Status:
COMPLETED
Efficacy and Safety After Multiple Doses of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules in Helicobacter Pylori Infected-positive Participants
Lead Sponsor:
TenNor Therapeutics (Suzhou) Limited
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06076694
Start Date
June 26 2022
End Date
September 20 2022
Last Update
December 12 2023
Active Locations (1)
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1
The First Hospital of Jilin University
Changchun, Jilin, China