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 @ 12:24 PM
Ignite Modification Date:
2025-12-24 @ 12:24 PM
NCT ID:
NCT04551261
Eligibility Criteria:
Inclusion Criteria:
* Males or females, of any race, between 18 and 50 years of age, inclusive, at Screening;
* Body mass index between 18.0 and 28.0 kg/m2, inclusive, at Screening;
* Females of childbearing potential and male subjects will agree to use contraception from screening to the 6 months after the last administration.
Exclusion Criteria:
* In the 12 months prior to screening, observing clinical significance of the following diseases, including but not limited to, gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental, or cardio-cerebrovascular diseases;
* Allergic constitution (multiple drug and food allergies);
* A history of alcoholism;
* Take any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days of screening;
* Any drug that changes the liver enzyme activity, such as barbiturates and Rifampicin, was taken within 30 days before screening;
* P-GP, BCRP, OATP1B1, OATP1B3, OAT1, OAT3 or MRP4 inhibitors or inducers, such as azithromycin, pantoprazole or St. John's herb, etc., was taken within 30 days before screening;
* Female subjects are lactating or have positive blood pregnancy results during the screening period;
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT04551261
Study Brief:
Protocol Section:
NCT04551261