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 @ 4:02 PM
Ignite Modification Date:
2025-12-26 @ 4:02 PM
NCT ID:
NCT02044406
Eligibility Criteria:
Inclusion criteria:
* Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs blood pressure (BP), pulse rate (PR), 12-lead ECG, and clinical laboratory tests
* Age 18 to 50 years (incl.)
* Body mass index (BMI) 18.5 to 29.9 kg/m2 (incl.)
* Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Exclusion criteria:
* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator
* Repeated measurement of systolic blood pressure \< 90 mmHg and \>= 140 mmHg at screening
* Repeated measurement of diastolic blood pressure \< 55 and \>= 90 mmHg at screening
* Repeated measurement of pulse rate \< 50 bpm and \> 90 bpm at screening
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02044406
Study Brief:
Protocol Section:
NCT02044406