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

NCT ID: NCT00914641

Last Updated: 2009-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Apixaban Cross-over

Group Type OTHER

Apixaban IR

Intervention Type DRUG

immediate release tablet, 10 mg, single dose

Apixaban MR1

Intervention Type DRUG

modified release tablet 1, 10 mg, single dose

Apixaban MR2

Intervention Type DRUG

modified release tablet 2, 10 mg, single dose

Apixaban MR3

Intervention Type DRUG

modified release tablet 3, 10 mg, single dose

Interventions

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Apixaban IR

immediate release tablet, 10 mg, single dose

Intervention Type DRUG

Apixaban MR1

modified release tablet 1, 10 mg, single dose

Intervention Type DRUG

Apixaban MR2

modified release tablet 2, 10 mg, single dose

Intervention Type DRUG

Apixaban MR3

modified release tablet 3, 10 mg, single dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

New Haven, Connecticut, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CV185071

Identifier Type: -

Identifier Source: secondary_id

B0661007

Identifier Type: -

Identifier Source: org_study_id

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