临床试验/NCT07262346

NCT07262346尚未招募1 期

Clinical Pharmacokinetic Study of Hydronione Capsules in Healthy Chinese Subjects (Ⅰd)

Beijing Continent Pharmaceutical Co, Ltd.1 个研究点分布在 1 个国家目标入组 138 人开始时间: 2025年12月5日最近更新: 2025年12月3日

干预措施

试验速览

阶段: 1 期
状态: 尚未招募
发起方
入组人数: 138
试验地点: 1
主要终点: SAD :Blood drug PK parameters(Cmax)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Based on the Phase I (Ia, Ib, Ic) clinical pharmacokinetic study of Hydronidone Capsules, a clinical pharmacokinetic trial of Hydronidone Capsules (specification: 30 mg/capsule) was conducted, including single-dose administration, multiple-dose administration, and a food-effect study. The aim was to investigate the safety, tolerability, and pharmacokinetic characteristics of higher doses of Hydronidone Capsules (specification: 30 mg/capsule) in healthy subjects, in preparation for future expansion of indications.

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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy subjects, both male and female;
•Age: 18-45 years;
•Weight: Male ≥50 kg, Female ≥45 kg, with a BMI between 19 and 26 (BMI = weight (kg)/height² (m²));
•Pass a comprehensive health examination, meaning no abnormalities or no clinically significant findings in the following: vital signs, physical examination, blood and urine routine tests, blood pregnancy test, blood glucose, blood lipids, blood electrolytes, hepatitis B surface antigen, liver and kidney function, hepatitis C, HIV and syphilis antibody tests, 12-lead electrocardiogram, nicotine screening, urine drug screening, alcohol breath test, chest X-ray, etc.;
•Have been fully informed about the nature, significance, potential benefits, possible inconveniences, and risks of the study prior to participation, and voluntarily agree to take part in this clinical trial. Subjects must be able to communicate well with the researchers, comply with all study requirements, and have the capacity to understand and sign the written informed consent form.

排除标准

•(Inquiry) Participation in any other clinical trial within three months prior to this study;
•(Inquiry) Presence of any disease that may affect the safety of the trial or the pharmacokinetics of the drug, including but not limited to: past or current diseases of the heart, liver, kidneys, endocrine system, digestive tract, immune system, respiratory system, nervous system, or psychiatric disorders [particularly cardiovascular diseases or individuals at risk of cardiovascular diseases, any gastrointestinal diseases affecting drug absorption (e.g., irritable bowel syndrome, inflammatory bowel disease), active pathological bleeding (e.g., peptic ulcer), urticaria, epilepsy, allergic rhinitis, eczematous dermatitis, asthma, active tuberculosis, etc.];
•(Inquiry) Allergic constitution: such as a history of drug or food allergies, skin allergies, or lactose intolerance;
•(Inquiry) Use of any drugs that inhibit or induce hepatic drug metabolism within 28 days before taking the investigational drug (common enzyme inducers: barbiturates such as phenobarbital, carbamazepine, aminoglutethimide, griseofulvin, meprobamate, phenytoin, glutethimide, rifampicin, dexamethasone; common enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamides);
•Use of any medications (including herbal medicines) or health products within 14 days before the first dose;
•(Inquiry) Individuals with special dietary requirements who cannot adhere to a standardized diet (e.g., intolerance to standard meals) or those with difficulty swallowing;
•(Inquiry) Inability to tolerate venipuncture and/or a history of blood or needle phobia;
•(Inquiry) Habitual excessive consumption of tea, coffee, or caffeine-containing beverages (more than 8 cups per day, 1 cup = 250 mL); or consumption of any caffeine-containing foods or beverages (e.g., coffee, strong tea, chocolate, etc.) within 48 hours before the first dose, or adherence to any special diet that may affect drug absorption, distribution, metabolism, or excretion;
•(Inquiry) History of excessive alcohol consumption (defined as more than 28 standard units per week for men and more than 21 standard units per week for women (1 standard unit contains 14 g of alcohol, equivalent to 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine)); or regular alcohol consumption (more than 14 standard units per week) within 6 months prior to the trial; or consumption of any alcohol-containing products within 24 hours before the first dose;
•(Inquiry) Blood donation or significant blood loss (exceeding 450 mL) within 3 months before the first dose, or plans to donate blood or blood components during the study or within 3 months after its completion;
•(Inquiry) Occurrence of an acute illness during the pre-study screening phase or before administration of the study drug;
•(Inquiry) Consumption of any foods or beverages known to induce or inhibit hepatic metabolic enzymes (e.g., grapefruit, mango, dragon fruit, grape juice, orange juice, etc., which are rich in flavonoids or citrus glycosides) within 24 hours before the first dose;
•(Inquiry) Surgery within three months before screening or plans to undergo surgery during the study period;
•(Inquiry) History of drug abuse or substance abuse;
•(Inquiry) Smoking more than 5 cigarettes per day within 14 days before screening, or inability to discontinue the use of any tobacco products during the trial period;
•(Inquiry) Smoking or use of any tobacco products between screening and hospital admission;
•Positive nicotine test result;
•Alcohol breath test result greater than 0.0 mg/100 mL;
•Positive urine drug screen result;
•Pregnant or breastfeeding women;
•Individuals planning to conceive within 6 months after the trial or unwilling to use non-pharmacological contraceptive measures;
•Any condition deemed by the investigator as potentially affecting the subject's ability to provide informed consent, comply with the trial protocol, or participate in the trial in a way that could impact the results or subject safety.

