简体中文|English
检索试验 按国家、省（市）统计 按疾病代码统计 按试验实施单位统计 按试验主办单位统计 按经费或物资来源统计 按征募研究对象情况统计 按注册状态统计 按干预措施统计 按伦理委员会统计 按研究类型统计
一项评价注射用盐酸兰地洛尔在中国健康试验参与者中的药代动力学研究
下载XML文档

注册号：

Registration number：

 ChiCTR2600121841 

最近更新日期：

Date of Last Refreshed on：

 2026-04-03 17:30:54 

注册时间：

Date of Registration：

 2026-04-03 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一项评价注射用盐酸兰地洛尔在中国健康试验参与者中的药代动力学研究

Public title：

A Pharmacokinetic Study of Landiolol Hydrochloride for Injection in Chinese Healthy Participants

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一项评价注射用盐酸兰地洛尔在中国健康试验参与者中的药代动力学研究

Scientific title：

A Pharmacokinetic Study of Landiolol Hydrochloride for Injection in Chinese Healthy Participants

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：

黄洁 

研究负责人：

阳国平 

Applicant：

Huang Jie 

Study leader：

Yang Guoping 

申请注册联系人电话：

Applicant telephone：

 +86 731 8991 8665

研究负责人电话：

Study leader's
telephone：

+86 731 8991 8938

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：

 cellahuang1988@163.com

研究负责人电子邮件：

Study leader's E-mail：

 ygp9880@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：

中国湖南省长沙市岳麓区桐梓坡路138号

研究负责人通讯地址：

中国湖南省长沙市岳麓区桐梓坡路138号

Applicant address：

No. 138 Tongzipo Road, Yuelu District, Changsha City, Hunan Province, China

Study leader's address：

No. 138 Tongzipo Road, Yuelu District, Changsha City, Hunan Province, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

中南大学湘雅三医院临床试验研究中心

Applicant's institution：

Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University

研究负责人所在单位：

中南大学湘雅三医院临床试验研究中心

Affiliation of the Leader：

Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University

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：

 26068

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：

中南大学湘雅三医院伦理委员会

Name of the ethic committee：

IRB,theThird Xiangya Hospital of Central South University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-03-17 00:00:00

伦理委员会联系人：

王晓敏

Contact Name of the ethic committee：

Wang Xiaomin

伦理委员会联系地址：

湖南省长沙市岳麓区桐梓坡路138号中南大学湘雅三医院伦理委员会

Contact Address of the ethic committee：

IRB,theThird Xiangya Hospital of Central South University,138 Tongzipo Road,Yuelu District,Changsha,Hunan,China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 731 8861 8938

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

中南大学湘雅三医院临床试验中心

Primary sponsor：

Clinical Trial Center of Third Xiangya Hospital of Central South University

研究实施负责（组长）单位地址：

中国湖南省长沙市岳麓区桐梓坡路138号

Primary sponsor's address：

No. 138 Tongzipo Road, Yuelu District, Changsha City, Hunan 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)：

湖南

市(区县)：

Country：

China

Province：

Hunan

City：

单位(医院)：

中南大学湘雅三医院

具体地址：

湖南省长沙市岳麓区桐梓坡路138号

Institution
hospital：

Third Xiangya Hospital, Central South Univer

Address：

138 Tongzipo Road,Yuelu District,Changsha,Hunan,China

经费或物资来源：

中山万汉制药有限公司

Source(s) of funding：

Zhongshan Wanhan Pharmaceutical Co., Ltd.

研究疾病：

快速性心律失常  

Target disease：

Tachyarrhythmias

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：

 其它 

Study phase：

N/A

研究设计：

单臂 

Study design：

Single arm 

研究目的：

主要研究目的：本研究考察空腹条件下使用由中山万汉制药有限公司生产的注射用盐酸兰地洛尔在中国健康试验参与者体内的药动学特征。 次要研究目的：观察中山万汉制药有限公司生产的注射用盐酸兰地洛尔在中国健康试验参与者中的安全性。  

