NCT00914641

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Thrombosis

Interventions

Type	Name	Description
DRUG	Apixaban IR	immediate release tablet, 10 mg, single dose
DRUG	Apixaban MR1	modified release tablet 1, 10 mg, single dose
DRUG	Apixaban MR2	modified release tablet 2, 10 mg, single dose
DRUG	Apixaban MR3	modified release tablet 3, 10 mg, single dose

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2009-06-05
• Last updated: 2009-08-25

Locations

1 site across 1 country: United States