Efficacy and Safety After Multiple Doses of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules in Helicobacter Pylori Infected-positive Participants
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group A TNP-2198 capsules 400 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; Twice daily (BID) for 14 days |
Drug: TNP-2198
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
Other Names:
Drug: Rabeprazole Sodium
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
Drug: Amoxicillin
Group A,Group B,Control group: Amoxicillin capsules 1g, BID, 14days Group D : Amoxicillin capsules 1g, TID, 7 days
|
| Experimental: Group B TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; BID for 14 days |
Drug: TNP-2198
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
Other Names:
Drug: Rabeprazole Sodium
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
Drug: Amoxicillin
Group A,Group B,Control group: Amoxicillin capsules 1g, BID, 14days Group D : Amoxicillin capsules 1g, TID, 7 days
|
| Experimental: Group C TNP-2198 capsule 600 mg + rabeprazole sodium enteric-coated tablets 20 mg; Three times daily (TID) for 14 days |
Drug: TNP-2198
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
Other Names:
Drug: Rabeprazole Sodium
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
|
| Experimental: Group D TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1g; TID for 7 days |
Drug: TNP-2198
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
Other Names:
Drug: Rabeprazole Sodium
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
Drug: Amoxicillin
Group A,Group B,Control group: Amoxicillin capsules 1g, BID, 14days Group D : Amoxicillin capsules 1g, TID, 7 days
|
| Active Comparator: Control group Rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g |
Drug: Rabeprazole Sodium
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
Drug: Amoxicillin
Group A,Group B,Control group: Amoxicillin capsules 1g, BID, 14days Group D : Amoxicillin capsules 1g, TID, 7 days
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Hospital of Jilin University | Chang chun | Jilin | China |
Sponsors and Collaborators
- TenNor Therapeutics (Suzhou) Limited
Investigators
- Study Director: TenNor Clinical Trials, TenNor
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TNP-2198-06