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Bioavailability Study Comparing Modified Release To Immediate Release Apixaban Tablets In Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00914641
Recruitment Status : Completed
First Posted : June 5, 2009
Last Update Posted : August 25, 2009
Bristol-Myers Squibb
Information provided by:

Brief Summary:
To estimate the pharmacokinetics of apixaban when administered as three different modified release formulation tablets relative to that when apixaban is administered as an immediate release tablet

Condition or disease Intervention/treatment Phase
Thrombosis Drug: Apixaban IR Drug: Apixaban MR1 Drug: Apixaban MR2 Drug: Apixaban MR3 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Randomized, Open-Label, Single Dose, Four Way Cross-Over Bioavailability Study Comparing Three Modified Release Formulations Of Apixaban Tablets To Apixaban Immediate Release Tablets In Healthy Volunteers
Study Start Date : June 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots
Drug Information available for: Apixaban

Arm Intervention/treatment
Apixaban Cross-over Drug: Apixaban IR
immediate release tablet, 10 mg, single dose

Drug: Apixaban MR1
modified release tablet 1, 10 mg, single dose

Drug: Apixaban MR2
modified release tablet 2, 10 mg, single dose

Drug: Apixaban MR3
modified release tablet 3, 10 mg, single dose

Primary Outcome Measures :
  1. Apixaban PK: Cmax, C24, AUClast, AUCinf, Tmax, and half-life (t½) [ Time Frame: 96 hours ]
  2. Safety and tolerability as determined by adverse event reporting, clinical laboratory results, vital signs, physical examinations, and ECGs. [ Time Frame: per treatment period of 96 hours ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy male or female patients
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion Criteria:

  • Any condition possibly affecting drug absorption
  • History or evidence of abnormal bleeding or clotting disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00914641

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United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00914641    
Other Study ID Numbers: B0661007
First Posted: June 5, 2009    Key Record Dates
Last Update Posted: August 25, 2009
Last Verified: August 2009
Keywords provided by Pfizer:
formulation; sustained release; modified release; extended release
Additional relevant MeSH terms:
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Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action