Objectives of Study：

Primary Objective:This study investigates the pharmacokinetic characteristics of landiolol hydrochloride for injection manufactured by Zhongshan Wanhan Pharmaceutical Co., Ltd. in Chinese healthy participants under fasting conditions. Secondary Objective:To evaluate the safety of landiolol hydrochloride for injection manufactured by Zhongshan Wanhan Pharmaceutical Co., Ltd. in Chinese healthy participants.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

1.经病史询问、体格检查、生命体征检查（血压、体温、脉搏）及血常规、血生化、尿常规、12-导联心电图、凝血功能、乙肝表面抗原（HBs-Ag）、人免疫缺陷病毒抗原抗体、丙型肝炎抗体和梅毒螺旋体抗体等检查异常且具有临床意义者； 2.筛选期心率<60次/分或舒张压＜60mmHg或收缩压＜90mmHg者； 3.（筛选期/入住问诊）既往有低血压病史者； 4.（筛选期/入住问诊）既往有支气管痉挛病史者； 5.（筛选期/入住问诊）既往有循环系统疾病病史者：如冠心病、不稳定性心绞痛、急性心肌梗塞、充血性心力衰竭者、肺动脉高压引起的心功能不全、心源性休克、合并II度以上房室传导阻滞、病态窦房结综合征等过缓型心律失常，或末梢循环障碍（如坏疽、雷诺综合征、间歇性跛行等）； 6.（筛选期/入住问诊）既往存在内分泌系统疾病，如：糖尿病酮症、甲亢、代谢性酸中毒者； 7.（筛选期/入住问诊）有心、肝、肾、内分泌、消化道、血液系统、呼吸系统、免疫系统、神经系统精神疾病严重病史或慢性病病史或现有上述系统疾病者； 8.（筛选期/入住问诊）入住前两周内曾使用过任何药物（包括处方药、非处方药、维生素补充剂或中草药）、保健品者； 9.（筛选期/入住问诊）入住前2周内接种疫苗或试验期间计划接种疫苗者； 10.（筛选期问诊）已知对兰地洛尔等β1受体阻滞剂药物过敏或禁忌者； 11.（筛选期/入住问诊）既往有药物滥用史或一年内使用过毒品者； 12.（筛选期/入住问诊）试验首次给药前3个月内平均每日吸烟量多于5支，或试验期间不能停止使用任何烟草类产品者（含尼古丁制品）； 13.（筛选期/入住问诊）试验首次给药前6个月内经常饮酒者，即每周饮酒超过14单位酒精（1单位等于17.5mL或14g纯酒精，不同品种酒类酒精含量以体积比标示，1个酒精单位约等于50°白酒35mL或5°啤酒350mL），或整个试验期间不愿意停止饮酒或食用任何含酒精的制品者； 14.（筛选期/入住问诊+联网筛查）入住前3个月内参加过任何药物临床试验并使用了试验药物者； 15.（筛选期/入住问诊）入住前6个月内接受过任何外科手术或试验期间计划手术者； 16.（筛选期问诊）不能接受静脉穿刺，有晕针晕血史者； 17.（筛选期/入住问诊）入住前3个月内献血或失血400mL及以上者或计划在研究期间献血或血液成分者； 18.（筛选期/入住问诊）入住前3个月内每天饮用过量茶、咖啡或含咖啡因的饮料（8杯以上，1杯=250mL）者； 19.（筛选期/入住问诊）在首次服用研究药物前48小时内，吃过葡萄柚等影响代谢酶的水果或相关食品；或摄取了任何含咖啡因、罂粟或富含黄嘌呤成分的食物或饮料（如咖啡、浓茶、巧克力、可乐等）者；或不同意在试验期间避免食用上列食物或饮料，或避免剧烈运动者； 20.（筛选期/入住问诊）给药前30天内使用过任何改变肝酶活性的药物（如：诱导剂—巴比妥类、卡马西平、苯妥英、糖皮质激素；抑制剂—SSRI类抗抑郁药、西咪替丁、地尔硫卓、大环内酯类、硝基咪唑类、镇静催眠药、维拉帕米、氟喹诺酮类、抗组胺类、奥美拉唑）者；或给药前30天内使用过对交感神经有抑制作用的其他药物（利血平等）、钙拮抗剂（维拉帕米、地尔硫卓等）、洋地黄类药物、Ⅰ型抗心律失常药（丙吡胺、普鲁卡因胺等）、III型抗心律失常药（胺碘酮、尼非卡兰等）、枸橼酸芬太尼、丙泊酚等影响心脏传导功能的药物者； 21.呼气酒精测试结果大于0mg/100mL，尿液多项毒品联合检测呈阳性； 22.（筛选期/入住问诊）妊娠检查阳性或处于哺乳期的女性试验参与者；给药前2周内有无保护措施的性行为的女性试验参与者。试验首次给药前30天内使用口服避孕药，或试验首次给药前6个月内使用过长效雌激素或孕激素注射剂或埋植片者； 23.（筛选期/入住问诊）男性试验参与者（或其伴侣）或女性试验参与者自签署知情同意书开始3个月内有生育计划，或不能或不愿意按照研究者的指导在研究期间采取研究者认可的避孕措施者； 24.（筛选期问诊）不能遵守统一饮食者； 25. 试验参与者依从性不佳或因个人原因无法遵守研究方案的相关规定，研究者判断不适合参加本临床研究的试验参与者。

