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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT03252002
Eligibility Criteria:
Inclusion Criteria:
* The informed consent must be signed before any study specific tests or procedures are done.
* Healthy male subject.
* Age: 18 to 45 years (inclusive) at the screening.
* Body mass index (BMI): above/equal 18 and below/equal 29.9 kg/m2.
* Ability to understand and follow study-related instructions.
Exclusion Criteria:
* Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.
* Subjects with thyroid disorders as evidenced by assessment of thyroid stimulating hormone (TSH) levels outside the normal reference range at screening.
* Regular use of medicines.
* Smoking more than 10 cigarettes daily.
* Systolic blood pressure below 100 or above 145 mmHg (at screening).
* Diastolic blood pressure below 50 or above 90 mmHg (at screening).
* Heart rate below 50 or above 90 beats/ min (at screening).
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03252002
Study Brief:
Protocol Section:
NCT03252002