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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00914641
First received: June 3, 2009
Last updated: August 24, 2009
Last verified: August 2009
  Purpose

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
Thrombosis
Drug: Apixaban IR
Drug: Apixaban MR1
Drug: Apixaban MR2
Drug: Apixaban MR3
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00914641

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00914641     History of Changes
Other Study ID Numbers: B0661007, CV185071
Study First Received: June 3, 2009
Last Updated: August 24, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014