The Bioavailability of Rifampicin in (FDCs) Widely Used in South Africa to Treat Drug-susceptible (TB) (BIO3FDC)

University of Cape Town (UCT)

Status and phase: Completed; Phase 1

Conditions: Tuberculosis

Treatments: Drug: Rimactane; Drug: Rifafour e-275; Drug: Rimactazid 150/75

Study type: Interventional

Funder types: Other

Identifiers

NCT02953847

BIO3FDC

Details and patient eligibility

About

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

Full 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

Enrollment: 21 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 6 patient groups

sequence 1

Other group

Description:

Rifafour e-275®, Sanofi-Aventis /Rimactazid 150/75, Sandoz/ Rimactane® 150 mg capsules, Sandoz - 24 healthy volunteers will receive single doses of the 3 rifampicin containing products with a washout of 14 days between doses. Each volunteer will be randomised to receive the 3 doses in one of 6 sequences

Treatment:

Drug: Rimactazid 150/75

Drug: Rifafour e-275

Drug: Rimactane

sequence 2

Other group

Description:

Rifafour e-275®, Sanofi-Aventis /Rimactazid 150/75, Sandoz/ Rimactane® 150 mg capsules, Sandoz - 24 healthy volunteers will receive single doses of the 3 rifampicin containing products with a washout of 14 days between doses. Each volunteer will be randomised to receive the 3 doses in one of 6 sequences

Treatment:

Drug: Rimactazid 150/75

Drug: Rifafour e-275

Drug: Rimactane

sequence 3

Other group

Description:

Rifafour e-275®, Sanofi-Aventis /Rimactazid 150/75, Sandoz/ Rimactane® 150 mg capsules, Sandoz - 24 healthy volunteers will receive single doses of the 3 rifampicin containing products with a washout of 14 days between doses. Each volunteer will be randomised to receive the 3 doses in one of 6 sequences

Treatment:

Drug: Rimactazid 150/75

Drug: Rifafour e-275

Drug: Rimactane

sequence 4

Other group

Description:

Rifafour e-275®, Sanofi-Aventis /Rimactazid 150/75, Sandoz/ Rimactane® 150 mg capsules, Sandoz - 24 healthy volunteers will receive single doses of the 3 rifampicin containing products with a washout of 14 days between doses. Each volunteer will be randomised to receive the 3 doses in one of 6 sequences

Treatment:

Drug: Rimactazid 150/75

Drug: Rifafour e-275

Drug: Rimactane

sequence 5

Other group

Description:

Rifafour e-275®, Sanofi-Aventis /Rimactazid 150/75, Sandoz/ Rimactane® 150 mg capsules, Sandoz - 24 healthy volunteers will receive single doses of the 3 rifampicin containing products with a washout of 14 days between doses. Each volunteer will be randomised to receive the 3 doses in one of 6 sequences

Treatment:

Drug: Rimactazid 150/75

Drug: Rifafour e-275

Drug: Rimactane

sequence 6

Other group

Description:

Rifafour e-275®, Sanofi-Aventis /Rimactazid 150/75, Sandoz/ Rimactane® 150 mg capsules, Sandoz - 24 healthy volunteers will receive single doses of the 3 rifampicin containing products with a washout of 14 days between doses. Each volunteer will be randomised to receive the 3 doses in one of 6 sequences

Treatment:

Drug: Rimactazid 150/75

Drug: Rifafour e-275

Drug: Rimactane