Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Apixaban sprinkle · 1 trial · 1 indication
Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of concentration
Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of plasma concentration and time
Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of plasma concentration and time
| Arm | Type | Description |
|---|---|---|
| Apixaban sprinkle capsules followed by apixaban tablets | EXPERIMENTAL | Apixaban (BMS-562247) sprinkle capsules followed by apixaban tablets |
| Apixaban tablets followed by apixaban sprinkle capsules | ACTIVE_COMPARATOR | Apixaban (BMS-562247) tablets followed by apixaban sprinkle capsules |
| Name | Type | Description |
|---|---|---|
| Drug: Apixaban sprinkle capsules | DRUG | Single dose (25 x 0.1 mg capsules), oral administration |
| Experimental: Apixaban tablets followed by apixaban sprinkle capsules | DRUG | Apixaban sprinkle capsules Single dose (25 x 0.1 mg capsules), oral administration |
Inclusion Criteria: * Signed informed consent form. * Healthy male and female participants determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs (electrocardiograms), vital signs and clinical laboratory determinations. * Women of childb...
Apixaban sprinkle is an investigational sprinkle formulation of apixaban, a small molecule factor Xa (F10) inhibitor developed by Bristol-Myers Squibb Company (BMY). It is being studied as an alternative way to deliver apixaban, and the sprinkle capsules are also referred to as apixaban sprinkle capsules.
Apixaban sprinkle targets factor Xa, also known as F10, and acts as an inhibitor of this clotting enzyme. By inhibiting factor Xa, the drug is designed to reduce thrombin generation and blood clot formation, the same mechanism associated with apixaban.
Apixaban sprinkle is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is the sponsor associated with the clinical development of this sprinkle capsule formulation of apixaban.
Apixaban sprinkle is in Phase 1 clinical development. It is an investigational formulation and has been studied in a completed Phase 1 trial; it is not described as an approved product. The program includes one trial in total, which has finished, with no active trials ongoing.
Apixaban sprinkle has been evaluated in the Phase 1 trial NCT03509883, titled Bioavailability of Apixaban Sprinkle Compared to Apixaban Capsules. That trial enrolled 94 healthy adult volunteers in the United States, was randomized and active controlled, and its status is completed.
Yes, apixaban sprinkle and apixaban sprinkle capsules refer to the same investigational product. Both names describe the sprinkle capsule formulation of apixaban developed by Bristol-Myers Squibb Company, so searches using either name point to the same Phase 1 asset.