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

Primary Purpose

Thrombosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Apixaban IR
Apixaban MR1
Apixaban MR2
Apixaban MR3
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Thrombosis focused on measuring formulation; sustained release; modified release; extended release

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Apixaban Cross-over

Arm Description

Outcomes

Primary Outcome Measures

Apixaban PK: Cmax, C24, AUClast, AUCinf, Tmax, and half-life (t½)
Safety and tolerability as determined by adverse event reporting, clinical laboratory results, vital signs, physical examinations, and ECGs.

Secondary Outcome Measures

Full Information

First Posted
June 3, 2009
Last Updated
August 24, 2009
Sponsor
Pfizer
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00914641
Brief Title
Bioavailability Study Comparing Modified Release To Immediate Release Apixaban Tablets In Healthy Volunteers
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis
Keywords
formulation; sustained release; modified release; extended release

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apixaban Cross-over
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Apixaban IR
Intervention Description
immediate release tablet, 10 mg, single dose
Intervention Type
Drug
Intervention Name(s)
Apixaban MR1
Intervention Description
modified release tablet 1, 10 mg, single dose
Intervention Type
Drug
Intervention Name(s)
Apixaban MR2
Intervention Description
modified release tablet 2, 10 mg, single dose
Intervention Type
Drug
Intervention Name(s)
Apixaban MR3
Intervention Description
modified release tablet 3, 10 mg, single dose
Primary Outcome Measure Information:
Title
Apixaban PK: Cmax, C24, AUClast, AUCinf, Tmax, and half-life (t½)
Time Frame
96 hours
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0661007&StudyName=Bioavailability%20Study%20Comparing%20Modified%20Release%20To%20Immediate%20Release%20Apixaban%20Tablets%20In%20Healthy%20Volunteers
Description
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Bioavailability Study Comparing Modified Release To Immediate Release Apixaban Tablets In Healthy Volunteers

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