ChiCTR2500106651 版本V1.0 版本创建时间2025/07/28 11:31:56 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2500106651 

最近更新日期：

Date of Last Refreshed on：

 2025-07-28 11:31:45 

注册时间：

Date of Registration：

 2025-07-28 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

单中心、开放、单次给药试验评价硝酮嗪片在肾功能不全和健康受试者中药代动力学特征

Public title：

Single-center, open, single-dose trial to evaluate the pharmacokinetic profile of tetramethylpyrazine nitrone (TBN) tablets in renal insufficiency and healthy subjects

注册题目简写：

English Acronym：

研究课题的正式科学名称：

单中心、开放、单次给药试验评价硝酮嗪片在肾功能不全和健康受试者中药代动力学特征

Scientific title：

Single-center, open, single-dose trial to evaluate the pharmacokinetic profile of tetramethylpyrazine nitrone (TBN) tablets in renal insufficiency and healthy subjects

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

陈瑶 

研究负责人：

沈雄虎,杨恩月 

Applicant：

Yao Chen 

Study leader：

Xionghu Shen, Enyue Yang 

申请注册联系人电话：

Applicant telephone：

 +86 185 2376 0907

研究负责人电话：

Study leader's
telephone：

+86 155 2677 0368

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 yaochen@magpiepharma.cn

研究负责人电子邮件：

Study leader's E-mail：

 xim918@126.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

广东省广州市黄埔区科学城揽月路80号广州科技创新基地F栋4楼

研究负责人通讯地址：

中国吉林省延吉市局子街1327号

Applicant address：

Building F, 4th Floor, Science & Technology Invovation Base, No.80 Lanyue Rd., Science City, Huangpu District, Guangzhou City, Guangdong Province, China

Study leader's address：

No. 1327, Bureau Street, Yanji City, Jilin Province, China

申请注册联系人邮政编码：

Applicant postcode：

 510632

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

广州喜鹊医药有限公司

Applicant's institution：

Guangzhou Magpie Pharmaceuticals Co., Ltd

研究负责人所在单位：

延边大学附属医院

Affiliation of the Leader：

Yanbian University Affiliated Hospital

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2022(伦审)-026-01

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

延边大学附属医院（延边医院）药物/器械临床试验伦理委员会

Name of the ethic committee：

Ethics Committee of Drug Clinical Trials of Yanbian University Affiliated Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-06-13 00:00:00

伦理委员会联系人：

刘延翔

Contact Name of the ethic committee：

Yanxiang Liu

伦理委员会联系地址：

中国吉林省延吉市局子街1327号

Contact Address of the ethic committee：

No. 1327, Bureau Street, Yanji City, Jilin Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 433 266 9880

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 15526770003@163.com

研究实施负责（组长）单位：

延边大学附属医院（延边医院）

Primary sponsor：

Yanbian University Affiliated Hospital (Yanbian Hospital)

研究实施负责（组长）单位地址：

吉林省延吉市局子街1327号

Primary sponsor's address：

No. 1327, Bureau Street, Yanji City, Jilin Province, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东省

市(区县)：

广州市

Country：

China

Province：

Guangdong

City：

Guangzhou

单位(医院)：

广州喜鹊医药有限公司

具体地址：

广东省广州市黄埔区科学城揽月路80号广州科技创新基地F栋4楼

Institution
hospital：

Guangzhou Magpie Pharmaceuticals Co., Ltd

Address：

Building F, 4th Floor, Science & Technology Invovation Base, No.80 Lanyue Rd., Science City, Huangpu District, Guangzhou City, Guangdong Province, China

经费或物资来源：

广州喜鹊医药有限公司

Source(s) of funding：

Guangzhou Magpie Pharmaceutical Co., Ltd.

