Phase 1 Bioavailability Study of Apixaban Solution Formulation Relative to Apixaban Tablets in Healthy Subjects
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/21/2016 |
| Start Date: | January 2010 |
| End Date: | March 2010 |
Study of Bioavailability of Apixaban Solution Formulation Relative to Apixaban Tablets in Healthy Subjects
The purpose of this study is to assess the oral bioavailability of Apixaban solution
formulation (Treatment B, 10 mg as 25 mL x 0.4 mg/mL) relative to Apixaban Phase 3 tablets
(Treatment A, 10 mg as 2 x 5 mg tablets) in healthy subjects.
formulation (Treatment B, 10 mg as 25 mL x 0.4 mg/mL) relative to Apixaban Phase 3 tablets
(Treatment A, 10 mg as 2 x 5 mg tablets) in healthy subjects.
Inclusion Criteria:
- Healthy subjects as determined by no clinically significant deviation from normal in
medical history, physical examination, ECGs, and clinical laboratory determinations
Exclusion Criteria:
- Any significant acute or chronic medical illness or relevant trauma (e.g., history of
chronic hypertension, bacterial endocarditis, hemorrhagic stroke, motor vehicle
accident resulting in significant head trauma or internal injuries)
- History or evidence of abnormal bleeding or coagulation disorder (e.g., easy bruising
or gingival bleeding, prolonged bleeding after dental extraction, postpartum, or
after trauma, wounds or surgery)
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