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Pharmacokinetic Interaction Study in Indonesian Tuberculosis Patients Indonesia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00306319
First Posted: March 23, 2006
Last Update Posted: May 21, 2008
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.
Information provided by:
Radboud University
  Purpose
Pharmacokinetic study in TB patients to determine the effect of rifampicin on the pharmacokinetic profile of moxifloxacin.

Condition Intervention Phase
Tuberculosis Drug: moxifloxacin Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Interaction Study of Rifampicin, Isoniazid and Moxifloxacin in Tuberculosis Patients in Bandung, Indonesia

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Pharmacokinetic (24 hrs) curves will be drawn
  • at day 5 in period I and period II.

Estimated Enrollment: 23
Study Start Date: January 2006
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00306319


Locations
Indonesia
Rumah Sakit Hasan Sadikin (RSHS)
Bandung, Indonesia
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: R. Aarnoutse, PharmD PhD Radboud University (RUNMC)
  More Information

ClinicalTrials.gov Identifier: NCT00306319     History of Changes
Other Study ID Numbers: UMCN-AKF 05.02
Primo study
First Submitted: March 22, 2006
First Posted: March 23, 2006
Last Update Posted: May 21, 2008
Last Verified: May 2008

Keywords provided by Radboud University:
Tuberculosis

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs