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 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT00954304
Eligibility Criteria:
Inclusion Criteria:
1. Healthy male volunteers aged 20 to 50 years at screening
2. Subjects whose weights are heavier than or equal to 50 kg and ±20% of ideal body weight
* Ideal body weight = (height cm - 100) x 0.9
3. Subjects who provided written, voluntary informed consent to participate in this clinical trial and to comply the directions including contraception after being fully informed of and understand this trial
Exclusion Criteria:
1. Subjects who have the clinically significant diseases or history in liver, kidney, nervous system, respiratory system, endocrine system, blood tumor and cardiovascular system.
2. History of the gastrointestinal diseases which may affect the absorption of oral drugs (e.g., Crohn's disease) or gastrointestinal operations (excluding simple typhlotomy and hernia repair).
3. The following results in laboratory test
* AST, ALT \> 1.25 x upper limits of normal
4. Systolic blood pressure below 100 mmHg or above 150 mmHg or diastolic blood pressure below 65 mmHg or above 95 mmHg in vital signs
5. History of drug allergy or other allergies which are clinically significant
6. History of drug abuse or positive reaction for drug abuse in urine screening test
7. Subjects who took prescription drugs or herbal medicines within 2 weeks prior to the first day of drug administration or OTC or vitamin preparations within 1 week prior to the first day of drug administration If the subjects meet other criteria, they could participate in the trial in the judgement of investigator.)
8. Subjects who have participated in other clinical trial within 2 months prior to the first day of drug administration
9. Whole blood donation within 2 months prior to the first day of drug administration or apheresis donation within 2 weeks prior to the first day of drug administration
10. Subject who are continuously drinking alcohol (over 21 units/week) or who cannot quit drinking during clinical trial period
11. Subject who are smoking over 10 cigar/day
12. Subjects who eat food containing caffeine or grapefruit or drink alcohol in prohibited period
13. Subjects who are inappropriate in the judgement of the investigator due to the reasons including clinical laboratory test results
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT00954304
Study Brief:
Protocol Section:
NCT00954304