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 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT03444467
Eligibility Criteria:
Inclusion Criteria:
* Male, aged 18 -55 years (both inclusive), at the time of signing informed consent
* Body mass index (BMI) between 18.5 and 28.0 kg/sqm (both inclusive)
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG and clinical laboratory tests performed during the screening visit, as judged by the investigator
Exclusion Criteria:
* Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
* Smoker (defined as a subject who is smoking at least one cigarette or equivalent daily) who is not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
* Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03444467
Study Brief:
Protocol Section:
NCT03444467