NCT03032367

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
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group · Network
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a randomized, open-label, cross-over, bioequivalence study with two single treatment periods, separated by a 14-day wash-out period, conducted among 24 healthy adult males and females, who receive 400mg (4 x 100mg) bedaquiline orally in one of two sequences: either first in whole tablet form and second in crushed (experimental) form, or vice versa under fed conditions. The bioequivalence evaluation will be based on primary pharmacokinetic (pk) parameters affecting the extent of absorption, i.e., the bioavailability. If bioequivalence is not shown, the knowledge about the differences in bioavailability between whole and crushed tablets will be used for assessing the need of dose adjustment in children receiving the crushed form.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
DRUG	bedaquiline

Timeline

• Start date: 2016-11-10
• Primary completion: 2016-12-09
• Completion: 2017-01-11
• First posted: 2017-01-26
• Last updated: 2017-07-28

Locations

1 site across 1 country: South Africa