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. 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
16
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)
Taipei Medical University- Wan Fang Hospital
Taipei, Taiwan
RECRUITINGThe maximum concentration (Cmax)of first-line TB drugs
Time frame: Before and 1, 2, 4, 6 and 10 hours after dosing
N-acetyltransferase 1 and 2 (NAT 1 and 2), which effects the metabolism of anti-TB drugs, would be examined.
Time frame: Before taking the anti-TB drugs on the fifth day
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