研究疾病：

肾功能不全  

Target disease：

Renal insufficiency

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

主要试验目的： 评估不同程度肾功能不全受试者及健康受试者单次口服硝酮嗪片，对硝酮嗪及其主要代谢产物药代动力学特征的影响。 次要试验目的： 评估单次口服硝酮嗪片在不同程度肾功能不全受试者、健康青中年受试者和健康老年受试者中的安全性及耐受性。  

Objectives of Study：

Primary Test Objective: To assess the effect of a single oral dose of TBN tablets on the pharmacokinetic profile of TBN and its major metabolites in subjects with varying degrees of renal insufficiency and in healthy subjects. Secondary Test Objective: To assess the safety and tolerability of a single oral dose of TBN tablets in subjects with varying degrees of renal insufficiency, healthy young to middle-aged subjects and healthy elderly subjects.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

以下标准适用于肾功能不全受试者（第1组 ~ 第3组）： 1.18 ~ 75周岁男性或女性受试者（含18和75周岁）； 2.基线期BMI ≥ 19 kg/m2且 ≤ 26 kg/m2，男性受试者体重≥50 kg，女性受试者体重≥45 kg； 3.诊断为肾功能不全，筛选期受试者肾功能损伤程度为：轻度肾功能不全（eGFR：60 ~ 89 mL/min/1.73m2，含边界值），或中度肾功能不全（eGFR：30 ~ 59 mL/min/1.73m2，含边界值），或重度肾功能不全（eGFR：15 ~ 29 mL/min/1.73m2，含边界值），eGFR的估算基于血清肌酐和血清胱抑素C的联合公式； 4.肾功能不全疾病进展稳定，即筛选前至少3个月无临床意义的疾病进展（依据受试者病史记录）； 5.入组前病史（6个月内）、生命体征、心电图、体格检查、实验室检查（血常规、血生化、凝血功能和尿常规）和试验相关的各项检查，经研究者判断受试者状态良好，可参加临床试验。例：受试者患有轻度的慢性并发症、退行性关节炎、糖尿病、高血压、高血脂等，可以纳入试验； 6.受试者在试验前对本试验知情且同意，并由受试者自愿签署知情同意书。 以下标准适用于健康青中年组（第4组）： 1.18 ~ 65周岁男性或女性受试者（含18和65周岁），且年龄在肾功能不全受试者平均年龄 ± 10岁范围内； 2.基线期BMI ≥ 19 kg/m2且 ≤ 26 kg/m2，且在肾功能不全受试者的±20%范围内，男性受试者体重≥50 kg，女性受试者体重≥45 kg； 3.肾功能正常（eGFR：90 ~ 130 mL/min/1.73m2，包含90 mL/min/1.73m2，不包含130 mL/min/1.73m2），eGFR的估算基于血清肌酐和血清胱抑素C的联合公式； 4.入组前病史（3个月内）、生命体征、心电图、体格检查、实验室检查（血常规、血生化、凝血功能和尿常规）及试验相关的各项检查正常或异常无临床意义者； 5.受试者在试验前对本试验知情且同意，并由受试者自愿签署知情同意书。 以下标准适用于健康老年组（第5组）： 1.年龄65-75周岁男性或女性受试者（不含65周岁，含75周岁）； 2.基线期BMI ≥ 19 kg/m2且 ≤ 26 kg/m2，男性受试者体重≥50 kg，女性受试者体重≥45 kg； 3.肾功能正常（eGFR：90 ~ 130 mL/min/1.73m2，包含90 mL/min/1.73m2，不包含130 mL/min/1.73m2），eGFR的估算基于血清肌酐和血清胱抑素C的联合公式； 4.入组前病史（3个月内）、生命体征、心电图、体格检查、实验室检查（血常规、血生化、凝血功能和尿常规）及试验相关的各项检查正常或异常无临床意义者； 5.受试者在试验前对本试验知情且同意，并由受试者自愿签署知情同意书。

