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 the small molecule drug rivaroxaban, developed by Bayer AG. It is being studied for clinical pharmacology purposes, specifically to compare its bioequivalence with the film-coated tablet version of rivaroxaban (Xarelto) in healthy Japanese male subjects.
Rivaroxaban in ODT form is used for clinical pharmacology studies, specifically to evaluate bioequivalence between the orally disintegrating tablet and the film-coated tablet of rivaroxaban at doses of 10 mg and 15 mg. These studies are conducted in healthy Japanese male adult subjects.
Rivaroxaban in ODT form is developed by Bayer AG, a German pharmaceutical company. Bayer's ticker symbol is BAYRY. The company is conducting clinical trials to compare this orally disintegrating tablet formulation with the standard film-coated tablet of rivaroxaban.
Rivaroxaban in ODT form is in Phase 1 clinical development. Two Phase 1 trials have been completed, each enrolling 80 healthy Japanese male subjects. The drug is investigational and has not been approved for marketing.
Rivaroxaban in ODT form has two completed Phase 1 trials: NCT04511611, comparing bioequivalence of 10 mg orally disintegrating and film-coated tablets, and NCT04511637, comparing bioequivalence of 15 mg formulations. Both trials enrolled 80 healthy Japanese male adults aged 20 years and older.
Rivaroxaban in ODT form is a new formulation of the same active ingredient as Xarelto, which is rivaroxaban. The orally disintegrating tablet is being studied to confirm it is bioequivalent to the existing film-coated Xarelto tablet at 10 mg and 15 mg doses.