efficacy and safety after multiple doses of tnp-2198 capsules, rabeprazole sodium enteric-coated tablets and amoxicillin capsules in helicobacter pylori infected-positive participants

Conditions: Helicobacter Pylori Infection

Summary: this is a single-center, randomized, open-label phase ic/iib clinical study to evaluate the efficacy and safety of tnp-2198 capsules, rabeprazole sodium enteric-coated tablets and amoxicillin capsules combined with multiple doses of rabeprazole sodium enteric-coated tablets and amoxicillin capsules compared with multiple doses of rabeprazole sodium enteric-coated tablets and amoxicillin capsules combined with multiple doses in helicobacter pylori infection-positive population.


Eligibility criteria:
inclusion criteria: * signing the informed consent form (icf); * male and female subjects aged 18 to 65 years (inclusive); * health condition: 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 signs; * positive result of 14c urea breath test (ubt); * the subject (including the partner) is willing to take effective contraceptive measures voluntarily without pregnancy plan in the next 6 months; * willing to follow and able to complete all trial procedures. exclusion criteria: * history of helicobacter pylori eradication therapy (including participation in other clinical studies of helicobacter pylori eradication); * average daily consumption of more than 5 cigarettes within 3 months prior to the start of the study; * history of hypersensitivity to study drug or its excipients, or 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); * 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; * taking orally 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; * those who have participated in, or are still participating in clinical studies within 1 months before taking 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 during the screening period or during the study, or have positive serum pregnancy test results; * with symptoms or previous history of cardiovascular, digestive, respiratory, urinary, neurological, hematologic, immunological, endocrine system diseases or 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); * those who have positive tests results of viral hepatitis (including hepatitis b and c), hiv antibody, treponema pallidum antibody (additional rapid plasma reagin（rpr）test is required for those with positive treponema pallidum antibody); * acute illness occurs or concomitant medication is used from the date of signing the informed consent to the date prior to study medication; * consumption of chocolate, any caffeine- or xanthine-containing food or drink within 48 hours prior to taking the study drug; * consumption of any alcoholic product within 48 hours prior to taking the study drug; * those who have positive test result of urine drug screening or history of drug abuse or drug addiction within the past 5 years; * those who have other conditions that, in the opinion of the investigator, make participation in this study inappropriate.