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 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT03020134
Eligibility Criteria:
Inclusion Criteria:
* Willing and able to provide written informed consent
* Overall health situation is good according to disease history, physical exam, physical symptoms, laboratory tests and 12 lead ECG.
* If female, surgically sterilized or willingness to use reliable method of birth control during the study and for 30 days after the last dose of study medication.
* If male, surgically sterilized or willingness to use reliable method of birth control during the study and for 30 days after the last dose of study medication.
* If female, negative pregnancy test during the screening period.
* Others as specified in the detailed protocol
Exclusion Criteria:
* History or presence of cardiovascular disease, respiratory disease, endocrine and metabolic system disease, urinary system, digestive system, hematological system diseases, nervous system or Psychiatric diseases, and acute or chronic infectious disease and malignant tumor.
* Positive test in any of the HAV-IgM,HBsAg, HCV Ab, HIV Ab, Syphilis Ab
* History of gastrointestinal surgery, trunk vagotomy, intestinal excision or any other surgeries that could disturb gastrointestinal motility and PH absorption.
* Female during pregnancy, breastfeeding, period and unwilling to take reliable birth control method.
* Others as specified in the detailed protocol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03020134
Study Brief:
Protocol Section:
NCT03020134