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Food Effect Study For Apixaban Commercial Image Tablets

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NCT01437839

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy volunteers

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01437839
Pfizer
Completed
Food Effect Study For Apixaban Commercial Image Tablets

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Pfizer Clinical Trials Contact Center

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[email protected]

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Food Effect Study For Apixaban Commercial Image Tablets
An Open Label, Randomized, 2-period Crossover Study Evaluating Single Dose Food Effect On Apixaban Commercial Image Tablets In Healthy Subjects
To evaluate the effect of food on the pharmacokinetics of apixaban administered as commercial image tablets.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy
  • 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)
  • Drug: 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)
  • Experimental: 1
    Period I: fasting state, Period II: fed state
    Intervention: Drug: Apixaban
  • Experimental: 2
    Period I: fed state, Period II: fasting state
    Intervention: Drug: Apixaban
Song Y, Chang M, Suzuki A, Frost RJ, Kelly A, LaCreta F, Frost C. Evaluation of Crushed Tablet for Oral Administration and the Effect of Food on Apixaban Pharmacokinetics in Healthy Adults. Clin Ther. 2016 Jul;38(7):1674-1685.e1. doi: 10.1016/j.clinthera.2016.05.004. Epub 2016 Jun 10.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
October 2011
October 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
 
NCT01437839
B0661019
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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