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:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
NCT ID:
NCT02194335
Eligibility Criteria:
Inclusion Criteria:
* Participants should be healthy males and females
* Age range from 21 to 50 years
* Broca Index: within +- 20% of their normal weight
* Subsequently each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead Electrocardiogram (ECG). Hematopoietic, hepatic and renal function test will be carried out in the laboratory. The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first administration of the test substance. In accordance with Good Clinical Practice (GCP) and local legislation all volunteers will have given their written informed consent prior to admission to the study
Exclusion Criteria:
* Any finding of the medical examination (including blood pressure, pulse rate 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 (such as epilepsy) or with psychiatric disorders or neurological disorders
* 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) within at least one month or less than ten half-lives of the respective drug before enrolment in the study (exclusion: substitution therapy regarding thyroid gland and/or ovaries)
* Use of any drugs which might influence the results of the trial (within one week prior to administration or during the trial)
* Participation in another study with an investigational drug within two months prior to administration or during the trial
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on study 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
For female subjects:
* Pregnancy
* Positive pregnancy test
* No adequate contraception e.g. oral contraceptives, sterilization, intrauterine pessary (IUP)
* Inability to maintain this adequate contraception during the whole study period
* Lactation period
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
50 Years
Study:
NCT02194335
Study Brief:
Protocol Section:
NCT02194335