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 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT06337604
Eligibility Criteria:
Inclusion Criteria:
* Those who have signed the Informed Consent Form before the trial, and fully understand the trial content, procedures, and possible adverse reactions.
* Those who are able to complete the study according to the requirements of the protocol.
* Subjects (including male subjects) who agree to have no pregnancy plan and voluntarily take effective contraceptive measures from the screening date to 6 months after the last administration of the investigational product.
* Sex: male or female.
* Age: 18 - 50 years (inclusive).
* BMI: 18.0 - 28.0 kg/m2 (inclusive).
* Subjects who do not smoke, or have smoked less than 5 cigarettes per day within 3 months before screening; subjects who do not drink alcohol, or have drunk less than 14 units of alcohol per week (1 unit of alcohol = 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) within 6 months before screening; subjects who have not smoked or drunk alcohol within 48 hours before admission to the study site.
* Subjects whose clinical laboratory test results are within the normal range or whose test results are abnormal but judged by the investigator to be of no clinical significance.
* Subjects with a positive 14C urea breath test(UBT) result.
Exclusion Criteria:
* Subjects with an allergic constitution, a history of allergic diseases or a history of drug allergy.
* Subjects with a history of alcohol or drug abuse in the past 10 years.
* Subjects who have donated blood within 3 months before enrollment.
* Subjects with regular use of any prescription/over-the-counter drugs, including vitamins, minerals, nutritional supplements or herbs, within 2 weeks before enrollment and during the study period.
* Subjects who have taken any drug that changes the activity of liver enzymes 28 days before taking the investigational product or during the study.
* Subjects who have participated in any clinical trials within 3 months before enrollment.
* Subjects with a history of eradication of Helicobacter pylori.
* Subjects who are suffering or have suffered from digestive tract diseases, including digestive tract ulcer, etc.
* Subjects with symptoms or past medical history of cardiovascular, respiratory, urinary, neurological, blood, immune, endocrine system diseases or tumor, mental illness, or any situation which, in the opinion of the investigator, may threaten the safety of the subjects or affect the correctness of the trial results.
* Subjects whose blood pressure remains above 150/95 mmHg after retest.
* Pregnant or lactating women.
* Subjects who are HIV positive, syphilis positive, hepatitis B surface antigen positive, hepatitis C antibody positive.
* Subjects who have had caffeinated beverages or foods (coffee, tea, coke, chocolate and energy drinks), grapefruit (fruit juice) and alcohol within 48 hours (2 days) before the clinical study.
* Other circumstances deemed by the investigator to be unsuitable for the subject to participate in this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT06337604
Study Brief:
Protocol Section:
NCT06337604