Exclusion criteria：

1.The patient has clinical significance due to abnormal medical history inquiry, physical examination, vital signs examination (blood pressure, body temperature, pulse), blood routine, blood biochemistry, urine routine, 12- lead electrocardiogram, blood coagulation function, hepatitis B surface antigen (HBs-Ag), human immunodeficiency virus antigen antibody, hepatitis C antibody and Treponema pallidum antibody; 2. heart rate < 60 beats/min, diastolic blood pressure < <60mmHg or systolic blood pressure < <90mmHg in the screening period; 3.(screening period/check-in) Those with previous history of hypotension; 4. (screening period/check-in) Those with previous history of bronchospasm; 5. (Screening period/check-in) Persons with previous history of circulatory diseases: such as coronary heart disease, unstable angina pectoris, acute myocardial infarction, congestive heart failure, cardiac insufficiency caused by pulmonary hypertension, cardiogenic shock, bradycardia such as atrioventricular block with degree II or above, sick sinus syndrome, or peripheral circulatory disorders (such as gangrene, Raynaud's syndrome, intermittent claudication, etc.); 6. (screening period/check-in) Persons with previous endocrine system diseases, such as diabetic ketosis, hyperthyroidism and metabolic acidosis; 7. (screening period/check-in) Those who have a serious history of mental illness or chronic disease of heart, liver, kidney, endocrine, digestive tract, blood system, respiratory system, immune system and nervous system or have the above-mentioned system diseases; 8. (screening period/check-in consultation) Those who have used any drugs (including prescription drugs, over-the-counter drugs, vitamin supplements or Chinese herbal medicines) and health products within two weeks before check-in; 9. (screening period/check-in consultation) Those who were vaccinated within 2 weeks before check-in or planned to be vaccinated during the trial period; 10. (consultation during the screening period) Those who are known to be allergic or contraindicated to β1 receptor blockers such as Landirol; 11. (screening period/check-in) Those who have a history of drug abuse or used drugs within one year; 12. (screening period/check-in) Those who smoke more than 5 cigarettes a day on average in the three months before the first drug administration in the trial, or who cannot stop using any tobacco products (nicotine-containing products) during the trial; 13. (screening period/check-in) Those who regularly drank alcohol within 6 months before the first administration in the trial, that is, those who drank more than 14 units of alcohol per week (1 unit is equal to 17.5mL or 14g pure alcohol, and the alcohol content of different varieties is marked by volume ratio, and 1 alcohol unit is equal to 35mL of 50-degree white wine or 350mL of 5-degree beer), or those who are unwilling to stop drinking or eat any alcoholic products during the whole trial; 14. (screening period/check-in consultation+online screening) Those who have participated in any drug clinical trials and used the experimental drugs within 3 months before check-in; 15. (screening period/check-in consultation) Those who have received any surgery or planned surgery during the trial within 6 months before check-in; 16. (screening consultation) those who can't accept venipuncture and have a history of needle fainting and blood fainting; 17. (screening period/check-in consultation) Those who have donated blood or lost 400mL or more within 3 months before check-in or plan to donate blood or blood components during the study period; 18. (screening period/check-in consultation) Those who drink too much tea, coffee or caffeinated drinks (more than 8 cups, 1 cup =250mL) every day within 3 months before check-in; 19. (screening period/check-in consultation) Have eaten grapefruit and other fruits or related foods that affect metabolic enzymes within 48 hours before taking the study drug for the first time; Or ingesting any food or beverage (such as coffee, strong tea, chocolate, cola, etc.) containing caffeine, poppy or xanthine; Or do not agree to avoid eating the above foods or drinks or avoid strenuous exercise during the experiment; 20. (screening period/check-in) Any drugs that change the activity of liver enzymes have been used within 30 days before administration (such as: inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids; Inhibitors-—SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines and omeprazole); Or those who have used other drugs (reserpine, etc.), calcium antagonists (verapamil, diltiazem, etc.), digitalis drugs, type I antiarrhythmic drugs (propyramide, procainamide, etc.), type III antiarrhythmic drugs (amiodarone, nifekalan, etc.), fentanyl citrate, propofol and other drugs that affect cardiac conduction function within 30 days before administration; 21. The breath alcohol test result is greater than 0mg/100mL, and the urine is positive for multiple drugs; 22. (screening period/check-in) Female trial participants with positive pregnancy test or lactation period; Female participants who had unprotected sex within 2 weeks before administration. Oral contraceptives were used within 30 days before the first administration in the trial, or long-acting estrogen or progesterone injections or implants were used within 6 months before the first administration in the trial; 23. (Screening period/check-in) Male participants (or their partners) or female participants have a birth plan within 3 months after signing the informed consent form, or are unable or unwilling to take contraceptive measures approved by the researcher during the study period according to the guidance of the researcher; 24. (consultation during screening period) those who can't follow the unified diet; 25.The participants in the trial have poor compliance or are unable to comply with the relevant provisions of the research plan for personal reasons, and the researchers judge that they are not suitable for participating in this clinical study.

