NCT00948077Unknown不适用
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- The maximum concentration (Cmax)of first-line TB drugs
研究概览
简要总结
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.
详细描述
This is a single-center, open-label, randomized, two way crossover design, pharmacokinetics study.
- Treatment A: study agents (Rifater+EMB) will be given approximately 45 minutes prior to breakfast.
- Treatment B: study agents (Rifater+EMB) will be given approximately 45 minutes after the breakfast is finished.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 20 years
- •Karnofsky score of > 50
- •Clinical and radiographic signs and symptoms consistent with pulmonary TB determined by the investigator.
- •A documented positive microbiology diagnosis results which indicate highly suspected pulmonary tuberculosis.
- •Anti-TB drugs treatment with of ethambutol, isoniazid, rifampin and pyrazinamide.
- •Willing to be hospitalized per standard of care for at least 6 days from first does of anti-TB drugs administered.
- •Start anti-TB chemotherapy for at least 2 days prior to participate in the study.
- •The subject is able to understand and comply with protocol requirements, and follow the instructions and protocol-stated restrictions.
- •Only subjects who have provided signed and dated written informed consent will be included.
排除标准
- •Previously treated for MDR-TB, XDR-TB or likely to require surgical procedure for management of TB
- •Alcohol or drug abuse that would interfere with the ability to meet study requirements (in the opinion of investigator)
- •Concomitant disorders or conditions for which ethambutol, isoniazid, rifampin or pyrazinamide are contraindicated.
- •Unable to meet selected safety criteria obtained at screening (Laboratory parameters, etc.)
- •Women who are Pregnant or breastfeeding during the study period.
- •Subjects with a known allergy to study drugs
- •In the opinion of the investigator to be unsuitable for study participation for any reason.
研究组 & 干预措施
Treatment A
Active Comparator
Study agents (Rifater+EMB) will be given approximately 45 minutes "prior to the breakfast."
干预措施: Rifater and EMB (Drug)
Treatment B
Experimental
Study agents (Rifater+EMB) will be given approximately 45 minutes "after the breakfast is finished."
干预措施: Rifater and EMB (Drug)
结局指标
主要结局
The maximum concentration (Cmax)of first-line TB drugs
时间窗: Before and 1, 2, 4, 6 and 10 hours after dosing
次要结局
- 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)
研究者
研究点 (1)
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