Efficacy and Safety After Multiple Doses of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules in Helicobacter Pylori Infected-positive Participants
Phase 2
Completed
- Conditions
- Helicobacter Pylori Infection
- Interventions
- Registration Number
- NCT06076694
- Lead Sponsor
- TenNor Therapeutics (Suzhou) Limited
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A TNP-2198 TNP-2198 capsules 400 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; Twice daily (BID) for 14 days Group A Rabeprazole Sodium TNP-2198 capsules 400 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; Twice daily (BID) for 14 days Group A Amoxicillin TNP-2198 capsules 400 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; Twice daily (BID) for 14 days Group B Rabeprazole Sodium TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; BID for 14 days Group B Amoxicillin TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; BID for 14 days Group C TNP-2198 TNP-2198 capsule 600 mg + rabeprazole sodium enteric-coated tablets 20 mg; Three times daily (TID) for 14 days Group C Rabeprazole Sodium TNP-2198 capsule 600 mg + rabeprazole sodium enteric-coated tablets 20 mg; Three times daily (TID) for 14 days Group D Rabeprazole Sodium TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1g; TID for 7 days Group D Amoxicillin TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1g; TID for 7 days Control group Amoxicillin Rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g Group B TNP-2198 TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; BID for 14 days Group D TNP-2198 TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1g; TID for 7 days Control group Rabeprazole Sodium Rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g
- Primary Outcome Measures
Name Time Method The Eradication Rate of Helicobacter Pylori Infection Group A, B,C,control group: Urea breath test is assessed Day 44~Day 50 after the first dose; Group D: Urea breath test is assessed Day 37~ Day 43 after the first dose Eradication rate of H. pylori is defined as negative urea breath test result.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The First Hospital of Jilin University
🇨🇳Chang chun, Jilin, China