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 @ 3:59 PM
Ignite Modification Date:
2025-12-24 @ 3:59 PM
NCT ID:
NCT02273492
Eligibility Criteria:
Inclusion Criteria:
* Healthy subjects as determined by results of screening
* Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
* Age ≥ 18 and ≤ 55 years
* Broca ≥ - 20 % and ≤ + 20 %
Exclusion Criteria:
* Any findings 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
* Surgery of the gastro-intestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Chronic or relevant acute infections
* History of hypersensitivity to Asasantin ER and any of the excipients
* 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 administration or during the trial)
* Participation in another trial with an investigational drug (\< 1 month prior to administration or during the trial)
* Known alcohol abuse
* Known drug abuse
* Blood donation (\< 1 month prior to administration)
* Excessive physical activities (\< 5 days prior to administration)
* History of hemorrhagic diatheses
* History of gastro-intestinal ulcer, perforating or bleeding
* History of bronchial asthma
* Any laboratory value outside the normal range of clinical relevance
Female subjects:
* Pregnancy
* Positive pregnancy test
* No adequate contraception (adequate contraception e.g. sterilization, intrauterine devices (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:
55 Years
Study:
NCT02273492
Study Brief:
Protocol Section:
NCT02273492