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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The Eradication Rate of Helicobacter Pylori Infection
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Group A
TNP-2198 capsules 400 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; Twice daily (BID) for 14 days
干预措施: TNP-2198 (Drug)
Group A
TNP-2198 capsules 400 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; Twice daily (BID) for 14 days
干预措施: Rabeprazole Sodium (Drug)
Group A
TNP-2198 capsules 400 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; Twice daily (BID) for 14 days
干预措施: Amoxicillin (Drug)
Group B
TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; BID for 14 days
干预措施: TNP-2198 (Drug)
Group B
TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; BID for 14 days
干预措施: Rabeprazole Sodium (Drug)
Group B
TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; BID for 14 days
干预措施: Amoxicillin (Drug)
Group C
TNP-2198 capsule 600 mg + rabeprazole sodium enteric-coated tablets 20 mg; Three times daily (TID) for 14 days
干预措施: TNP-2198 (Drug)
Group C
TNP-2198 capsule 600 mg + rabeprazole sodium enteric-coated tablets 20 mg; Three times daily (TID) for 14 days
干预措施: Rabeprazole Sodium (Drug)
Group D
TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1g; TID for 7 days
干预措施: TNP-2198 (Drug)
Control group
Rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g
干预措施: Amoxicillin (Drug)
Group D
TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1g; TID for 7 days
干预措施: Rabeprazole Sodium (Drug)
Group D
TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1g; TID for 7 days
干预措施: Amoxicillin (Drug)
Control group
Rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g
干预措施: Rabeprazole Sodium (Drug)
结局指标
主要结局
The Eradication Rate of Helicobacter Pylori Infection
时间窗: 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.
次要结局
未报告次要终点