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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
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: Apixaban
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Apixaban
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 22
Study Start Date: September 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437839

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01437839     History of Changes
Other Study ID Numbers: B0661019
Study First Received: September 20, 2011
Last Updated: October 21, 2011
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Pfizer:
Food effect study
Pharmacokinetics
Apixaban

ClinicalTrials.gov processed this record on May 16, 2013