Bioavailability Study Comparing Modified Release To Immediate Release Apixaban Tablets In Healthy Volunteers

A Randomized, Open-Label, Single Dose, Four Way Cross-Over Bioavailability Study Comparing Three Modified Release Formulations Of Apixaban Tablets To Apixaban Immediate Release Tablets In Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00914641

Enrollment

Registered

2009-06-05

Start date

2009-06-30

Completion date

2009-08-31

Last updated

2009-08-25

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

Conditions

Thrombosis

Keywords

formulation; sustained release; modified release; extended release

Brief summary

To estimate the pharmacokinetics of apixaban when administered as three different modified release formulation tablets relative to that when apixaban is administered as an immediate release tablet

Interventions

DRUGApixaban IR

immediate release tablet, 10 mg, single dose

DRUGApixaban MR1

modified release tablet 1, 10 mg, single dose

DRUGApixaban MR2

modified release tablet 2, 10 mg, single dose

DRUGApixaban MR3

modified release tablet 3, 10 mg, single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male or female patients * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion criteria

* Any condition possibly affecting drug absorption * History or evidence of abnormal bleeding or clotting disorder

Design outcomes

Primary

Measure	Time frame
Apixaban PK: Cmax, C24, AUClast, AUCinf, Tmax, and half-life (t½)	96 hours
Safety and tolerability as determined by adverse event reporting, clinical laboratory results, vital signs, physical examinations, and ECGs.	per treatment period of 96 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026