Tuberculosis
Conditions
Brief summary
3-way cross-over single dose design evaluating bioavailability of 2 rifampicin-containing FDCs vs a single drug comparator in healthy volunteers
Detailed description
In this study the 4- and 2-drug FDCs (for intensive and continuation phases respectively) widely used within the South African treatment program will be evaluated in a comparative bioavailability study against a single drug rifampicin product registered by the South African Medicines Control Council. A three-way, single dose, cross-over study will be conducted in 24 healthy volunteers
Interventions
DRUGRimactane
150 mg capsules, Sandoz MCC registration # A/20.2.3/784
DRUGRifafour 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.
DRUGRimactazid 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.
Sponsors
University of Cape Town
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion * You need to be between the ages of 18-55 years * Have a Body mass index (BMI) of 19-30 kg/m2 * Weigh 45 kg or more * Be a non-smoker * Be found to be in normal health on history and examination * To have normal blood and urine test results * If you are a woman of child-bearing age, you need to be prepared to not have sexual intercourse, or use a safe form of contraception, until the end of the study Exclusion * You are unable to fully understand and comply with the study procedures, requirements and time commitments. * Are currently enrolled in any other study evaluating drugs, biologics or devices * You have TB, or have had TB before * You abuse or have abused drugs or alcohol * You have, or have had, drug allergy, severe asthma, or active or recurrent allergic disease * You are pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax | 1 year |
Other
| Measure | Time frame |
|---|---|
| AUC to 12 h | 1 year |
| AUC to infinity | 1 year |
Countries
South Africa
Outcome results
None listed