A Phase 1 interventional study of Rimactane and Rifafour e-275 in Tuberculosis, sponsored by University of Cape Town. Completed at 1 site in South Africa. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-10.
Sponsored by University of Cape Town · Phase 1, Interventional, and Other
3-way cross-over single dose design evaluating bioavailability of 2 rifampicin-containing FDCs vs a single drug comparator in healthy volunteers
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
1,435 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's enrollment of 21 is below the median of 150 across 963 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →University of Cape Town is the lead sponsor of 116 studies on the registry; 14 are open to participants now.
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Exclusion
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
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
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
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
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
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
150 mg capsules, Sandoz MCC registration # A/20.2.3/784
Also known as: Rifampicin
Drug pages: Isoniazid · Rifampin · Pyrazinamide · Ethambutol
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.
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
Cmax
Time frame: 1 year
AUC to 12 h
Time frame: 1 year
AUC to infinity
Time frame: 1 year
Plan to share: Yes
No publications or documents are linked to this record.
Ran from Nov 2016 to primary completion in Feb 2017, 3 months.
Of 46 non-industry phase 1 interventional studies under Tuberculosis, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 30. This study's 3 months is below that.
Counting every sponsor, half of 64 studies reached it within 13 months; a quarter within 3 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rifampin