Healthy Subjects Clinical Trial
Official title:
Bioavailability of Apixaban Oral Solution Administered Through a Nasogastric Tube in the Presence of Boost® Plus and Apixaban Administered as Crushed Tablet Through a Nasogastric Tube Relative to Apixaban Oral Solution in Healthy Subjects
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | November 2011 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Healthcare Discoveries, LLC D/B/A Icon Development Solutions | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb | Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bioavailability of Apixaban oral solution (OS) administered through NGT in the presence of Boost Plus® relative to Apixaban solution administered orally in healthy subjects | Up to Day 12 | No | |
Secondary | Bioavailability of Apixaban crushed tablet administered through NGT relative to Apixaban solution administered orally in healthy subjects | Up to Day 12 | No | |
Secondary | Maximum observed plasma concentration (Cmax) of Apixaban will be derived from plasma concentration versus time | 48 timepoints up to Day 12 | No | |
Secondary | Time of maximum observed plasma concentration (Tmax) of Apixaban will be derived from plasma concentration versus time | 48 timepoints up to Day 12 | No | |
Secondary | Area under the plasma concentration-time curve from zero to the last time of last quantifiable concentration [AUC(0-T)] of Apixaban will be derived from plasma concentration versus time | 48 timepoints up to Day 12 | No | |
Secondary | Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Apixaban will be derived from plasma concentration versus time | 48 timepoints up to Day 12 | No | |
Secondary | Plasma elimination half-life (T-HALF) of Apixaban will be derived from plasma concentration versus time | 48 timepoints up to Day 12 | No | |
Secondary | Relative bioavailability as calculated by ratio of AUC(INF) (Frel) of Apixaban will be derived from plasma concentration versus time | 48 timepoints up to Day 12 | No | |
Secondary | Safety assessed by incidence of adverse events, results of vital sign measurements, electrocardiograms (ECGs), physical examinations, and clinical laboratory tests | Up to Day 12 | Yes |
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