A Phase Ⅰb/Ⅱa, Single-center, Randomized, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Helicobacter Pylori Eradication Efficacy in Asymptomatic Subjects With Helicobacter Pylori Infection After Multiple Doses of TNP-2198 Capsules Combined With Rabeprazole Sodium Enteric-coated Tablets, or TNP-2198 Capsules Combined With Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 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 phase Ⅰb/Ⅱa, single-center, randomized, open-label study was designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary Helicobacter Pylori eradication efficacy in asymptomatic subjects with Helicobacter Pylori infection after multiple doses of TNP-2198 capsules combined with rabeprazole sodium enteric-coated tablets, or TNP-2198 capsules combined with rabeprazole sodium enteric-coated tablets and amoxicillin capsules.
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
- Double (Participant, Investigator)
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
- 是
入选标准
- •Signing the informed consent form and full understanding study contents, process and possible adverse reactions before participation in the study;
- •Able to complete the study according to the requirements of the study protocol;
- •The subject (including the partner) is willing to take effective contraceptive measures voluntarily without pregnancy plan in the next 6 months;
- •Male and female subjects aged 18 to 65 years (inclusive);
- •Male subjects' body weight ≥ 50 kg, or female subjects' body weight ≥ 45 kg, with body mass index within the range of 18-30 kg/m2 (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).
- •Clinical laboratory test results are within normal limits or abnormal but without clinical significance as judged by the investigator.
排除标准
- •History of Helicobacter Pyloreradication 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 t;
- •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 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
TNP2198 capsules 200 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
干预措施: TNP-2198 (Drug)
Group A
TNP2198 capsules 200 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
干预措施: Rabeprazole Sodium (Drug)
Group B
TNP2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
干预措施: TNP-2198 (Drug)
Group B
TNP2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
干预措施: Rabeprazole Sodium (Drug)
Group C
TNP2198 capsules 600 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
干预措施: TNP-2198 (Drug)
Group C
TNP2198 capsules 600 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID
干预措施: Rabeprazole Sodium (Drug)
Group D
TNP2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID + amoxicillin capsules 1g BID
干预措施: TNP-2198 (Drug)
Group D
TNP2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID + amoxicillin capsules 1g BID
干预措施: Rabeprazole Sodium (Drug)
Group D
TNP2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID + amoxicillin capsules 1g BID
干预措施: Amoxicillin (Drug)
结局指标
主要结局
The Eradication Rate of Helicobacter Pylori Infection
时间窗: Urea breath test is assessed 4-6 weeks after the treatment (Day 44~ Day 50)
Eradication rate of H. pylori is defined as negative urea breath test result.
次要结局
未报告次要终点