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:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT02265666
Eligibility Criteria:
Inclusion Criteria:
* All participants are healthy males
* Age range from 21 to 50 years
* Broca-Index: within +- 20% of normal weight
* In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give their written informed consent prior to admission to the study
Exclusion Criteria:
* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
* 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 enrollment in the study
* Use of any drugs which might influence the results of the trial (\<= one week prior to administration or during the trial)
* Participation in another trial with an investigational drug (\<= two months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
* Inability to refrain from smoking on study days
* Alcohol abuse (\> 60g/day)
* Drug abuse
* Blood donation (\>= 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within the last week before the study )
* Any laboratory value outside the reference range of clinical relevance
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
21 Years
Maximum Age:
50 Years
Study:
NCT02265666
Study Brief:
Protocol Section:
NCT02265666