A Phase 1, Single-center, Double-blind, Randomized, Placebo-controlled Clinical Trial to Evaluate the Safety and Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Administrations of TNP-2092 Capsules in Combination With Rabeprazole Sodium Enteric-coated Tablets in Asymptomatic Healthy Subjects With Helicobacter Pylori Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration Versus Time Curve from 0 to the Last Measurable Concentration (AUC0-t)
研究概览
简要总结
A phase 1, single-center, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and tolerability, pharmacokinetics, and preliminary efficacy of multiple administrations of TNP-2092 Capsules in combination with Rabeprazole Sodium Enteric-coated Tablets in asymptomatic healthy subjects with Helicobacter pylori infection
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Those who have signed the Informed Consent Form before the trial, and fully understand the trial content, procedures, and possible adverse reactions.
- •Those who are able to complete the study according to the requirements of the protocol.
- •Subjects (including male subjects) who agree to have no pregnancy plan and voluntarily take effective contraceptive measures from the screening date to 6 months after the last administration of the investigational product.
- •Sex: male or female.
- •Age: 18 - 50 years (inclusive).
- •BMI: 18.0 - 28.0 kg/m2 (inclusive).
- •Subjects who do not smoke, or have smoked less than 5 cigarettes per day within 3 months before screening; subjects who do not drink alcohol, or have drunk less than 14 units of alcohol per week (1 unit of alcohol = 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) within 6 months before screening; subjects who have not smoked or drunk alcohol within 48 hours before admission to the study site.
- •Subjects whose clinical laboratory test results are within the normal range or whose test results are abnormal but judged by the investigator to be of no clinical significance.
- •Subjects with a positive 14C urea breath test(UBT) result.
排除标准
- •Subjects with an allergic constitution, a history of allergic diseases or a history of drug allergy.
- •Subjects with a history of alcohol or drug abuse in the past 10 years.
- •Subjects who have donated blood within 3 months before enrollment.
- •Subjects with regular use of any prescription/over-the-counter drugs, including vitamins, minerals, nutritional supplements or herbs, within 2 weeks before enrollment and during the study period.
- •Subjects who have taken any drug that changes the activity of liver enzymes 28 days before taking the investigational product or during the study.
- •Subjects who have participated in any clinical trials within 3 months before enrollment.
- •Subjects with a history of eradication of Helicobacter pylori.
- •Subjects who are suffering or have suffered from digestive tract diseases, including digestive tract ulcer, etc.
- •Subjects with symptoms or past medical history of cardiovascular, respiratory, urinary, neurological, blood, immune, endocrine system diseases or tumor, mental illness, or any situation which, in the opinion of the investigator, may threaten the safety of the subjects or affect the correctness of the trial results.
- •Subjects whose blood pressure remains above 150/95 mmHg after retest.
- •Pregnant or lactating women.
- •Subjects who are HIV positive, syphilis positive, hepatitis B surface antigen positive, hepatitis C antibody positive.
- •Subjects who have had caffeinated beverages or foods (coffee, tea, coke, chocolate and energy drinks), grapefruit (fruit juice) and alcohol within 48 hours (2 days) before the clinical study.
- •Other circumstances deemed by the investigator to be unsuitable for the subject to participate in this study.
研究组 & 干预措施
Study Group
Rabeprazole sodium enteric-coated tablets + TNP-2092 capsules (n = 10)
干预措施: TNP-2092 capsules (Drug)
Study Group
Rabeprazole sodium enteric-coated tablets + TNP-2092 capsules (n = 10)
干预措施: Rabeprazole sodium enteric-coated tablets (Drug)
Control Group
Rabeprazole sodium enteric-coated tablets + TNP-2092 capsules placebo (n = 10)
干预措施: TNP-2092 capsules placebo (Drug)
Control Group
Rabeprazole sodium enteric-coated tablets + TNP-2092 capsules placebo (n = 10)
干预措施: Rabeprazole sodium enteric-coated tablets (Drug)
结局指标
主要结局
Area Under the Plasma Concentration Versus Time Curve from 0 to the Last Measurable Concentration (AUC0-t)
时间窗: Within 15 minutes before the morning dose of Rabeprazole Sodium Enteric-coated Tablets, and 20 minutes, 50 minutes, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 8, 10 and 12 hours after the morning dose of Rabeprazole Sodium Enteric-coated Tablets
Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Maximum Observed Plasma Concentration (Cmax) of TNP-2092
时间窗: Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after administration]
Plasma concentrations of TNP-2092 were measured by a specific and validated assay at specified time points
Percentage of Participants With Adverse Events (AEs)
时间窗: Day 1 to Day 49
An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf)
时间窗: Within 15 minutes before the morning dose of Rabeprazole Sodium Enteric-coated Tablets, and 20 minutes, 50 minutes, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 8, 10 and 12 hours after the morning dose of Rabeprazole Sodium Enteric-coated Tablets
Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma Pharmacokinetics (PK) parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods
次要结局
未报告次要终点