Pharmacokinetics of Antituberculosis Drugs in Breastfeeding Women

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2026

Conditions
Tuberculosis InfectionHealthy VolunteerBreastfeeding
Interventions
DRUG

Standard dose rifampicin

Single-dose rifampicin at 10 mg/kg body weight

DRUG

High dose rifampicin

Single-dose rifampicin at 20 mg/kg body weight

DRUG

Standard dose isoniazid

Single-dose isoniazid at 5 mg/kg body weight

DRUG

Standard dose levofloxacin

Single-dose levofloxacin at 10-15 mg/kg body weight

DRUG

Standard dose rifapentine

Single-dose rifapentine at 10 mg/kg body weight

DRUG

Standard dose bedaquiline

Single-dose bedaquiline at 400 mg

Trial Locations (1)

40161

Universitas Padjadjaran, Klinik Penelitian Tuberculosis (TB Research Clinic), Bandung

All Listed Sponsors
collaborator

Faculty of Medicine Universitas Padjadjaran

UNKNOWN

lead

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER