Text Size

Food Effect Study For Apixaban Commercial Image Tablets

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01437839
First received: September 20, 2011
Last updated: October 21, 2011
Last verified: October 2011
History of Changes

September 20, 2011
October 21, 2011
September 2011
October 2011   (final data collection date for primary outcome measure)
  • Cmax [ Time Frame: dosing to 3 days ] [ Designated as safety issue: Yes ]
  • AUC(INF) [ Time Frame: dosing to 3 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01437839 on ClinicalTrials.gov Archive Site
  • AUC(tlqc) [ Time Frame: dosing to 3 days ] [ Designated as safety issue: Yes ]
  • Tmax [ Time Frame: dosing to 3 days ] [ Designated as safety issue: Yes ]
  • t1/2 [ Time Frame: dosing to 3 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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
Not Provided

*   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
Both
21 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01437839
B0661019
No
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