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 @ 1:32 PM
Ignite Modification Date:
2025-12-24 @ 1:32 PM
NCT ID:
NCT01383395
Eligibility Criteria:
Inclusion Criteria:
* Healthy male subjects aged 20 - 48 years
* A body mass index (BMI) in the range 19-27 kg/m2
* Provide written informed consent after being fully informed about the study procedures
* Subject without any congenital or chronic disease and with no pathologic symptom in the physical examination
* Determined eligible in the ECG, clinical laboratory tests and urinalysis
Exclusion Criteria:
* Use of medication which induces or inhibits drug metabolizing enzyme (CYP3A4 etc.) within 30 days prior to drug dosing
* Use of medication within 10 days before first dose
* Abnormal diet that can influence on tlhe ADME of drugs (grapefruit juice etc.)
* Presence or history of clinically significant allergic disease, alcohol abuse, drug hypersensitivity
* Whole blood donation during 60 days before the study
* Participation in other clinical trial within 90 days prior to scheduled study drug administration
* Subject judged not eligible for study participation by investigator
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
48 Years
Study:
NCT01383395
Study Brief:
Protocol Section:
NCT01383395