Efficacy and Safety After Multiple Doses of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules in Helicobacter Pylori Infected-positive Participants
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Helicobacter Infections
Intervention: TNP-2198; Rabeprazole Sodium; Amoxicillin
Intervention description: Group A, TNP-2198 capsules 400mg(4 capsules),BID, 14days Group B, TNP-2198 capsules 600mg(6 capsules),BID, 14days Group C , TNP-2198 capsules 600mg(6 capsules),TID, 14days Group D, TNP-2198 capsules 600mg(6 capsules),TID, 7days; Group A,Group B,Control group: Rabeprazole sodium enteric-coated tablets 20 mg, BID, 14days Group C :Rabeprazole sodium enteric-coated tablets 20 mg, TID, 14 days Group D : Rabeprazole sodium enteric-coated tablets 20 mg, TID, 7 days; Group A,Group B,Control group: Amoxicillin capsules 1g, BID, 14days Group D : Amoxicillin capsules 1g, TID, 7 days
Intervention MeSH terms: Amoxicillin; Rabeprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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.