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

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Cape Town
• Treatments: Isoniazid; Rifampin

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