Skip to main content
OpenTrials
Completed

NCT Number: NCT00914641

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thrombosis Cardiovascular Diseases Embolism and Thrombosis Vascular Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apixaban IR

Drug

immediate release tablet, 10 mg, single dose

Apixaban MR1

Drug

modified release tablet 1, 10 mg, single dose

Apixaban MR2

Drug

modified release tablet 2, 10 mg, single dose

Apixaban MR3

Drug

modified release tablet 3, 10 mg, single dose

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 5, 2009
Registry last updated
Aug 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.