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 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT01099566
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent obtained before any trial-related activities.
* Men aged \>18 and \<41 years
* Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
Exclusion Criteria:
* Known or suspected allergy to trial product or related products (Prasugrel, Clopidogrel, Ticlopidine)
* Known or suspected hereditary problems of galactose intolerance, Lapp lactase deficiency or glucosegalactose malabsorption
* Treatment with an investigational drug within three weeks prior to this trial
* Treatment with a drug (e.g. ketoconazole, omeprazole) that interferes with cytochrome P450, the enzyme responsible for the conversion of prasugrel to its active form, three weeks prior to this trial
* Participation in an LPS trial within the last 6 weeks
* Smoking of more than 5 cigarettes per day
* Hereditary deficiency of protein C or S, or a mutation of FV (Leiden), or any other known abnormality affecting coagulation, fibrinolysis or platelet function
* History of gastro-duodenal ulcera, cardiovascular disease, vasculitis, diabetes mellitus, or hypertension
* History of brain tumor or history of neurosurgery
* Hemorrhagic diathesis, trauma or surgery within last 3 months
* History of hemorrhagic retinopathy
* Hematuria or detection of occult blood in stool sample
* Liver or kidney dysfunction
* Regular use of medication or abuse of alcohol
* Use of any medication within one week prior to the first trial day
* Symptoms of a clinically relevant illness in the 3 weeks before the first trial day
* Excessive sporting activities
* Weight \>95kg and \<60kg
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
19 Years
Maximum Age:
40 Years
Study:
NCT01099566
Study Brief:
Protocol Section:
NCT01099566