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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT02675660
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, 20-75 years of age on the day of dosing and is generally healthy as determined by medical history, physical examination, and laboratory test values
2. For females, postmenopausal for at least 2 years prior to screening (confirmed by a negative hormone panel, i.e., plasma 17β-estradiol concentration of \<20 pg/mL and follicle-stimulating hormone level of \>40 IU/mL) or contraception
3. Has signed and received a copy of the written informed consent form approved by the investigator's Independent Ethics Committee (IEC), understands the purposes and risks of the study and agrees to follow the restrictions and schedule of procedures as defined by the study protocol
Exclusion Criteria:
1. Sitting blood pressure greater than 160/100 or less than 90/60 mm Hg
2. Sitting heart rate greater than 99 bpm or less than 50 beats per minute (bpm)
3. History of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or light-headedness
4. Body Mass Index (BMI) greater than 32 or less than 16 at screening \[BMI = Weight (kg) ÷ Height2 (m2)\]
5. History or symptoms of cardiovascular disease, particularly coronary artery disease, arrhythmias,or congestive heart failure
6. History of significant central nervous system disease, including transient ischemic attack, stroke, seizure disorder, or behavioral disturbances
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT02675660
Study Brief:
Protocol Section:
NCT02675660