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 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
NCT ID:
NCT01995006
Eligibility Criteria:
Inclusion Criteria:
* Healthy male subjects aged between 18 and 45 years (inclusive) at screening
* BMI between 18 and 28 kg/m2 (inclusive) and body weight at least 50 kg at screening.
* systolic blood pressure (SBP): 100-140 mmHg, diastolic blood pressure (DBP): 60-90 mmHg and heart rate (HR): 45-90 bpm (inclusive), measured on the leading arm\*, in the supine position at screening.
* No clinically significant findings on the physical examination at screening.
* 12-lead ECG without clinically relevant abnormalities at screening.
* Signed informed consent prior to any study-mandated procedure.
* Hematology and clinical chemistry results not deviating from the normal range to a clinically relevant extent at screening.
* Ability to communicate well with the investigator and to understand and comply with the requirements of the study.
* leading arm right = writing with right hand
Exclusion Criteria:
* Smoking \> 5 cigarettes per day.
* History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
* Loss of ≥ 250 ml of blood within 3 months prior to screening.
* Treatment with an investigational drug within 30 days prior to screening.
* Previous treatment with any prescribed or over-the-counter (OTC) medication (including herbal medicines such as St John's Wort) within 2 weeks prior to the intended start of the study.
* Legal incapacity or limited legal capacity at screening.
* Positive results from urine drug screen at screening.
* History or clinical evidence of any disease (e.g. GIT-disease: Morbus Crohn, Colitis Ulcerosa, anamnestic gastrointestinal bleeding) and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drugs, or which might increase the risk for toxicity.
* Known hypersensitivity to Aspirin or other NSAIDs or any excipients of the drug formulations.
* Known food allergy, which make the adherence to the diet impossible
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01995006
Study Brief:
Protocol Section:
NCT01995006