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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT02177305
Eligibility Criteria:
Inclusion Criteria:
* Healthy males
* Age range from 21 to 50 years
* Within ± 20% of normal weight (Broca-Index)
* Written informed consent given
Exclusion Criteria:
* Results of the medical examinations or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
* Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Volunteers with disease of the central nervous system (such as epilepsy) or with psychiatric disorders
* Volunteers with known history of orthostatic hypotension, fainting spells or blackouts
* Volunteers with chronic or relevant acute infections
* Volunteers with history of allergy/ hypersensitivity (including drug allergy)
* Volunteers with known eye diseases (incl. glaucoma), with hyperopia (\> 3 diopters) or with contact lenses
* Volunteers with intraocular pressure \> 22 mmHg
* Volunteers with predisposition to narrow-angle glaucoma
* Volunteers with disturbed micturition
* Volunteers who have taken a drug with a long half-life (≥ 24 hours) within ten half-lives of the respective drug before enrolment in the study
* Volunteers who received any other drugs which might influence the results of the trial during the week previous the start of the study
* Volunteers who have participated in another study with an investigational drug within the last two months preceding this study
* Volunteers who smoke (\> 10 cigarettes or 3 cigars or 3 pipes/day)
* Volunteers who are not able to refrain from smoking on study day
* Volunteers who drink more than 40 g of alcohol per day
* Volunteers who are dependent on drugs
* Volunteers who have donated blood (≥ 100 ml) within the last four weeks
* Volunteers who participated in excessive physical activities (e.g. competitive sports) within the last week before the study
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
21 Years
Maximum Age:
50 Years
Study:
NCT02177305
Study Brief:
Protocol Section:
NCT02177305