Skip to main content
OpenTrials
Completed

NCT Number: NCT02953847

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Research Centre

Cape Town, Western Cape, 7725, South Africa

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rimactane

Drug

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

Other names: Rifampicin

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.

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.

Other names: Rifampicin / Isoniazid

Primary outcomes

  1. Cmax

    Time frame: 1 year

Other outcomes

  1. AUC to 12 h

    Time frame: 1 year

  2. AUC to infinity

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Cape Town

Other

Registry information

Official study title

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

Acronym: BIO3FDC

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 3, 2016
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.