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 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT02182960
Eligibility Criteria:
Inclusion Criteria:
* Healthy males from 21 to 50 years and within +-20% of their normal weight (Broca index)
* Written informed consent
Exclusion Criteria:
* Any findings of the medical examination or laboratory tests deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory (especially bronchial asthma and chronic obstructive pulmonary disease), cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or 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 enrolment in the study
* Use of any drugs which might influence the results of the trial within seven days prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to the start of the study
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
* Inability to refrain from smoking on study days
* Alcohol abuse
* Drug abuse
* Blood donation (\>100 ml) within four weeks prior to administration
* Other disease or abnormality of clinical relevance
* Excessive physical activities within two weeks prior to administration or during the trial
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
21 Years
Maximum Age:
50 Years
Study:
NCT02182960
Study Brief:
Protocol Section:
NCT02182960