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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT02259894
Eligibility Criteria:
Inclusion Criteria:
* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
* Age \>=18 and \<=50 years
* BMI \>=18.5 and \<=29.9 kg/m2
Exclusion Criteria:
* Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, haematological, oncological or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* Relevant 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 drugs with a long half-life (\> 24 hours) (\< 1 month prior to administration or during the trial)
* Use of any drugs, which might influence the results of the trial, (\< 10 days prior to study drug administration or expected during the trial)
* Participation in another trial with an investigational drug (\< 2 months prior to administration or expected during trial)
* Smoker (\> 10 cigarettes or \>3 cigars or \>3 pipes/day)
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation or loss \> 400 mL, \< 1 month prior to administration or expected during the trial
* Clinically relevant laboratory abnormalities
* Any ECG value outside of the reference range and of clinical relevance including, but not limited to QRS interval \> 110 ms or QT interval, Bazett correction (QTcB) \> 450 ms or QT interval \>500 ms
* Inability to comply with dietary regimen of study centre
* Inability to comply with investigator's instructions
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02259894
Study Brief:
Protocol Section:
NCT02259894