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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)

NCT03032367 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-07-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

bedaquiline

Sponsors & Collaborators

  • US National Institute of Allergy and Infectious Diseases

    collaborator UNKNOWN

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • International Maternal Pediatric Adolescent AIDS Clinical Trials Group

    lead NETWORK

Principal Investigators

  • Jeannine du Bois, MD · TASK Clinical Research Centre

  • Anthony Garcia-Pratts, MD · Desmond Tutu TB Centre, Stellenbosch University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-11-10
Primary Completion
2016-12-09
Completion
2017-01-11

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases
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 NCT03032367 on ClinicalTrials.gov