Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT01785927
Eligibility Criteria:
Inclusion Criteria:
* Aged 18-45 years
* Body mass index 18-27 kg/m2
* Healthy
* In the case of reproductive age woman, effective contraceptive will be used for at least 4 weeks prior to a screening examination until the end of study.
* Non-lactating women
* Patients who are willing to participate in the trial and will first sign the informed consent form.
Exclusion Criteria:
* Allergic to any antituberculosis drugs or other components
* High blood pressure (diastolic pressure \> 90 mmHg)
* Liver enzymes (AST and ALT) \> 2 times of upper normal value
* Pregnancy or lactation
* No underlying diseases such as asthma, COPD, chronic kidney disease, diabetes mellitus, liver disease, immunocompromised deficiency, etc.
* HBsAg positive
* Abnormality in chest X-ray or routine laboratory tests
* Smokers \> 10 cigarette/day or smokers \< 10 cigarettes/day who could not quit at least 7 days before study and throughout study (including the washout between periods)
* Regular alcohol consumption (more than 1 time/week) or alcohol consumption within 7 days prior to the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01785927
Study Brief:
Protocol Section:
NCT01785927