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 @ 12:19 PM
Ignite Modification Date:
2025-12-26 @ 12:19 PM
NCT ID:
NCT04613700
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 75 years
* Body mass index between 18.5 and 27.5 kg/m2
* Informed consent
* Body weight above 50 kg
Exclusion Criteria:
* Anaemia (blood haemoglobin below normal range)
* Known liver disease and/or alanine aminotransferase and/or aspartate transaminase \> 2 times upper normal values
* Nephropathy (serum creatinine above normal range and/or albuminuria)
* Clinically significant kidney function impairment or other laboratory findings leading to the diagnosis of clinically relevant disorders (thyroid dysfunction, anaemia etc)
* Any physical or psychological condition that the investigators feel would interfere with trial participation
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04613700
Study Brief:
Protocol Section:
NCT04613700