NCT02953847View on ClinicalTrials.gov

The Bioavailability of Rifampicin in (FDCs) Widely Used in South Africa to Treat Drug-susceptible (TB)

PHASE1CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

November 30, 2016

Primary Completion Date

February 28, 2017

Study Completion Date

February 28, 2017

Conditions
Tuberculosis
Interventions
DRUG

Rimactane

150 mg capsules, Sandoz MCC registration # A/20.2.3/784

DRUG

Rifafour e-275

Rifampicin/isoniazid/pyrazinamide/ethambutol 150/75/400/275 mg This 4-drug FDC is the most widely used 4-drug FDC in South Africa with an estimated 100% of the SA DOH tender.

DRUG

Rimactazid 150/75

Rifampicin/isoniazid 150/75 mg This 2-drug FDC is one of 2 widely used 2-drug FDCs in South Africa, with an estimated 30% of the SA DOH tender. Rifinah® made by Sanofi-Aventis holds about 70% of the tender, however as the Sanofi-Aventis 4-drug FDC will also be evaluated.

Trial Locations (1)

7725

Clinical Research Centre, Cape Town

All Listed Sponsors
lead

University of Cape Town

OTHER

NCT02953847 - The Bioavailability of Rifampicin in (FDCs) Widely Used in South Africa to Treat Drug-susceptible (TB) | Biotech Hunter | Biotech Hunter