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

Phase 1

Completed

• Conditions: Thrombosis
• Interventions: Drug: Apixaban IR; Drug: Apixaban MR1; Drug: Apixaban MR2; Drug: Apixaban MR3

• Registration Number: NCT00914641
• Lead Sponsor: Pfizer

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-03
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-05
• Status Verified: 2009-08
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Last Update Submitted: 2009-08-24
• Last Update Posted: 2009-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Apixaban Cross-over	Apixaban IR	-
Apixaban Cross-over	Apixaban MR1	-
Apixaban Cross-over	Apixaban MR2	-
Apixaban Cross-over	Apixaban MR3	-

Primary Outcome Measures

Name	Time	Method
Apixaban PK: Cmax, C24, AUClast, AUCinf, Tmax, and half-life (t½)	96 hours
Safety and tolerability as determined by adverse event reporting, clinical laboratory results, vital signs, physical examinations, and ECGs.	per treatment period of 96 hours

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States