Pharmacokinetic Interaction Study in Indonesian Tuberculosis Patients Indonesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00306319
Recruitment Status : Completed
First Posted : March 23, 2006
Last Update Posted : May 21, 2008
Information provided by:
Radboud University

March 22, 2006
March 23, 2006
May 21, 2008
January 2006
May 2006   (Final data collection date for primary outcome measure)
  • Pharmacokinetic (24 hrs) curves will be drawn
  • at day 5 in period I and period II.
Same as current
Complete list of historical versions of study NCT00306319 on Archive Site
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Pharmacokinetic Interaction Study in Indonesian Tuberculosis Patients Indonesia
Pharmacokinetic Interaction Study of Rifampicin, Isoniazid and Moxifloxacin in Tuberculosis Patients in Bandung, Indonesia
Pharmacokinetic study in TB patients to determine the effect of rifampicin on the pharmacokinetic profile of moxifloxacin.
Tuberculosis is an infectious disease that still causes many victims in the developing world, especially in Indonesia. Rifampicin, isoniazid and ethambutol are the cornerstone of the current treatment. The disadvantage of the current treatment is the long, six-months, duration of the treatment. This long duration contributes to suboptimal adherence to the TB drugs.Thus, there is a very urgent need to evaluate drugs that may help shortening TB treatment. The fluoroquinolone moxifloxacin has shown early bactericidal activity (EBA) in patients with pulmonary TB, and has shown rapid and reliable sterilization. Rifampicin is a strong inducer of the CYP enzymes, but it also induces phase II metabolism. As moxifloxacin is metabolized by phase II metabolism, rifampicin could cause a decrease in the plasma concentrations of moxifloxacin. Therefore, a pharmacokinetic interaction study is warranted.
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: moxifloxacin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2006
May 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Indonesian AFB negative tuberculosis patients who are in the last two months of the continuation phase of their six-month-antituberculosis treatment.
  • Subject is 18-55 years of age at the day of the first dosing of study medication.
  • Subject has a normal ECG
  • Subjects bodyweight is >35kg
  • Use of rifampicin and isoniazid

Exclusion Criteria:

  • Pregnant or lactating
  • History or condition that might interfere with drug absorption, distribution, metabolism or excretion, including ileus, gastric paresis, liver and renal dysfunction, diabetes mellitus.
  • Presence of contraindications for moxifloxacin or use of drugs that are known to interact with moxifloxacin.
  • Subject is not able and/or not willing to sign the informed consent form.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
UMCN-AKF 05.02
Primo study
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Radboud University
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Principal Investigator: R. Aarnoutse, PharmD PhD Radboud University (RUNMC)
Radboud University
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP