Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 98040 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This is a single-center, open-label, randomized, two way crossover design, pharmacokinetics study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Active Comparator | Study agents (Rifater+EMB) will be given approximately 45 minutes "prior to the breakfast." |
|
| Treatment B | Experimental | Study agents (Rifater+EMB) will be given approximately 45 minutes "after the breakfast is finished." |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifater and EMB | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| The maximum concentration (Cmax)of first-line TB drugs | Before and 1, 2, 4, 6 and 10 hours after dosing |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming-Chih MC Yu, M.D. | Contact | +886-2-29307930 | 52953 | yutbc@ms10.hinet.net |
| Name | Affiliation | Role |
|---|---|---|
| Ming-Chih MC Yu, M.D. | Taipei Medical University- Wan Fang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University- Wan Fang Hospital | Recruiting | Taipei | 116 | Taiwan |
Not provided
| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C087181 | isoniazid, pyrazinamide, rifampin drug combination |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |