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 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT03734302
Eligibility Criteria:
Inclusion Criteria:
* 1\. Sign the informed consent form
* 2\. At the age of 18\~45 years old (including upper and lower limits).
* 3\. Body weight of not less than 45 kg, body mass index 19 \~ 25kg/m2 range (including the upper and lower limits) \[ body mass index (BMI) = body weight (kg) / height2 (m2)\].
Exclusion Criteria:
* 1\. Participated in any drug test within 12 weeks prior to enrollment.
* 2\. Drug abuse in the past 2 years or a history of substance abuse.
* 3\. Drinking alcohol more than 2 unit per day (1 unit= 360 ml beer , or 45 ml 4.0% alcohol, or 150 ml liquor, or 50 ml wine ) 6 months before the screening, or subjects can not stop drinking during the hospitalization.
* 4\. Drug abuse urine test at screening is positive.
Other protocol-defined inclusion and exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03734302
Study Brief:
Protocol Section:
NCT03734302