Status:
COMPLETED
Pharmacokinetic Interaction Study in Indonesian Tuberculosis Patients Indonesia
Lead Sponsor:
Radboud University Medical Center
Conditions:
Tuberculosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
Pharmacokinetic study in TB patients to determine the effect of rifampicin on the pharmacokinetic profile of moxifloxacin.
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00306319
Start Date
January 1 2006
End Date
May 1 2006
Last Update
November 12 2020
Active Locations (1)
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1
Rumah Sakit Hasan Sadikin (RSHS)
Bandung, Indonesia