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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

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Apixaban Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Randomized, 2-period Crossover Study Evaluating Single Dose Food Effect On Apixaban Commercial Image Tablets In Healthy Subjects
Study Start Date : September 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Apixaban

Arm Intervention/treatment
Experimental: 1
Period I: fasting state, Period II: fed state
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)

Experimental: 2
Period I: fed state, Period II: fasting state
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)




Primary Outcome Measures :
  1. Cmax [ Time Frame: dosing to 3 days ]
  2. AUC(INF) [ Time Frame: dosing to 3 days ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01437839


Locations
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Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01437839    
Other Study ID Numbers: B0661019
First Posted: September 21, 2011    Key Record Dates
Last Update Posted: October 25, 2011
Last Verified: October 2011
Keywords provided by Pfizer:
Food effect study
Pharmacokinetics
Apixaban
Additional relevant MeSH terms:
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Apixaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants