washing period of 5 days, participants received one single oral dose of 15 mg rivaroxaban orally disintegrating tablet (ODT) without water in the fasted state |
| Name | Type | Description |
|---|---|---|
| Rivaroxaban (BAY 59-7939, Xarelto) in ODT form | DRUG | 10 mg as 1 x 10 mg orally disintegrating tablet (ODT) |
| Rivaroxaban (BAY 59-7939, Xarelto) in film-coated form | DRUG | 10 mg as 1 x 10 mg film-coated tablet |
Inclusion Criteria: \- Japanese healthy male subjects, aged 20 to 40 years (inclusive), with body mass index 17.6 to 26.4 kg/m² Exclusion Criteria: * Subject with incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and e...
Rivaroxaban in ODT form is an orally disintegrating tablet formulation of rivaroxaban, a small molecule factor Xa (F10) inhibitor developed by Bayer AG. It is being studied in Phase 1 clinical pharmacology trials in Japan to compare its bioavailability with the standard film-coated tablet formulation of Xarelto.
Rivaroxaban in ODT form targets factor Xa (F10), a key enzyme in the coagulation cascade. By inhibiting factor Xa, it reduces thrombin generation and blood clot formation. This is the same mechanism as the approved film-coated tablet formulation of rivaroxaban.
Rivaroxaban in ODT form is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer is the originator of rivaroxaban, marketed as Xarelto.
Rivaroxaban in ODT form is in Phase 1 clinical development. Two Phase 1 trials have been completed, both in Japanese healthy male adult subjects, evaluating bioequivalence against the film-coated tablet. It is investigational and not approved in this orally disintegrating tablet form.
Rivaroxaban in ODT form has been studied in two completed Phase 1 trials: NCT04511637, which compared 15 mg orally disintegrating tablets with film-coated tablets, and NCT04511611, which compared 10 mg formulations. Both enrolled 80 Japanese healthy male adults and assessed bioequivalence.
Rivaroxaban in ODT form contains the same active ingredient as Xarelto (rivaroxaban, also known as BAY 59-7939), but it is a distinct orally disintegrating tablet formulation. Xarelto is the approved film-coated tablet brand; the ODT version is an investigational alternative being tested for bioequivalence.