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 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
NCT01415466
Eligibility Criteria:
Inclusion Criteria:
1. Healthy adult male volunteers aged 20 to 50 years
2. A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
Exclusion Criteria:
1. A subject who had any allergic history to any drug.
2. A subject with sign or symptoms or previously diagnosed disease of liver, kidney, neurology, respiratory, endocrinology, hematology, cardiovascular, genitourinary, psychology, ophthalmic, dermatology and gastrointestinal function or other significant diseases
3. History or suspicion of current drug abuse
4. A subject who had received treatment with below listed drug within specified period prior to the first dose of study medication
* Within 1 month: drug known CYP inducer or inhibitor
* Within 2 weeks: Prescribed or herbal medicine
* Within 1 weeks: OTC medicine
* Within 2 days: Consumption of caffeine
5. A subject who had participated in any other clinical study within the last 2 weeks
6. A subject from whom over 400mL of blood was sampled(whole blood donation) within last 2 weeks or plasma/platelet donation within 1 month.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT01415466
Study Brief:
Protocol Section:
NCT01415466