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

May 9, 2017 updated by: Helen Margaret McIlleron, University of Cape Town

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7725
        • Clinical Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: sequence 1

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
150 mg capsules, Sandoz MCC registration # A/20.2.3/784
Other Names:
  • Rifampicin
Drug: Rifafour 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.
Drug: Rimactazid 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.
Other Names:
  • Rifampicin / Isoniazid
Other: sequence 2

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
150 mg capsules, Sandoz MCC registration # A/20.2.3/784
Other Names:
  • Rifampicin
Drug: Rifafour 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.
Drug: Rimactazid 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.
Other Names:
  • Rifampicin / Isoniazid
Other: sequence 3

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
150 mg capsules, Sandoz MCC registration # A/20.2.3/784
Other Names:
  • Rifampicin
Drug: Rifafour 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.
Drug: Rimactazid 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.
Other Names:
  • Rifampicin / Isoniazid
Other: sequence 4

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
150 mg capsules, Sandoz MCC registration # A/20.2.3/784
Other Names:
  • Rifampicin
Drug: Rifafour 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.
Drug: Rimactazid 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.
Other Names:
  • Rifampicin / Isoniazid
Other: sequence 5

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
150 mg capsules, Sandoz MCC registration # A/20.2.3/784
Other Names:
  • Rifampicin
Drug: Rifafour 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.
Drug: Rimactazid 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.
Other Names:
  • Rifampicin / Isoniazid
Other: sequence 6

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
150 mg capsules, Sandoz MCC registration # A/20.2.3/784
Other Names:
  • Rifampicin
Drug: Rifafour 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.
Drug: Rimactazid 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.
Other Names:
  • Rifampicin / Isoniazid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax
Time Frame: 1 year
1 year

Other Outcome Measures

Outcome Measure
Time Frame
AUC to 12 h
Time Frame: 1 year
1 year
AUC to infinity
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cape Town

Investigators

  • Principal Investigator: Helen M McIlleron, PhD, University of Cape Town

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

September 5, 2016

First Submitted That Met QC Criteria

November 1, 2016

First Posted (Estimate)

November 3, 2016

Study Record Updates

Last Update Posted (Actual)

May 10, 2017

Last Update Submitted That Met QC Criteria

May 9, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIO3FDC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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