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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT02265302
Eligibility Criteria:
Inclusion Criteria:
* Healthy male subjects as determined by results of screening
* Age ≥ 21 and ≤ 50 years
* Broca ≥ - 20% and ≤ + 20%
* Signed written informed consent in accordance with Good Clinical Practice and local legislation
Exclusion Criteria:
* Results of the medical examination or laboratory tests that are judged by the clinical investigator to differ significantly from normal clinical values
* Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
* Known history of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of a drug with a long half-life (≥ 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study
* Intake of any other drugs which might influence the results of the trial during the week previous to the start of the study
* Participation in another study with an investigational drug within the last two months preceding this study
* Smokers (\> 5 cigarettes or 2 cigars or 2 pipes/day)
* Volunteer who is not able to refrain from smoking on study days
* Alcohol abuse (more than 60 g of alcohol per day)
* Drug abuse
* Excessive physical activities (e.g. competitive sports) within the last week before the study
* Blood donation within the last 4 weeks (≥ 100 ml)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
21 Years
Maximum Age:
50 Years
Study:
NCT02265302
Study Brief:
Protocol Section:
NCT02265302