NCT02101112

Bioavailability of Apixaban Crushed Tablet

Relative Bioavailability of Crushed Apixaban Tablets Administered With Water or Apple Sauce Compared With Intact Tablet in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether the bioavailability of apixaban crushed tablets suspended in water or mixed with applesauce is similar to the bioavailability of apixaban whole tablets administered orally.

Detailed description

This study will investigate the bioavailability of apixaban administered as crushed tablets suspended in water and as crushed tablets mixed with applesauce compared with that of whole tablets. The study results may allow enhancement of the apixaban label to include alternative methods of apixaban administration, which may be of benefit to patients who have difficulty swallowing.

Conditions

• Thrombosis

Interventions

Type	Name	Description
DRUG	Apixaban

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2014-04-01
• Last updated: 2016-03-03
• Results posted: 2016-03-03