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 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT01227603
Eligibility Criteria:
Inclusion Criteria:
* Healthy male subject
* Age: 18 to 45 years (inclusive) at the first screening / examination visit
* Ethnicity: Caucasian
* Body mass index (BMI): \>/=18 and \</=29,9 kg/m²
Exclusion Criteria:
* Systolic blood pressure below 120 or above 145 mmHg
* Diastolic blood pressure above 95 mmHg
* Heart rate below 45 or above 95 beats / min
* Clinically relevant findings in the physical examination
* Suspicion of drug or alcohol abuse
* Regular daily consumption of more than 1 L of xanthin-containing beverages
* Intake of foods or beverages containing grapefruit within 4 weeks before the pre-study examination
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01227603
Study Brief:
Protocol Section:
NCT01227603