Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03509883 | Bioavailability of Apixaban Sprinkle Compared to Apixaban Capsules | PHASE1 | COMPLETED | 94 | — | — | Apr 26, 2018 | Jun 15, 2018 | Jan 23, 2020 | 1 | United States |
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...