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

NCT02953847 | Completed Phase 1

• 1 other identifier: BIO3FDC
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Cmax

  1 year

Other Outcomes (2)

• AUC to 12 h

  1 year

• AUC to infinity

  1 year

Study Arms (6)

sequence 1

OTHER

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

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

sequence 2

OTHER

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

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

sequence 3

OTHER

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

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

sequence 4

OTHER

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

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

sequence 5

OTHER

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

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

sequence 6

OTHER

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

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

Interventions

Rimactane DRUG

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

Also known as: Rifampicin

sequence 1; sequence 2; sequence 3; sequence 4; sequence 5; sequence 6

Rifafour e-275 DRUG

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.

sequence 1; sequence 2; sequence 3; sequence 4; sequence 5; sequence 6

Rimactazid 150/75 DRUG

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.

Also known as: Rifampicin / Isoniazid

sequence 1; sequence 2; sequence 3; sequence 4; sequence 5; sequence 6

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cape Town: lead

Study Sites (1)

Clinical Research Centre

Cape Town, Western Cape, 7725, South Africa

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

Rifampin; Isoniazid

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Helen M McIlleron, PhD

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Officer

Study Record Dates

• First Submitted: September 5, 2016
• First Posted: November 3, 2016
• Study Start: November 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: May 10, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

ZA (1)