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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT03180333
Eligibility Criteria:
Inclusion Criteria:
1. Healthy volunteers aged 18 to 45 years old ;
2. Body mass index (BMI) above/equal 19 and below 24 kg/m2;
3. Child bearing potential, has a negative serum pregnancy test at screening period, and agrees to use contraceptions consistently and correctly in 14 days after dosing;
4. Subjects with no cardiovascular, liver, kidney, digestive tract, nervous and mental and other acute or chronic diseases that may affect the safety and pharmacokinetic of drug;
5. Signed informed consent voluntarily.
Exclusion Criteria:
1. Subjects not meet the inclusion criteria;
2. Abnormal clinically significant laboratory results;
3. Abnormal clinically significant electrocardiogram (ECG);
4. A positive hepatitis B surface antigen, hepatitis C or HIV test result;
5. History of hypersensitivity or allergy to any of the study drugs or to drugs of similar chemical classes;
6. Addicted to smoking and drinking;
7. Drink in 36 hours before post-dosing of study drug;
8. Ingest any foods or beverages which may affect pharmacokinetics;
9. Drug abuse,a history of poisoning;
10. Subjects who had received other medications within 2 weeks prior to the first administration of Investigational Product，and the original and main metabolites were not completely eliminated ;
11. Subjects who participated in any other clinical trials within 3 months prior to the first administration of Investigational Product;
12. Subjects who had suffered from hemorrhage or blood donation over 200ml will be excluded;
13. Subjects over exercised accompanied with fatigue and muscle aches within 1 week period to the first administration of Investigational Product;
14. Children,women who are pregnant,lactating,with childbearing potential and who are using acyeterions;
15. Subjects in the opinion of the investigator, could not participate in this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03180333
Study Brief:
Protocol Section:
NCT03180333