NCT03509883

Bioavailability of Apixaban Sprinkle Compared to Apixaban Capsules

A Study to Assess the Absorption of Apixaban (BMS-562247) Sprinkle Capsules Compared With Tablets in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the absorption of apixaban (BMS-562247) into the bloodstream of healthy volunteers, when administered as sprinkle capsules compared to tablets. Eligible participants will be randomly assigned to 1 of 2 treatment sequences and will receive a single oral dose of apixaban twice during the course of the study.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Drug: Apixaban sprinkle capsules	Single dose (25 x 0.1 mg capsules), oral administration
DRUG	Experimental: Apixaban tablets followed by apixaban sprinkle capsules	Apixaban sprinkle capsules Single dose (25 x 0.1 mg capsules), oral administration

Timeline

• Start date: 2018-04-26
• Primary completion: 2018-06-15
• Completion: 2018-06-15
• First posted: 2018-04-26
• Last updated: 2020-01-23
• Results posted: 2020-01-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study