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 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT03789734
Eligibility Criteria:
Inclusion Criteria:
1. Male and female subjects between 19-55 years of age
2. BMI: 19\~28kg/m2(male), 18\~25kg/m2(female) at screening test
3. Able to provide consent to participate and having signed an Informed Consent Form (ICF)
4. The subjects can obey the demands of the scheme
Exclusion Criteria:
1. Subject has a clinically significant disease or history of liver, kidney, cardiovascular system, endocrine system, musculoskeletal system, digestive system, respiratory system, neuropsychiatry, blood∙tumor system.
2. Hypersensitive to the lactobacillus-containing food (such as yogurt) and the lactobacillus preparation and the investigational drug
3. Subject has received a investigational drug or a bioequivalence study drug within 90 days of the randomization
4. Subject has received steroids or other immunosuppressive drugs within 30 days of randomization
5. Positive serum test results for hepatitis C virus, hepatitis B virus, HIV or syphilis
6. Those who do not use of a medically acceptable method of contraception during the trial, or who plan to provide sperm
7. Pregnant women
8. Subject has genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
9. Subject has abnormal clinical laboratory test results
10. Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
55 Years
Study:
NCT03789734
Study Brief:
Protocol Section:
NCT03789734