Food Effect Study For Apixaban Commercial Image Tablets

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Apixaban

Study type: Interventional

Funder types: Industry

Identifiers

NCT01437839

B0661019

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

1

Experimental group

Description:

Period I: fasting state, Period II: fed state

Treatment:

Drug: Apixaban

Drug: Apixaban

2

Experimental group

Description:

Period I: fed state, Period II: fasting state

Treatment:

Drug: Apixaban

Drug: Apixaban