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:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT03494712
Eligibility Criteria:
Inclusion Criteria:
* Young healthy male subjects aged between 18 and 45 years (both inclusive)
Exclusion Criteria:
* Any acute or chronic illness or clinically relevant findings such as livers,kidney, spleen, cardiovascular disease, eye disease in the selection/ inclusion visit examinations
* Any abnormal laboratory result on blood and urine samples taken during screening, judged clinically relevant by the investigator
* History of liver dysfunction or total bilirubin or ALT or AST or ALP or γGT \> ULN at selection
* History of renal dysfunction or GFR \< 75mL/min/1.73 m2 (MDRD equation) at selection
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03494712
Study Brief:
Protocol Section:
NCT03494712