Inclusion criteria

The following criteria apply to subjects with renal insufficiency (groups 1 to 3) : 1.Male or female subjects aged 18 to 75 years old (including 18 and 75 years old); 2.BMI >= 19 kg/m^2 and <= 26 kg/m^2 at baseline, body weight >=50 kg for male subjects and >=45 kg for female subjects; 3.Patients diagnosed with renal insufficiency had mild renal insufficiency (eGFR: 60 ~ 89 mL/min/1.73m^2, including boundary values) or moderate renal insufficiency (eGFR: 30 to 59mL/min/1.73m^2, including the boundary value), or severe renal insufficiency (eGFR: 15 to 29 mL/min/1.73m^2, including the boundary value), eGFR was estimated based on the combined formula of serum creatinine and serum cystatin C; 4. Stable progression of renal insufficiency, i.e., no clinically significant disease progression at least 3 months prior to screening (based on the subject's medical history); 5. Pre-enrollment medical history (within 6 months), vital signs, electrocardiogram, physical examination, laboratory examination (blood routine, blood biochemistry, coagulation function and urine routine) and various tests related to the test, the subjects were judged by the investigator to be in good condition and could participate in the clinical trial. Example: Subjects with mild chronic complications, degenerative arthritis, diabetes, hypertension, hyperlipidemia, etc., can be included in the trial; 6.The subject knows and agrees to the experiment before the experiment, and the subject signs the informed consent voluntarily. The following criteria apply to the healthy young and middle-aged group (Group 4) : 1. Male or female subjects aged 18 to 65 years old (including 18 and 65 years old), and the average age of subjects with renal dysfunction is within the range of +/- 10 years; 2.BMI >= 19 kg/m^2 and <= 26 kg/m^2 at baseline, and within the +/-20% range of subjects with renal insufficiency, body weight >=50 kg for male subjects and >=45 kg for female subjects; 3.Normal renal function (eGFR: 90 ~ 130 mL/min/1.73m^2, including 90 mL/min/1.73m^2, excluding 130 mL/min/1.73m^2), eGFR was estimated based on the combined formula of serum creatinine and serum cystatin C; 4.Pre-enrollment medical history (within 3 months), vital signs, electrocardiogram, physical examination, laboratory examination (blood routine, blood biochemistry, coagulation function and urine routine) and all tests related to the test were normal or abnormal without clinical significance; 5.The subject knows and agrees to the experiment before the experiment, and the subject signs the informed consent voluntarily. The following criteria apply to the healthy elderly group (Group 5) : 1.Male or female subjects aged 65-75 years (excluding 65 years old, including 75 years old); 2.BMI >= 19 kg/m^2 and <= 26 kg/m^2 at baseline, body weight >=50 kg for male subjects and >=45 kg for female subjects; 3.Normal renal function (eGFR: 90 ~ 130 mL/min/1.73m^2, including 90 mL/min/1.73m2, excluding 130 mL/min/1.73m^2), eGFR was estimated based on the combined formula of serum creatinine and serum cystatin C; 4.Pre-enrollment medical history (within 3 months), vital signs, electrocardiogram, physical examination, laboratory examination (blood routine, blood biochemistry, coagulation function and urine routine) and all tests related to the test were normal or abnormal without clinical significance; 5.The subject knows and agrees to the experiment before the experiment, and the subject signs the informed consent voluntarily·

排除标准：

以下标准适用于肾功能不全受试者（第1组 ~ 第3组）： 1.研究者判断（问诊）除肾功能不全外，现患有可能影响试验安全性或药物的体内代谢过程的疾病，包括但不限于：心脏、肝脏、消化道、免疫系统及呼吸系统等疾病，尤其是有任何影响药物吸收的胃肠道疾病（如肠易激综合征症状、肠病或炎症性肠病史），以及活动性病理性出血（如消化性溃疡）、荨麻疹、癫痫、过敏性鼻炎、湿疹性皮炎、哮喘等疾病； 2.诊断为记忆功能障碍、老年痴呆，或患精神类疾病，难以配合完成临床试验者； 3.受试者存在以下疾病：急性肾衰、肾病综合征、肾动脉狭窄或研究者认为风险较大的泌尿系统结石； 4.有肾移植病史或计划在试验期间进行肾移植； 5.筛选期出现肉眼血尿或结晶尿，且研究者认为有临床意义者； 6.筛选时肝功能检查结果异常（AST或ALT或ALKP ≥ 2倍ULN），或其它已知肝脏疾病，如肝硬化者； 7.筛选时传染病四项检查乙肝表面抗原（HBsAg）、丙肝抗体（HCV）、艾滋病（HIV）、梅毒（TP）其中一种或多种检测结果阳性，且研究者判断有临床意义者； 8.筛选前6个月内有药物滥用史或尿成瘾性筛查呈阳性者； 9.受试者正在服用已知会影响肾小管分泌和/或通过与转运体相互作用而重新吸收的药物（见禁用药物），并在试验期间不能停止服用这些药物； 10.既往对川芎嗪或试验药物辅料（甘露醇、羟丙纤维素、交联聚维酮、滑石粉、碳酸氢钠、硬脂酸镁、甲基丙烯酸-丙烯酸乙酯共聚物、枸橼酸三乙酯、二氧化钛）过敏者； 11.给药前3个月内注射疫苗者； 12.筛选前6个月内经常饮酒者，即每周饮酒超过14个单位的酒精（1单位=360 mL酒精含量为5%的啤酒，或45 mL酒精量为40%的烈酒，或150 mL酒精量为12%的葡萄酒），或不同意在给药前24 h及住院期间停止酒精摄入者，或酒精呼气测试阳性者； 13.不同意在给药前24 h及住院期间禁止摄入含咖啡因的食物或饮料（如咖啡、茶、巧克力和含咖啡因的碳酸饮料、可乐等）、西柚、西柚汁或含罂粟的食物； 14.筛选前3个月内吸烟量≥5支/天，且不能遵守试验期间的禁烟管理者； 15.给药前3个月内失血或献血超过200 mL者，或1个月内献血小板2个治疗量（1个治疗量=12 U血小板）； 16.正在接受另一种临床试验药物，或给药前3个月内使用过其他临床试验药物； 17.筛选前30天未采取有效的避孕措施，或试验期间不能采取有效的避孕措施，或受试者及其配偶在给药后6个月内有生育计划者，或受试者在给药后6个月内有捐精、捐卵计划者。血妊娠阳性、妊娠期或哺乳期女性受试者也应排除本试验； 18.存在研究者认为不适合参加本试验的其他情况。 以下标准适用于健康青中年组和健康老年组（第4组 ~ 第5组）： 1.现患有可能影响试验安全性或药物的体内代谢过程的疾病，包括但不限于：心脏、肝脏、消化道、免疫系统及呼吸系统等疾病，尤其是有任何影响药物吸收的胃肠道疾病（如肠易激综合征症状、肠病或炎症性肠病史）、活动性病理性出血（如消化性溃疡）、荨麻疹、癫痫、过敏性鼻炎、湿疹性皮炎、哮喘等； 2.诊断为记忆功能障碍，老年痴呆，或患精神类疾病，难以配合完成临床试验者； 3.既往对川芎嗪或试验药物辅料（甘露醇、羟丙纤维素、交联聚维酮、滑石粉、碳酸氢钠、硬脂酸镁、甲基丙烯酸-丙烯酸乙酯共聚物、枸橼酸三乙酯、二氧化钛）过敏者； 4.给药前14天内使用过任何药物者； 5.给药前3个月内注射疫苗者； 6.筛选时肝功能检查结果异常（AST或ALT或ALKP ≥ 2倍ULN），或其它已知肝脏疾病，如肝硬化者； 7.筛选时传染病四项检查乙肝表面抗原（HBsAg）、丙肝抗体（HCV）、艾滋病（HIV）、梅毒（TP）其中一种或多种检测结果阳性，且研究者判断有临床意义者； 8.筛选前6个月内有药物滥用史或尿成瘾性筛查呈阳性者； 9.筛选前6个月内经常饮酒者，即每周饮酒超过14个单位的酒精（1单位=360 mL酒精含量为5%的啤酒，或45 mL酒精量为40%的烈酒，或150 mL酒精量为12%的葡萄酒），或不同意在给药前24 h及住院期间停止酒精摄入者，或酒精呼气测试阳性者； 10.不同意在给药前24 h及住院期间禁止摄入含咖啡因的食物或饮料（如咖啡、茶、巧克力和含咖啡因的碳酸饮料、可乐等）、西柚、西柚汁或含罂粟的食物； 11.筛选前3个月内吸烟量≥5支/天，且不能遵守试验期间的禁烟管理者； 12.给药前3个月内失血或献血超过200 mL者，或1个月内献血小板2个治疗量（1个治疗量=12 U血小板）； 13.正在接受另一种临床试验药物，或给药前3个月内使用过其他临床试验药物； 14.筛选前30天未采取有效的避孕措施，或试验期间不能采取有效的避孕措施，或受试者及其配偶在给药后6个月内有生育计划者；或受试者在给药后6个月内有捐精、捐卵计划者。血妊娠阳性、妊娠期或哺乳期女性受试者也不应纳入本试验； 15.存在研究者认为不适合参加本试验的其他情况。

