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 @ 12:15 PM
Ignite Modification Date:
2025-12-24 @ 12:15 PM
NCT ID:
NCT01975961
Eligibility Criteria:
Inclusion Criteria:
1. Healthy male and female aged 20 to 50 with a body mass index(BMI) between 18.5 and 25 kg/m2
2. Acceptable medical history, physical examination, laboratory tests and EKG, during screening
3. Provision of signed written informed consent 20\~50 yrs old, healthy Korean Subjects
Exclusion Criteria:
1. History of and clinically significant disease
2. Sitting blood pressure meeting the following criteria at screening: 150 ≥ systolic blood pressure ≤100 (mmHg) and 100 ≥ diastolic blood pressure ≤ 65 (mmHg) amd 100 ≥ Heart rate ≤ 40
3. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
4. Administration of other investigational products within 90 days prior to the first dosing.
5. Administration of herbal medicine within 28 days or administration of ethical drugs within 14 days or administration of over-the-counter (OTC) drugs within 7 days prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study).
6. Have AST(SGOT) or/and ALT(SGPT) \> 3 times of normal upper limit at the time of screening
7. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT01975961
Study Brief:
Protocol Section:
NCT01975961