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OpenTrials
Completed

NCT Number: NCT01437839

Food Effect Study For Apixaban Commercial Image Tablets

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

Completed

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Key information

Conditions

Healthy

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Singapore, 188770

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apixaban

Drug

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)

Primary outcomes

  1. Cmax

    Time frame: dosing to 3 days

  2. AUC(INF)

    Time frame: dosing to 3 days

Secondary outcomes

  1. AUC(tlqc)

    Time frame: dosing to 3 days

  2. Tmax

    Time frame: dosing to 3 days

  3. t1/2

    Time frame: dosing to 3 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 21, 2011
Registry last updated
Oct 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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