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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 October 16, 2014