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 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT01870466
Eligibility Criteria:
Inclusion Criteria:
* Healthy male subjects aged 20 - 55 years
* A body mass index in the range 18.5 - 27 kg/m2
* Willingness to participate during the entire study period
* Written informed consent after being fully informed about the study procedures
Exclusion Criteria:
* Any past medical history of hepatic, renal, neurologic, cardiovascular, respiratory, endocrine, hemato-oncologic or psychiatric disease
* Active bleeding or bleeding tendency
* History of gastrointestinal disease or surgery possibly affecting drug absorption
* History of clinically significant drug hypersensitivity
* Use of medication within 7 days before the first dose
* Heavy drinker (\>140 g/week)
* Whole blood donation during 60 days before the study
* Judged not eligible for study participation by investigator
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
55 Years
Study:
NCT01870466
Study Brief:
Protocol Section:
NCT01870466