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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01437839

Enrollment

Registered

2011-09-21

Start date

2011-09-30

Completion date

2011-10-31

Last updated

2011-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Food effect study, Pharmacokinetics, Apixaban

Brief summary

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

Interventions

DRUGApixaban

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)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Cmax	dosing to 3 days
AUC(INF)	dosing to 3 days

Secondary

Measure	Time frame
Tmax	dosing to 3 days
t1/2	dosing to 3 days
AUC(tlqc)	dosing to 3 days

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026