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NCT00914641 Clinical Trial

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

Thrombosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00914641
Other study ID # B0661007
Secondary ID CV185071
Status Completed
Phase Phase 1
First received June 3, 2009
Last updated August 24, 2009
Start date June 2009
Est. completion date August 2009

Study information
Verified date August 2009
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• Apixaban IR
immediate release tablet, 10 mg, single dose
• Apixaban MR1
modified release tablet 1, 10 mg, single dose
• Apixaban MR2
modified release tablet 2, 10 mg, single dose
• Apixaban MR3
modified release tablet 3, 10 mg, single dose

Locations
Country Name City State
United States Pfizer Investigational Site New Haven Connecticut

Sponsors (2)
Lead Sponsor Collaborator
Pfizer Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Apixaban PK: Cmax, C24, AUClast, AUCinf, Tmax, and half-life (t½) 96 hours No
Primary Safety and tolerability as determined by adverse event reporting, clinical laboratory results, vital signs, physical examinations, and ECGs. per treatment period of 96 hours Yes
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