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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT01838967
Eligibility Criteria:
Inclusion Criteria:
1. Healthy male volunteers, age 20 to 40 years
2. The result of Body Mass Index(BMI) is not less than 18.5 kg/m2 , no more than 25 kg/m2 and body weight are least 55 kg
3. Subjects who have no congenital or chronic disease and no abnormal symptom or opinion
4. Acceptable serum test, hematologic test, blood chemistry examination, urin test and ECG, physical examination during screening
5. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
Exclusion Criteria:
1. A subject with clinical evidence or history of hepatic (including carrier of hepatitis virus), renal, respiratory, endocrine, neurologic, immunologic, hematologic, oncologic, psychiatric, or cardiovascular disease
2. A subject with a history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug
3. A subject with history of drug allergies (aspirin, antibiotics, including study drug etc.), or history of clinically significant allergies
4. Systolic blood pressure \<100mmHg or Diastolic blood pressure \< 60 mmHg, systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100mmHg(Sitting blood pressure) during the screening procedure.
5. Presence or history of drug abuse or positive result in urine drug screening test
6. Use any prescriptive medication, Korean traditional medication not considered acceptable by the clinical investigator during the last 14 days period before first dosing, or use any OTC medication not considered acceptable by the clinical investigator during the last 7 days period before first dosing (if used medication is considered acceptable by investigator, patients can be included)
7. Participation in clinical trials of any drug within 60 days prior to the participation of the study
8. Blood donation during 2 months or apheresis during 1 month before the study
9. Use of alcohol over 21 units/weeks
10. Smoker who smoke more than 20 cigarettes per day
11. A subject who takes grapefruit, grapefruit juice, or grapefruit-containing products within 3 days prior to the participation of the study
12. A subject who takes St John's wort or some food including the ingredient within 14 days prior to the participation of the study
13. Judged to be inappropriate for the study by the investigator after reviewing clinical laboratory results or other reasons.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
40 Years
Study:
NCT01838967
Study Brief:
Protocol Section:
NCT01838967