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 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT02264002
Eligibility Criteria:
Inclusion Criteria:
* All participants in the study should be healthy males and females. Volunteers will
* be 21 to 55 years of age
* have a Body Mass Index (BMI) of 19.9 to 29.9 kg/m2 and
* have a resting heart rate (HR) (after 10 min. in the supine position) of more than 55 beats per minute (bpm)
* Only post-menopausal females, or those who had had a hysterectomy, could participate. All females had to have a negative pregnancy test
* In accordance with good clinical practice (GCP) and the local legislation all volunteers had to give their written informed consent prior to admission to the study
Exclusion Criteria:
* Any finding of the medical examination (including BP, HR 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 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 as judged by the Investigator
* Intake of drugs with a long half-life (\> 24 hours) within 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 two weeks 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 of \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 g/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
Not necessarily clinically relevant abnormalities, but specific Exclusion criteria for the drugs under study or for the study:
* Consumption of more than 2 cups of coffee or black tea, or cola drinks, per day during the last 6 weeks. However, subjects may participate if abstinence from the before mentioned beverages is well tolerated during an interval of at least 2 weeks between screening and first treatment
* ECG: PQ interval \> 210 ms
* HR at rest \< 55 bpm
* Systolic BP \< 115 mmHg
* Colour vision test abnormal. However, subjects may participate if they are able to perform the flicker fusion test without difficulty
* Psoriasis (own medical history or relative)
* Relevant ophthalmological disease
* History of asthma or obstructive pulmonary disease
* History (including childhood) of traumatic injury to the head or brain
* History (including childhood) of reduced seizure threshold
* The following subjects will not be allowed to participate in the study
* Any subject involved in professional transportation of human subjects
* Any subject involved in operating dangerous machinery
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
55 Years
Study:
NCT02264002
Study Brief:
Protocol Section:
NCT02264002