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 @ 11:13 AM
Ignite Modification Date:
2025-12-26 @ 11:13 AM
NCT ID:
NCT02269228
Eligibility Criteria:
Inclusion Criteria:
* All participants in the study should be healthy females/males, range from 18 to 55 years of age and be within a Broca Index of ≥ - 20 % and ≤ + 20 %
* Prior to admission to the study all subjects will have given, in accordance with good clinical practice (GCP) and the local legislation, their written informed consent.
Exclusion Criteria:
* Subjects will be excluded from the study if the results of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and are of clinical relevance
* Subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders or neurological disorders
* Subjects with known history of orthostatic hypotension, fainting spells or blackouts
* Subjects with chronic or relevant acute infections
* Subjects with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Subjects who have taken a drug with a long half-life (\> 24 hours) (≤ 1 month prior to administration or during the trial)
* Subjects who received any other drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial)
* Subjects who have participated in another study with an investigational drug (≤ 1 month prior to administration or during the trial)
* Subjects who smoke more than 15 cigarettes or 4 cigars or 4 pipes/day
* Subjects who are not able to refrain from excessive consumption of methylxanthine containing drinks or food
* Subjects who drink more than 60 g of alcohol per day
* Subjects who are dependent on drugs
* Subjects who have donated blood (\> 400 ml) (≤ 4 weeks prior to administration or during the trial)
* Subjects who have participated in excessive physical activities (≤ 5 days prior to administration or during the trial)
For female subjects:
* Pregnancy
* Positive pregnancy test
* No adequate contraception (acceptable: e.g. sterilisation, intrauterine devices (IUD), oral contraceptives, condoms)
* Inability to maintain this adequate contraception during the whole study period
* Lactation period
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02269228
Study Brief:
Protocol Section:
NCT02269228