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Trial record 1 of 1 for:    NCT01437839
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Food Effect Study For Apixaban Commercial Image Tablets

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ClinicalTrials.gov Identifier: NCT01437839
Recruitment Status : Completed
First Posted : September 21, 2011
Last Update Posted : October 25, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 20, 2011
First Posted Date  ICMJE September 21, 2011
Last Update Posted Date October 25, 2011
Study Start Date  ICMJE September 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2011)
  • Cmax [ Time Frame: dosing to 3 days ]
  • AUC(INF) [ Time Frame: dosing to 3 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01437839 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2011)
  • AUC(tlqc) [ Time Frame: dosing to 3 days ]
  • Tmax [ Time Frame: dosing to 3 days ]
  • t1/2 [ Time Frame: dosing to 3 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Food Effect Study For Apixaban Commercial Image Tablets
Official Title  ICMJE An Open Label, Randomized, 2-period Crossover Study Evaluating Single Dose Food Effect On Apixaban Commercial Image Tablets In Healthy Subjects
Brief Summary To evaluate the effect of food on the pharmacokinetics of apixaban administered as commercial image tablets.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 20, 2011)
22
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01437839
Other Study ID Numbers  ICMJE B0661019
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP