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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 Apixaban

Area 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 tests

Cmax 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:

For more information regarding BMS clinical trial participation, please visit 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

Page last updated: August 23, 2015

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