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

Primary Purpose

Tuberculosis

Status
Completed
Phase
Phase 1
Locations
South Africa
Study Type
Interventional
Intervention
Rimactane
Rifafour e-275
Rimactazid 150/75
Sponsored by
University of Cape Town
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tuberculosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Other

Other

Other

Other

Other

Other

Arm Label

sequence 1

sequence 2

sequence 3

sequence 4

sequence 5

sequence 6

Arm 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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Cmax

Secondary Outcome Measures

Full Information

First Posted
September 5, 2016
Last Updated
May 9, 2017
Sponsor
University of Cape Town
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1. Study Identification

Unique Protocol Identification Number
NCT02953847
Brief Title
The Bioavailability of Rifampicin in (FDCs) Widely Used in South Africa to Treat Drug-susceptible (TB)
Acronym
BIO3FDC
Official Title
The Bioavailability of Rifampicin in Fixed Dose Combinations (FDCs) Widely Used in South Africa to Treat Drug-susceptible Tuberculosis (TB)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cape Town

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sequence 1
Arm Type
Other
Arm 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
Arm Title
sequence 2
Arm Type
Other
Arm 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
Arm Title
sequence 3
Arm Type
Other
Arm 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
Arm Title
sequence 4
Arm Type
Other
Arm 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
Arm Title
sequence 5
Arm Type
Other
Arm 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
Arm Title
sequence 6
Arm Type
Other
Arm 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
Intervention Type
Drug
Intervention Name(s)
Rimactane
Other Intervention Name(s)
Rifampicin
Intervention Description
150 mg capsules, Sandoz MCC registration # A/20.2.3/784
Intervention Type
Drug
Intervention Name(s)
Rifafour e-275
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Rimactazid 150/75
Other Intervention Name(s)
Rifampicin / Isoniazid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cmax
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
AUC to 12 h
Time Frame
1 year
Title
AUC to infinity
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen M McIlleron, PhD
Organizational Affiliation
University of Cape Town
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Centre
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7725
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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