Exclusion criteria：

The following criteria apply to subjects with renal insufficiency (groups 1 to 3) : 1.The investigator determines that, in addition to renal insufficiency, there is a medical condition that may affect the safety of the trial or metabolic processes in the body of the drug, including but not limited to: Diseases of the heart, liver, digestive tract, immune system and respiratory system, especially any gastrointestinal diseases that affect the absorption of drugs (e.g. symptoms of irritable bowel syndrome, history of bowel disease or inflammatory bowel), as well as active pathological bleeding (e.g. peptic ulcer), urticaria, epilepsy, allergic rhinitis, eczematous dermatitis, asthma, etc.; 2. Patients diagnosed with memory dysfunction, Alzheimer's disease, or mental illness, who are difficult to cooperate with the completion of clinical trials; 3.The subjects had the following diseases: acute renal failure, nephrotic syndrome, renal artery stenosis, or urolithiasis considered by the researchers to be of greater risk; 4.Have a history of kidney transplantation or plan to undergo kidney transplantation during the trial; 5.Gross hematuria or crystalluria occurred during the screening period, and the researcher considered it clinically significant; 6.Abnormal liver function test results (AST or ALT or ALKP >= 2x ULN), or other known liver diseases, such as cirrhosis; 7.When screening for infectious diseases, one or more of the four tests for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), AIDS (HIV), syphilis (TP) were positive, and the investigator judged that there was clinical significance; 8.Patients with a history of drug abuse or positive urine addiction screening within 6 months before screening; 9.Subjects are taking drugs known to affect renal tubule secretion and/or reabsorption through interaction with transporters (see Prohibited drugs) and cannot stop taking these drugs during the trial; 10.Those allergic to ligustrazine or experimental drug excipients (mannitol, hydroxypropyl cellulose, crosslinked POvinone, talc powder, sodium bicarbonate, magnesium stearate, copolymer of methacrylate and ethyl acrylate, triethyl citrate, titanium dioxide) in the past; 11.Those who received the vaccine within 3 months before administration; 12.Regular drinkers in the six months prior to screening, i.e., those who drink more than 14 units of alcohol per week (1 unit =360 mL beer with 5% alcohol, or 45 mL spirits with 40% alcohol, or 150 mL wine with 12% alcohol), or who do not agree to stop alcohol intake 24 hours prior to administration and during hospitalization, Or positive for alcohol breath test; 13.do not agree to prohibit the consumption of caffeinated foods or beverages (such as coffee, tea, chocolate and caffeinated carbonated beverages, colas, etc.), grapefruit, grapefruit juice or foods containing opium poppy for 24 hours prior to administration and during hospitalization; 14.Smoking >=5 cigarettes/day in the 3 months before screening, and cannot comply with the anti-smoking manager during the test period; 15.Patients with blood loss or blood donation of more than 200 mL within 3 months before administration, or 2 therapeutic amounts of platelets within 1 month (1 therapeutic amount =12 U platelets); 16. is receiving another clinical trial drug, or has used another clinical trial drug within 3 months prior to administration; 17.No effective contraceptive measures were taken 30 days before screening, or no effective contraceptive measures could be taken during the trial, or the subject and his or her spouse had a birth plan within 6 months after dosing, or the subject had a sperm or egg donor plan within 6 months after dosing. Blood pregnancy positive, pregnant or lactating female subjects should also be excluded from this test; 18.There are other conditions that the investigator considers inappropriate to participate in this test. The following criteria are applicable to healthy young adults and healthy elderly adults (groups 4 to 5) : 1.Present medical conditions that may affect the safety of the trial or metabolic processes in the body of the drug, including but not limited to: Diseases of the heart, liver, digestive tract, immune system and respiratory system, especially any gastrointestinal diseases that affect drug absorption (e.g. symptoms of irritable bowel syndrome, history of bowel disease or inflammatory bowel), active pathological bleeding (e.g. peptic ulcer), urticaria, epilepsy, allergic rhinitis, eczematous dermatitis, asthma, etc.; 2.Patients diagnosed with memory dysfunction, Alzheimer's disease, or mental illness, who are difficult to cooperate with the completion of clinical trials; 3. Those allergic to ligustrazine or experimental drug excipients (mannitol, hydroxypropyl cellulose, crosslinked POvinone, talc powder, sodium bicarbonate, magnesium stearate, copolymer of methacrylate and ethyl acrylate, triethyl citrate, titanium dioxide) in the past; 4.Use of any drug within 14 days prior to administration; 5.Those who received the vaccine within 3 months before administration; 6.Abnormal liver function test results (AST or ALT or ALKP >= 2x ULN), or other known liver diseases, such as cirrhosis; 7.When screening for infectious diseases, one or more of the four tests for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), AIDS (HIV), syphilis (TP) were positive, and the investigator judged that there was clinical significance; 8.Patients with a history of drug abuse or positive urine addiction screening within 6 months before screening; 9.Regular drinkers in the six months prior to screening, i.e., those who drink more than 14 units of alcohol per week (1 unit =360 mL beer with 5% alcohol, or 45 mL spirits with 40% alcohol, or 150 mL wine with 12% alcohol), or who do not agree to stop alcohol intake 24 hours prior to administration and during hospitalization, Or positive for alcohol breath test; 10.do not agree to prohibit the consumption of caffeinated foods or beverages (such as coffee, tea, chocolate and caffeinated carbonated beverages, colas, etc.), grapefruit, grapefruit juice or foods containing opium poppy for 24 hours before administration and during hospitalization; 11. Smoking >=5 cigarettes/day in the 3 months before screening, and cannot comply with the anti-smoking manager during the test period; 12.Patients with blood loss or blood donation exceeding 200 mL within 3 months before administration, or 2 therapeutic amounts of platelets donated within 1 month (1 therapeutic amount =12 U platelets); 13.is receiving another clinical trial drug, or has used another clinical trial drug within 3 months prior to administration; 14.No effective contraception was used within 30 days prior to screening, or no effective contraception was available during the trial, or the subject and his or her spouse had a family plan within 6 months after dosing; Or the subject has a sperm donor or egg donor plan within 6 months after drug administration. Blood pregnancy positive, pregnant or lactating female subjects should not be included in this test; 15.There are other conditions that the investigator considers inappropriate for participation in this study.

