Phase 1
Completed N=14
Phase 1 Bioavailability Study of Apixaban Solution Formulation Relative to Apixaban Tablets in Healthy Subjects
Healthy Volunteers
Source: ClinicalTrials.gov NCT02034565 ↗
Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcomePrimary: Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban — 293.994; 287.164 ng/mL
Summary
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 tablets (Treatment A, 10 mg as 2 x 5 mg tablets) in healthy subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban |
293.994; 287.164 | — |
| PRIMARY Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinite Time AUC(INF) of Apixaban |
2712.477; 2848.968 | — |
| PRIMARY Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban |
2668.310; 2784.366 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs), Treatment-Related Adverse Events (AEs), Deaths or Discontinuation of Study Drug Due to AEs |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities |
1; 1; 1; 1; 0; 1 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02034565). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.