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:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
NCT ID:
NCT06081712
Eligibility Criteria:
Inclusion Criteria:
* Those signed the informed consent form and fully understood the study contents, process and possible adverse reactions before participation in the study;
* Those are able to complete the study according to the requirements in the study protocol;
* Those (including the partner) are willing to use effective contraceptions from the screening up to 6 months after the last dose of study drug;
* Male and female subjects aged 18-55 years (inclusive);
* Male subjects no less than 50 kg and female subjects no less than 45 kg. Body mass index (BMI) = body weight (kg)/height2 (m2); BMI: 18-28kg/m2 (inclusive);
* Health status: no clinically significant history of heart, liver, kidney, digestive tract, nervous system, respiratory system diseases, mental disorders or metabolic abnormalities;
* Normal results or clinically insignificant abnormal results in physical examinations and vital sign assessment;
* Positive result of 14C urea breath test (UBT).
Exclusion Criteria:
* Average daily consumption of more than 5 cigarettes within 3 months before the study;
* Allergic constitution (allergy to multiple drugs and food);
* History of drug and/or alcohol abuse (mean consumption of ≥ 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of liquor, or 100 mL of wine);
* History of Helicobacter Pylori eradication;
* Blood donation or massive blood loss (\> 450 mL) within 3 months prior to screening;
* Using any drug that changes liver enzyme activity within 28 days prior to screening;
* Using any prescription drug, over-the-counter drug, any vitamin product, or herbal medicine within 14 days prior to screening;
* Taking special diet (including dragon fruit, mango, grapefruit, etc.) or strenuous exercise, or having other factors that affect drug absorption, distribution, metabolism, excretion, etc., within 2 weeks prior to screening;
* Significant changes in diet or exercise habits recently;
* Administration of any other study drug or participation in any drug clinical study within 3 months before administration of the study drug;
* With difficulty in swallowing or history of any gastrointestinal diseases that affect drug absorption;
* With any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis or gastric and duodenal ulcers;
* With clinically significant ECG abnormalities;
* Female subjects who are lactating or having positive serum pregnancy test during screening or during the study;
* With symptoms or previous history of cardiovascular, digestive, respiratory, urinary, neurological, hematologic, immunological, endocrine system diseases, tumor, or psychiatric diseases;
* Clinically significant abnormalities in clinical laboratory tests, or other clinically significant findings (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, neoplastic, pulmonary, immunological, psychiatric, or cardiovascular disease);
* Positive viral hepatitis (including hepatitis B and C), HIV antigen/antibody, treponema pallidum antibody;
* Acute illness or concomitant medication from the time of signing the informed consent to the time of study medication;
* Intake of chocolate, any caffeine- or xanthine-containing food or drink within 48 hours prior to administration of study drug;
* Intake of any alcohol-containing product within 48 hours before administration of study drug;
* Positive urine drug screening or history of drug abuse or drug addiction within the past 5 years;
* Other conditions that, in the opinion of the investigator, make the patient participating in this study inappropriate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06081712
Study Brief:
Protocol Section:
NCT06081712