Pharmacokinetic Study for Anti-tuberculosis Drugs

Not Applicable

• Conditions: Pulmonary Tuberculosis
• Interventions: Drug: Rifater and EMB

• Registration Number: NCT00948077
• Lead Sponsor: Taipei Medical University WanFang Hospital

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.

2. Treatment B: study agents (Rifater+EMB) will be given approximately 45 minutes after the breakfast is finished.

Study Timeline

• Study First Submitted: 2009-06-16
• Study Start: 2009-07
• Study First Submitted QC: 2009-07-28
• Study First Posted: 2009-07-29
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-11
• Last Update Posted: 2011-04-12
• Primary Completion: 2011-06
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. Age greater than 20 years
2. Karnofsky score of > 50
3. Clinical and radiographic signs and symptoms consistent with pulmonary TB determined by the investigator.
4. A documented positive microbiology diagnosis results which indicate highly suspected pulmonary tuberculosis.
5. Anti-TB drugs treatment with of ethambutol, isoniazid, rifampin and pyrazinamide.
6. Willing to be hospitalized per standard of care for at least 6 days from first does of anti-TB drugs administered.
7. Start anti-TB chemotherapy for at least 2 days prior to participate in the study.
8. The subject is able to understand and comply with protocol requirements, and follow the instructions and protocol-stated restrictions.
9. Only subjects who have provided signed and dated written informed consent will be included.

Exclusion Criteria

1. Previously treated for MDR-TB, XDR-TB or likely to require surgical procedure for management of TB
2. Alcohol or drug abuse that would interfere with the ability to meet study requirements (in the opinion of investigator)
3. Concomitant disorders or conditions for which ethambutol, isoniazid, rifampin or pyrazinamide are contraindicated.
4. Unable to meet selected safety criteria obtained at screening (Laboratory parameters, etc.)
5. Women who are Pregnant or breastfeeding during the study period.
6. Subjects with a known allergy to study drugs
7. In the opinion of the investigator to be unsuitable for study participation for any reason.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment B	Rifater and EMB	Study agents (Rifater+EMB) will be given approximately 45 minutes "after the breakfast is finished."
Treatment A	Rifater and EMB	Study agents (Rifater+EMB) will be given approximately 45 minutes "prior to the breakfast."

Primary Outcome Measures

Name	Time	Method
The maximum concentration (Cmax)of first-line TB drugs	Before and 1, 2, 4, 6 and 10 hours after dosing

Secondary Outcome Measures

Name	Time	Method
N-acetyltransferase 1 and 2 (NAT 1 and 2), which effects the metabolism of anti-TB drugs, would be examined.	Before taking the anti-TB drugs on the fifth day

Trial Locations

Locations (1)

Taipei Medical University- Wan Fang Hospital; 🇨🇳 Taipei, Taiwan