Pharmacokinetic Study for Anti-tuberculosis Drugs (TBPK)

Taipei Medical University

Status: Unknown

Conditions: Pulmonary Tuberculosis

Treatments: Drug: Rifater and EMB

Study type: Interventional

Funder types: Other

Identifiers

NCT00948077

98040

2009WFCRC-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

16 participants in 2 patient groups

Treatment A

Active Comparator group

Description:

Study agents (Rifater+EMB) will be given approximately 45 minutes "prior to the breakfast."

Treatment:

Drug: Rifater and EMB

Treatment B

Experimental group

Description:

Study agents (Rifater+EMB) will be given approximately 45 minutes "after the breakfast is finished."

Treatment:

Drug: Rifater and EMB