研究实施时间：

Study execute time：

从 From 2022-09-01 00:00:00至 To 2025-09-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-08-24 00:00:00 至 To 2025-08-20 00:00:00

干预措施：

Interventions：

组别：

轻度肾功能不全组

样本量：

 8

Group：

Mild renal insufficiency group

Sample size：

干预措施：

600 mg硝酮嗪片

干预措施代码：

Intervention：

600 mg TBN tablets

Intervention code：

组别：

中度肾功能不全组

样本量：

 8

Group：

Moderate renal insufficiency group

Sample size：

干预措施：

600 mg硝酮嗪片

干预措施代码：

Intervention：

600 mg TBN tablets

Intervention code：

组别：

重度肾功能不全组

样本量：

 8

Group：

Severe renal insufficiency group

Sample size：

干预措施：

600 mg硝酮嗪片

干预措施代码：

Intervention：

600 mg TBN tablets

Intervention code：

组别：

健康青中年组

样本量：

 8

Group：

Healthy young and middle-aged group

Sample size：

干预措施：

600 mg硝酮嗪片

干预措施代码：

Intervention：

600 mg TBN tablets

Intervention code：

组别：

健康老年组

样本量：

 8

Group：

Healthy elderly group

Sample size：

干预措施：

600 mg硝酮嗪片

干预措施代码：

Intervention：

600 mg TBN tablets

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 吉林 

市(区县)：

 延吉 

Country：

China

Province：

Jilin

City：

Yanji

单位(医院)：

 延边大学附属医院（延边医院） 

单位级别：

 三级甲等 

Institution
hospital：

Yanbian University Hosipital (Yanbian Hospital)

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

药代动力学参数

指标类型：

主要指标

Outcome：

Pharmacokinetics parameters

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

服药后至试验结束期间发生严重不良反应的受试者比例

指标类型：

主要指标

Outcome：

Proportion of subjects experiencing serious adverse reactions between the time of dosing and the end of the trial.

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

服药后至试验结束期间发生不良反应的受试者比例

指标类型：

次要指标

Outcome：

Proportion of subjects experiencing adverse reactions between the time of dosing and the end of the trial.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

全血

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

尿液

组织：

Sample Name：

Urine

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

无

Randomization Procedure (please state who generates the random number sequence and by what method)：

NA

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Blinding：

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

试验6个月内公开完成后，登记在EDC系统上：http://oc.gzboji.com:8081/olsa/oc/rdcLogin.do?event=doSetup&mode=P

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

After the trial is publicly completed within six months,registered on the EDC: http://oc.gzboji.com:8081/olsa/oc/rdcLogin.do?event=doSetup&mode=P

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

采用电子采集和管理系统

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Using Electronic Data Capture

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-07-28 11:31:45