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:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT01687920
Eligibility Criteria:
Inclusion Criteria:
* Healthy male subject
* Age: 18 to 46 years (inclusive) at the first screening examination
* Ethnicity: White
* Body mass index (BMI): \>= 18 and \<= 29.9 kg / m²
Exclusion Criteria:
* Clinically relevant findings in the ECG (electrocardiogram) such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec
* Systolic blood pressure below 100 or above 140 mmHg
* Diastolic blood pressure below 50 or above 90 mmHg
* Heart rate below 50 or above 95 beats/ min
* Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2)
* Participation in another clinical study during the preceding 3 months (Last Treatment from previous study to First Treatment of new study)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
46 Years
Study:
NCT01687920
Study Brief:
Protocol Section:
NCT01687920