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临床试验/ACTRN12617001643369
ACTRN12617001643369尚未招募1 期

Inhaled rifampicin safety and dose finding proof of concept study in healthy volunteers

niversity of Otago0 个研究点目标入组 50 人开始时间: 2017年12月19日最近更新:
适应症

试验速览

阶段
1 期
状态
尚未招募
入组人数
50

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 55 Years(—)
性别
All

入选标准

  • 1. Provision of signed and dated informed consent form.
  • 2. In good general health as evidenced by medical history, no current prescription medication usage, normal FEV1 (forced expiratory volume in 1 second, ), FVC (forced vital capacity) values, normal baseline liver function test values.
  • 3. Ability to take oral and inhaled medication

排除标准

  • 1. Current use of prescription medications or use in the past one month
  • 2. Pregnancy or lactation.
  • 3. History of asthma, or past respiratory condition and previous known exposure to TB.
  • 4. Abnormalities on pulmonary function tests on screening and abnormalities in baseline liver function tests with ALT, ALP, BILI values > 3x ULN.

研究者

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