NCT01437839

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2011

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 25, 2011

Status Verified

October 1, 2011

Enrollment Period

1 month

First QC Date

September 20, 2011

Last Update Submit

October 21, 2011

Conditions

Healthy

Keywords

Food effect studyPharmacokineticsApixaban

Outcome Measures

Primary Outcomes (2)

  • Cmax

    dosing to 3 days

  • AUC(INF)

    dosing to 3 days

Secondary Outcomes (3)

  • AUC(tlqc)

    dosing to 3 days

  • Tmax

    dosing to 3 days

  • t1/2

    dosing to 3 days

Study Arms (2)

1

EXPERIMENTAL

Period I: fasting state, Period II: fed state

Drug: Apixaban

2

EXPERIMENTAL

Period I: fed state, Period II: fasting state

Drug: Apixaban

Interventions

ApixabanDRUG

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)

1

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Singapore, 188770, Singapore

Location

Related Publications (1)

  • 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.

    PMID: 27292282DERIVED

Related Links

MeSH Terms

Interventions

apixaban

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2011

First Posted

September 21, 2011

Study Start

September 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

October 25, 2011

Record last verified: 2011-10

Locations

SG(1)