Phase 1
Completed N=21
Phase 1 Oral Solution and Crushed Tablet Relative Bioavailability Study of Apixaban When Administered Through a Nasogastric Tube in Healthy Subjects
Healthy Subjects
Source: ClinicalTrials.gov NCT02034591 ↗
Enrolled (actual)
21
Serious AEs
1.6%
Results posted
Jun 2016
Primary outcomePrimary: Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban — 179.116; 122.145 ng/mL
Summary
The purpose of this study is to assess the bioavailability of Apixaban oral solution administered through an Nasogastric Tube (NGT) in the presence of Boost® Plus and Apixaban administered as crushed tablet through a nasogastric tube relative to Apixaban solution administered orally in healthy subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban |
179.116; 158.371 | — |
| 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 |
1397.666; 1136.380 | — |
| 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 |
1372.836; 1300.728 | — |
| SECONDARY Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban |
179.116; 158.371 | — |
| SECONDARY Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Apixaban |
1397.666; 1327.248 | — |
| SECONDARY 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 |
1372.836; 1300.728 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths or Discontinuation of Study Drug Due to AEs |
0; 0; 1; 0; 1; 1 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities |
0; 1; 0; 1; 0; 0 | — |
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
- Any history or evidence of abnormal bleeding or coagulation disorders, intracranial hemorrhage, or abnormal bleeding (including heavy menstrual bleeding that has resulted in anemia within the past 1 year) or coagulation disorders in a first degree relative
Data sourced from ClinicalTrials.gov (NCT02034591). 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.