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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Thrombosis

Treatments: Drug: Apixaban MR3; Drug: Apixaban IR; Drug: Apixaban MR1; Drug: Apixaban MR2

Study type: Interventional

Funder types: Industry

Identifiers

NCT00914641

CV185071

B0661007

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

16 participants in 1 patient group

Apixaban Cross-over

Other group

Treatment:

Drug: Apixaban IR

Drug: Apixaban MR2

Drug: Apixaban MR1

Drug: Apixaban MR3