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NCT01437839 Clinical Trial

Food Effect Study For Apixaban Commercial Image Tablets

Healthy Clinical Trial

Official title:
An Open Label, Randomized, 2-period Crossover Study Evaluating Single Dose Food Effect On Apixaban Commercial Image Tablets In Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01437839
Other study ID # B0661019
Secondary ID
Status Completed
Phase Phase 1
First received September 20, 2011
Last updated October 21, 2011
Start date September 2011
Est. completion date October 2011

Study information
Verified date October 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Singapore: Health Sciences Authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 45 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Apixaban
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)
• Apixaban
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)

Locations
Country Name City State
Singapore Pfizer Investigational Site Singapore

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cmax dosing to 3 days Yes
Primary AUC(INF) dosing to 3 days Yes
Secondary AUC(tlqc) dosing to 3 days Yes
Secondary Tmax dosing to 3 days Yes
Secondary t1/2 dosing to 3 days Yes
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