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

Pfizer16 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Thrombosis

Interventions

Apixaban IRDRUG

immediate release tablet, 10 mg, single dose

Apixaban MR1DRUG

modified release tablet 1, 10 mg, single dose

Apixaban MR2DRUG

modified release tablet 2, 10 mg, single dose

Apixaban MR3

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Apixaban PK: Cmax, C24, AUClast, AUCinf, Tmax, and half-life (t½)

Time frame: 96 hours

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

Data from ClinicalTrials.gov

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