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 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT03054402
Eligibility Criteria:
Inclusion Criteria:
* Healthy male subject
* Age: 18 to 50 years (inclusive) at the first screening visit
* Body mass index (BMI) : 18.5 ≤ BMI ≤ 30 kg/m²
Exclusion Criteria:
* Clinically relevant findings in the physical examination
* Relevant diseases within the last 4 weeks prior to the first study drug administration
* Incompletely cured 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
* Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them within 4 weeks before first study drug administration
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03054402
Study Brief:
Protocol Section:
NCT03054402