Status:
UNKNOWN
Pharmacokinetic Study for Anti-tuberculosis Drugs
Lead Sponsor:
Taipei Medical University WanFang Hospital
Conditions:
Pulmonary Tuberculosis
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the effect of food on pharmacokinetic profile of multiple doses orally administered first-line anti-tuberculosis drugs in subjects with pulmonary tuberculosis.
Detailed Description
This is a single-center, open-label, randomized, two way crossover design, pharmacokinetics study. 1. Treatment A: study agents (Rifater+EMB) will be given approximately 45 minutes prior to breakfast...
Eligibility Criteria
Inclusion
- Age greater than 20 years
- Karnofsky score of \> 50
- Clinical and radiographic signs and symptoms consistent with pulmonary TB determined by the investigator.
- A documented positive microbiology diagnosis results which indicate highly suspected pulmonary tuberculosis.
- Anti-TB drugs treatment with of ethambutol, isoniazid, rifampin and pyrazinamide.
- Willing to be hospitalized per standard of care for at least 6 days from first does of anti-TB drugs administered.
- Start anti-TB chemotherapy for at least 2 days prior to participate in the study.
- The subject is able to understand and comply with protocol requirements, and follow the instructions and protocol-stated restrictions.
- Only subjects who have provided signed and dated written informed consent will be included.
Exclusion
- Previously treated for MDR-TB, XDR-TB or likely to require surgical procedure for management of TB
- Alcohol or drug abuse that would interfere with the ability to meet study requirements (in the opinion of investigator)
- Concomitant disorders or conditions for which ethambutol, isoniazid, rifampin or pyrazinamide are contraindicated.
- Unable to meet selected safety criteria obtained at screening (Laboratory parameters, etc.)
- Women who are Pregnant or breastfeeding during the study period.
- Subjects with a known allergy to study drugs
- In the opinion of the investigator to be unsuitable for study participation for any reason.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00948077
Start Date
July 1 2009
End Date
December 1 2011
Last Update
April 12 2011
Active Locations (1)
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1
Taipei Medical University- Wan Fang Hospital
Taipei, Taiwan, 116