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

Tuberculosis Clinical Trial

— BIO3FDC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02953847
• Other study ID #: BIO3FDC
• Status: Completed
• Phase: Phase 1
• First received: September 5, 2016
• Last updated: May 9, 2017
• Start date: November 2016
• Est. completion date: February 2017

Study information

• Verified date: May 2017
• Source: University of Cape Town
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Drug:
• Rimactane
150 mg capsules, Sandoz MCC registration # A/20.2.3/784
• 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.
• 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.

Locations

Country	Name	City	State
South Africa	Clinical Research Centre	Cape Town	Western Cape

Sponsors (1)

Lead Sponsor	Collaborator
University of Cape Town

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	AUC to 12 h		1 year
Other	AUC to infinity		1 year
Primary	Cmax		1 year