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 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT02095704
Eligibility Criteria:
Inclusion Criteria:
1. Sex: Male or female (limited to PK study)
2. Healthy volunteers, age: 18-45（medical history, physical examination, vital signs, ECG and lab tests are qualified during screening）
3. Body Mass Index（BMI）:19\~24 or body weight is not less than 50Kg
4. Non-pregnant women confirmed by pregnancy test
5. Vital Signs: after 3 minutes supination, the following measurements criteria should be within ranges: body temperature (axillary temperature), 36.0\~37.0 ℃; blood pressure, SBP 90\~140mmHg（12.0\~18.7kpa）and DBP 60\~90mmHg（8.0\~12.0kpa）; arterial pulse: 60\~100 bpm
6. Non-hypersensitivity to this product or its similar product
7. Non-smoker, non-alcoholic
8. Subject must be able to sign Inform Consent prior to participation into this study
9. Subject must be able to communicate with investigator and comply with study protocol.
Exclusion Criteria:
Subjects meet with one or several of the following criteria should be excluded:
1. Subjects failed in physical examination
2. Pregnant or nursing women
3. Administration of a known drug that can cause damage to organs within 3 months
4. Administration of any prescription drug or non-prescription drug 2 weeks before initial dose
5. Before initial dose, participation in any other clinical trials within 3 months
6. Blood donation 3 months before this study, or plan to have blood donation during or one month after this study
7. Diagnosis of clinical evident diseases 2 weeks before initial dose
8. Primary diseases to vital organs
9. Physically or mentally disabled
10. Medical history of specific allergy (asthma, measles, eczematous dermatitis), or known to allergic to similar (including excipients)
11. Any other surgical or internal medicinal conditions that might cause damage to study subjects or will change the absorption, distribution, metabolism and elimination of investigational drug, including:
* inflammatory intestinal syndrome, peptic ulcer, alimentary tract hemorrhage
* a history of severe gastrointestinal tract operation, such as gastrectomy, gastrosmoty / jejunostomy or large bowel resection
* a history of hepatic disease or laboratory examination findings such as ALT, AST, γ-GT or T-Bili showing clinically significant abnormalities to liver
* a history of renal disease or laboratory examination findings such as creatinine, urea nitrogen, or albuminuria showing clinically significant abnormalities to kidney
* urination disorder or dysuresia.
12. A history of immunological deficiency disease, or HIV positive
13. HBV or HCV positive
14. Women undergone menstrual period during study
15. Consumption of a significant amount of smoking or drinking, that is drinking more than 28 units of alcohol per week (1 unit: 285ml of beer, 25ml of liquor, or 1 glass of wine), or smoking more than 2 cigarettes
16. Frequent use of sedatives, hypnotics, stabilizers or other addictive drugs
17. Consumption of more than 8 cups of tea, coffee, and or caffeine beverages
18. Unable to complete this study for any others reasons.
19. Investigators.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
19 Years
Maximum Age:
25 Years
Study:
NCT02095704
Study Brief:
Protocol Section:
NCT02095704