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 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
NCT ID:
NCT01073059
Eligibility Criteria:
Inclusion Criteria:
* Subjects who are healthy volunteers, men 19\~50 years
* Subjects who have a weight more then 50kg and a condition ± 20% range of ideal weight
Exclusion Criteria:
* Subjects with evidence of clinically significant hepatic, pancreatic, renal, neurological, pulmonary, endocrine, blood tumor, psychiatric or cardiovascular disease
* Subjects who have a GI disease (crohn's disease, etc.) that would increase the influence with absorbance medication or a GI surgery excluding appendectomy and hernia surgery
* Subjects with uncontrolled hypotension (indicated by a sitting systolic blood pressure≤ 100 mmHg or diastolic blood pressure≤ 65 mmHg measured) and hypertension (indicated by a sitting systolic blood pressure≥ 150 mmHg or diastolic blood pressure≥ 95 mmHg measured) at vital sign measurement
* Subjects with known allergy, hypersensitivity (anaphylaxis-type reaction; especially penicillin antibiotics)
* Subjects with a history of drug abuse
* Subjects who received certain medication (include oriental medicine) within the past 3 weeks or certain OTC-drug within 1 week
* Subjects who participated in other clinical investigation within 2months prior to first administration Subjects who did whole blood donation (within 2months) or apheresis (within 1months) prior to first administration
* Subjects who are chronic drinkers
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
19 Years
Maximum Age:
50 Years
Study:
NCT01073059
Study Brief:
Protocol Section:
NCT01073059