Food Effect Study For Apixaban Commercial Image Tablets

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Apixaban

• Registration Number: NCT01437839
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-20
• Study First Submitted QC: 2011-09-20
• Study First Posted: 2011-09-21
• Status Verified: 2011-10
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Last Update Submitted: 2011-10-21
• Last Update Posted: 2011-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Apixaban	Period I: fed state, Period II: fasting state
1	Apixaban	Period I: fasting state, Period II: fed state

Primary Outcome Measures

Name	Time	Method
Cmax	dosing to 3 days
AUC(INF)	dosing to 3 days

Secondary Outcome Measures

Name	Time	Method
AUC(tlqc)	dosing to 3 days
Tmax	dosing to 3 days
t1/2	dosing to 3 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore