Bioavailability of Apixaban Crushed Tablet
Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Thrombosis
Intervention: Apixaban (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s): Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
Summary
The purpose of this study is to determine whether the bioavailability of apixaban crushed
tablets suspended in water or mixed with applesauce is similar to the bioavailability of
apixaban whole tablets administered orally.
Clinical Details
Official title: Relative Bioavailability of Crushed Apixaban Tablets Administered With Water or Apple Sauce Compared With Intact Tablet in Healthy Subjects
Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Maximum observed plasma concentration of ApixabanArea under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Apixaban Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of Apixaban
Secondary outcome: Safety and tolerability of Apixaban measured by incidence of Adverse Events AEs, SAEs, and AEs leading to discontinuation; and results of vital signs, ECGs, physical examinations, and clinical laboratory testsCmax of Apixaban AUC(INF) of Apixaban AUC(0-T) of Apixaban Time of maximum observed plasma concentration (Tmax) of Apixaban Terminal plasma half-life (T-HALF) of Apixaban Relative bioavailability (Frel) of Apixaban
Detailed description:
This study will investigate the bioavailability of apixaban administered as crushed tablets
suspended in water and as crushed tablets mixed with applesauce compared with that of whole
tablets. The study results may allow enhancement of the apixaban label to include
alternative methods of apixaban administration, which may be of benefit to patients who have
difficulty swallowing.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
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www. BMSStudyConnect. com
Inclusion Criteria:
- Healthy participants as determined by no clinically significant deviation from normal
in findings of medical history, physical examination, electrocardiograms, vital
signs, and clinical laboratory tests.
- Women of childbearing potential allowed. Must be following highly effective methods
of contraception
Exclusion Criteria:
- Any significant acute or chronic medical illness
- History of significant head injury within the last 2 years, including individuals
with base of skull fractures
- Any major surgery within 4 weeks of study drug administration or anticipated within 2
weeks after completion of the study
- Any gastrointestinal (GI) surgery or GI disease that could impact absorption of study
drug
- History of Gilbert's Syndrome
- Inability to tolerate oral medication
- Inability to be venipunctured and/or tolerate venous access
- Use of tobacco- or nicotine-containing products (including, but not limited to,
cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or
nicotine gum) within 6 months prior to study drug administration
- Any laboratory test results outside of the range of normal, confirmed by repeat
results of:
- Platelet count <150,000 cells/µL
- Activated partial thromboplastin time >upper limit of normal (ULN)
- International normalized ratio >ULN
- Alanine aminotransferase >ULN
- Aspartate aminotransferase >ULN
- Total bilirubin >ULN
- Serum creatinine ≥1. 5 mg/dL
- Hemoglobin
- Hematocrit
Locations and Contacts
Additional Information
BMS Clinical Trial Information BMS clinical trial educational resource Investigator Inquiry form FDA Safety Alerts and Recalls
Starting date: March 2014
Last updated: April 10, 2015
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