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 @ 5:18 PM
Ignite Modification Date:
2025-12-26 @ 5:18 PM
NCT ID:
NCT02183506
Eligibility Criteria:
Inclusion Criteria:
* Healthy males according to the following criteria, based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
* No finding deviating from normal and of clinical relevance
* No evidence of a clinically relevant concomitant disease
* Age ≥ 21 and Age ≤ 50 years
* BMI (Body Mass Index) ≥ 18.5 and ≤ 29.9 kg/m2
* Ability to give signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and the local legislation
Exclusion Criteria:
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant 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 by the investigator
* Intake of drugs with a long half-life (\>24 hours) within one month or less than 10 half-lives of the respective drug prior to administration or during the conduct of this trial (review with clinical monitor if there is a question)
* Use of drugs which might reasonably influence the results of the trial (based on knowledge at the time of protocol preparation) within 10 days prior to administration or during the conduct of this trial
* Participation in another trial with an investigational drug within two months prior to administration or during the conduct of this trial
* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
* Inability to refrain from smoking during the conduct of this trial
* Alcohol abuse (more than 60 g/day)
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the conduct of this trial)
* Excessive physical activities (within one week prior to administration or during the conduct of this trial)
* Any laboratory value outside the normal reference range that is of clinical relevance
* Inability to comply with the dietary regimen of the study center
* No adequate contraception (condom use plus another form of contraception e.g., spermicide, oral contraceptive taken by female partner, sterilization) during the whole study period from the time of the first intake of study drug until one month after the last intake of drug
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
21 Years
Maximum Age:
50 Years
Study:
NCT02183506
Study Brief:
Protocol Section:
NCT02183506