Food Effect Study For Apixaban Commercial Image Tablets

Phase 1CompletedNCT01437839

Pfizer22 enrolled

Overview

To evaluate the effect of food on the pharmacokinetics of apixaban administered as commercial image tablets.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

ApixabanDRUG

Period I: 1 x 5 mg Commercial Image Tablet in fasting state(single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period), Period II: 1 x 5 mg Commercial Image Tablet in fed state (single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period)

ApixabanDRUG

Period I: 1 x 5 mg Commercial Image Tablet in fed state(single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period), Period II: 1 x 5 mg Commercial Image Tablet in fasting state (single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period)

Eligibility

Sex: ALLMin age: 21 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy volunteers Exclusion Criteria: * History or evidence of abnormal bleeding or coagulation disorder (eg, easy bruising or gingival bleeding, prolonged bleeding after dental extraction, postpartum, or after trauma, wounds or surgery) and/or having a first degree relative under 50 years of age with a history of abnormal bleeding or coagulation disorder

Locations (1)

Pfizer Investigational Site

Singapore, Singapore

Outcomes

Primary Outcomes

Cmax

Time frame: dosing to 3 days

AUC(INF)

Time frame: dosing to 3 days

Secondary Outcomes

AUC(tlqc)

Time frame: dosing to 3 days

Tmax

Time frame: dosing to 3 days

t1/2

Time frame: dosing to 3 days

Data from ClinicalTrials.gov

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