3-way cross-over single dose design evaluating bioavailability of 2 rifampicin-containing FDCs vs a single drug comparator in healthy volunteers

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

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