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 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT02183103
Eligibility Criteria:
Inclusion Criteria:
* Healthy subjects as determined by results of screening
* Written informed consent according good clinical practice (GCP) and local legislation
* Age \>=18 and \<=50 years
* Broca \>= -20% and \<= +20%
Exclusion Criteria:
* Any finding of the medical examination (blood pressure, pulse rate and electrocardiogram (ECG)) deviating from the normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder
* Surgery of gastro-intestinal tract (except appendectomy)
* Disease of central nervous system (such as epilepsy) or psychiatric disorders or neurological disorder
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life ( \>24h) (\<=1month prior to administration)
* Use of any drugs which might influence the results of the trial (\<=10 days prior to administration or during the trial)
* Participation in another trial with an investigational drug (\<= 2 months prior to administration or during the trial)
* Smokers ( \>10 cigarettes or \>3 cigars or \>3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\>60g/day)
* Drug abuse
* Blood donation (\<= 1 month prior to administration or during the trial)
* Excessive physical activities (\<= 5 days prior to administration or during the trial)
* Any laboratory value outside the reference range of clinical relevance
* History of hemorrhagic diatheses
* History of gastro-intestinal ulcer, perforation or bleeding
* History of bronchial asthma
For female:
* Pregnancy
* Positive pregnancy test
* No adequate contraception e.g. sterilization, intrauterine device (IUD), oral contraceptives
* Inability to maintain this adequate contraception during the whole study period
* Lactation period
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02183103
Study Brief:
Protocol Section:
NCT02183103