Clinical trial NCT00948077: Pharmacokinetic Study for Anti-tuberculosis Drugs
Official title: A Single-Center, Open-Label, Randomized, Crossover Design Study to Evaluate the Effect of Dietary Status on Pharmacokinetic Profile of Orally Administered First-Line Anti-TB Drugs in Subjects With Pulmonary Tuberculosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Tuberculosis
Keywords: tuberculosis
pharmacokinetic
first-line drugs
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2009-07-29
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The maximum concentration (Cmax)of first-line TB drugs
timeFrame: Before and 1, 2, 4, 6 and 10 hours after dosing
Secondary outcomes:
measure: N-acetyltransferase 1 and 2 (NAT 1 and 2), which effects the metabolism of anti-TB drugs, would be examined.
timeFrame: Before taking the anti-TB drugs on the fifth day
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University- Wan Fang Hospital
Study officials:
affiliation: Taipei Medical University- Wan Fang Hospital
name: Ming-Chih MC Yu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: