Efficacy and Safety After Multiple Doses of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules in Helicobacter Pylori Infected-positive Participants
Helicobacter Pylori Infection
About this trial
This is an interventional treatment trial for Helicobacter Pylori Infection
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.
Sites / Locations
- The First Hospital of Jilin University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Active Comparator
Group A
Group B
Group C
Group D
Control group
TNP-2198 capsules 400 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; Twice daily (BID) for 14 days
TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; BID for 14 days
TNP-2198 capsule 600 mg + rabeprazole sodium enteric-coated tablets 20 mg; Three times daily (TID) for 14 days
TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1g; TID for 7 days
Rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g