Pulmonary Tuberculosis
Conditions
Keywords
tuberculosis, pharmacokinetic, first-line drugs
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.
Interventions
DRUGRifater and EMB
The main difference between Treatment A and Treatment B is the time of taking drugs, so the intervention of this study belongs to a behavioral intervention. The patients assigned randomly the Arm Treatment A on the fifth day will be switched to the Arm Treatment B on the sixth day. On the other hand, the patients assigned randomly the Arm Treatment B on the fifth day will be switched to the Arm Treatment A on the sixth day. The flow of intervention is drawn as below. Treatment A (5th day) ---\> Treatment B (6th day) ; Treatment B (5th day) ---\> Treatment A (6th day)
Sponsors
Taipei Medical University WanFang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The maximum concentration (Cmax)of first-line TB drugs | Before and 1, 2, 4, 6 and 10 hours after dosing |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Taiwan
Contacts
Primary ContactMing-Chih MC Yu, M.D.
Outcome results
None listed