研究组 & 干预措施

SAD:180mg drug group

Experimental

On the morning of D1, the patients took 180mg of hydronidone capsules orally on an empty stomach once.

干预措施: Hydronidone capsules (Drug)

SAD:120mg drug group

Experimental

On the morning of D1, the patients took 120mg of hydronidone capsules orally on an empty stomach once.

干预措施: Hydronidone capsules (Drug)

SAD:240mg drug group

Experimental

On the morning of D1, the patients took 240mg of hydronidone capsules orally on an empty stomach once.

干预措施: Hydronidone capsules (Drug)

SAD:300mg drug group

Experimental

On the morning of D1, the patients took 300mg of hydronidone capsules orally on an empty stomach once.

干预措施: Hydronidone capsules (Drug)

SAD:360mg drug group

Experimental

On the morning of D1, the patients took 360mg of hydronidone capsules orally on an empty stomach once.

干预措施: Hydronidone capsules (Drug)

SAD:420mg drug group

Experimental

On the morning of D1, the patients took 420mg of hydronidone capsules orally on an empty stomach once.

干预措施: Hydronidone capsules (Drug)

MAD: drug group1 (dosage to be determined)

Experimental

Single dose on an empty stomach on Days 1 and 8; on Days 2-7, take oral medication once every 8 hours.

干预措施: Hydronidone capsules (Drug)

MAD: drug group 2 (dosage to be determined)

Experimental

Single dose on an empty stomach on Days 1 and 8; on Days 2-7, take oral medication once every 8 hours.

干预措施: Hydronidone capsules (Drug)

MAD: drug group 3 (dosage to be determined)

Experimental

Single dose on an empty stomach on Days 1 and 8; on Days 2-7, take oral medication once every 8 hours.

干预措施: Hydronidone capsules (Drug)

Study on the Interaction between Food and Drugs:drug group1 (dosage to be determined)

Experimental

Period 1 involved administration under fasting conditions, with a 7-day washout period starting on Day 2. Administration for Period 2 was conducted on Day 8.

干预措施: Hydronidone capsules (Drug)

Study on the Interaction between Food and Drugs:drug group2 (dosage to be determined)

Experimental

In Period 1, a high-fat meal was consumed first, followed by drug administration within 30 minutes, with washout commencing on Day 2. After a total 7-day washout period, the second period of dosing was administered on Day 8.

干预措施: Hydronidone capsules (Drug)

SAD:Placebo group

Placebo Comparator

On the morning of D1, the patients took 180mg of hydronidone capsules orally on an empty stomach once.

干预措施: Placebo capsules (Drug)

MAD:Placebo group

Placebo Comparator

Single dose on an empty stomach on Days 1 and 8; on Days 2-7, take oral medication once every 8 hours.

干预措施: Placebo capsules (Drug)