TBTC Study 25PK: Intensive Pharmacokinetic Study of Three Doses of Rifapentine and 25-Desacetyl Rifapentine
NCT00023387 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2005-09-13
Summary
Primary objective: To compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three different doses: 600 mg, 900 mg, and 1200 mg.
Secondary objective: To describe any correlation between pharmacokinetic parameters of three different doses of rifapentine plus a standard dose of isoniazid and the occurrence of toxicity attributed to anti-tuberculosis treatment.
Conditions
Interventions
- DRUG
-
Rifapentine
- DRUG
-
25-desacetyl Rifapentine
- DRUG
-
Isoniazid
Sponsors & Collaborators
-
US Department of Veterans Affairs
collaborator FED -
Centers for Disease Control and Prevention
lead FED
Principal Investigators
-
Marc Weiner, MD · Audie L. Murphy VA Medical Center, San Antonio TX
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2000-03-31
- Completion
- 2001-05-31
Countries
- United States
- Canada
Study Locations
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