Overview

TASK-002: Bioequivalence of Bedaquiline 400mg Administered in Crushed Form Compared to Tablet Form in Healthy Male and Female Adults Under Fed Conditions (BDQ Crush Study)

Status:
Completed

Trial end date:
2017-01-11

Target enrollment:

Participant gender:

Summary

This is a randomized, open-label, cross-over study comparing the bioequivalence of bedaquiline administered in whole tablet form versus bedaquiline administered in crushed (experimental) form in healthy adult volunteers.

Phase:

Early Phase 1

Details

Lead Sponsor:

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Collaborators:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)
US National Institute of Allergy and Infectious Diseases
US National Institute of Child Health and Human Development

Treatments:

Bedaquiline
Diarylquinolines