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

This study has been completed.
Bristol-Myers Squibb
Information provided by:
Pfizer Identifier:
First received: June 3, 2009
Last updated: August 24, 2009
Last verified: August 2009
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 Intervention Phase
Drug: Apixaban IR
Drug: Apixaban MR1
Drug: Apixaban MR2
Drug: Apixaban MR3
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Apixaban PK: Cmax, C24, AUClast, AUCinf, Tmax, and half-life (t½) [ Time Frame: 96 hours ]
  • 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 ]

Enrollment: 16
Study Start Date: June 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00914641

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00914641     History of Changes
Other Study ID Numbers: B0661007
Study First Received: June 3, 2009
Last Updated: August 24, 2009

Keywords provided by Pfizer:
formulation; sustained release; modified release; extended release

Additional relevant MeSH terms:
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants processed this record on April 28, 2017