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Bioavailability of Apixaban Sprinkle Compared to Apixaban Capsules

NCT03509883 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2020-01-23

Study results available
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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

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-26
Primary Completion
2018-06-15
Completion
2018-06-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03509883 on ClinicalTrials.gov