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

This study has been completed.

First Received: June 3, 2009 Last Updated: August 24, 2009 History of Changes

Sponsors and Collaborators:	Pfizer Bristol-Myers Squibb
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00914641

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 I

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
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:

Drug Information available for: Apixaban

U.S. FDA Resources

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

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by Pfizer:

formulation; sustained release; modified release; extended release

Study placed in the following topic categories:

Oxymetazoline
Embolism and Thrombosis
Phenylephrine
Embolism

Vascular Diseases
Healthy
Thrombosis

Additional relevant MeSH terms:

Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on September 03, 2009