Bioavailability of Apixaban Crushed Tablet
Overview[ - collapse ][ - ]
Purpose | The purpose of this study is to determine if the bioavailability of Apixaban crushed tablets suspended in water or mixed with applesauce is similar to the bioavailability of Apixaban whole tablets administered orally. |
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Condition | Thrombosis |
Intervention | Drug: Apixaban |
Phase | Phase 1 |
Sponsor | Bristol-Myers Squibb |
Responsible Party | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier | NCT02101112 |
First Received | March 28, 2014 |
Last Updated | March 28, 2014 |
Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | March 28, 2014 |
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Last Updated Date | March 28, 2014 |
Start Date | March 2014 |
Estimated Primary Completion Date | May 2014 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Bioavailability of Apixaban Crushed Tablet |
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Official Title | Relative Bioavailability of Crushed Apixaban Tablets Administered With Water or Apple Sauce Compared With Intact Tablet in Healthy Subjects |
Brief Summary | The purpose of this study is to determine if the bioavailability of Apixaban crushed tablets suspended in water or mixed with applesauce is similar to the bioavailability of Apixaban whole tablets administered orally. |
Detailed Description | Primary Purpose: Other: This study will investigate the bioavailability of Apixaban when administered as crushed tablets suspended in water and as crushed tablets mixed with applesauce compared to whole tablets. The results of this study may allow enhancement of the Apixaban label to include alternative methods of administration of Apixaban tablet; this may be of benefit to patients who have difficulty swallowing |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label |
Condition | Thrombosis |
Intervention | Drug: Apixaban Other Names: Eliquis® |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Not yet recruiting |
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Estimated Enrollment | 33 |
Estimated Completion Date | May 2014 |
Estimated Primary Completion Date | May 2014 |
Eligibility Criteria | For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), vital signs, and clinical laboratory determinations - 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 subjects 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 of the following laboratory results outside of the ranges specified below prior to study drug administration, confirmed by repeat: - Platelet count <150,000 cells/µL - Activated partial thromboplastin time (aPTT) >upper limit of normal (ULN) - International normalized ratio (INR) >ULN - Alanine aminotransferase (ALT) >ULN - Aspartate aminotransferase (AST) >ULN - Total bilirubin >ULN - Serum creatinine ≥1.5 mg/dL - Hemoglobin - Hematocrit |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
NCT Number | NCT02101112 |
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Other Study ID Numbers | CV185-292 |
Has Data Monitoring Committee | No |
Information Provided By | Bristol-Myers Squibb |
Study Sponsor | Bristol-Myers Squibb |
Collaborators | Not Provided |
Investigators | Study Director: Bristol-Myers Squibb Bristol-Myers Squibb |
Verification Date | March 2014 |