研究实施时间：

Study execute time：

从 From 2026-03-15 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-04-04 00:00:00 至 To 2026-04-10 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 12

Group：

Experimental group

Sample size：

干预措施：

在D1天试验参与者空腹以0.125mg/kg/min的速度静脉内给药1分钟，然后调节速度为0.04mg/kg/min静脉内持续给药10min。

干预措施代码：

Intervention：

On Day D1, trial participants were administered intravenously at a rate of 0.125 mg/kg/min for 1 minute while fasting, followed by adjustment of the rate to 0.04 mg/kg/min for continuous intravenous administration for 10 minutes.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖南 

市(区县)：

  

Country：

China

Province：

Hunan

City：

单位(医院)：

 中南大学湘雅三医院 

单位级别：

 三甲 

Institution
hospital：

The Third Xiangya Hospital of Central South University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

12-导联心电图指标

指标类型：

次要指标

Outcome：

12-lead electrocardiogram indicators

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

生命体征

指标类型：

次要指标

Outcome：

Vital signs

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

心电监护

指标类型：

次要指标

Outcome：

Electrocardiographic monitoring

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

药代动力学

指标类型：

主要指标

Outcome：

Pharmacokinetic

Type：

Primary 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：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 45 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)：

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

无

Blinding：

None

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

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）：

无

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

None

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：

数据采集：由研究者或其授权的CRC通过独立的账号进入数据管理系统，进行数据采集。 数据管理：数据管理员根据方案设计eCRF，eCRF中包含除外部数据外方案中规定的全部数据点。由EDC系统直接导出eCRF（PDF格式）。

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

Data collection: Researchers or their authorized clinical research coordinators (CRCs) access the data management system through independent accounts to conduct data collection. Data management: Data managers design the electronic case report forms (eCRF) according to the protocol. The eCRF contains all the data points specified in the protocol except for external data. The eCRF (in PDF format) is directly exported from the Electronic Data Capture (EDC) system.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-04-03 17:30:43
返回列表
欢迎访问WHO国际临床试验注册平台 Clinical Trials Hong Kong

中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

Copyright(c) (2005 - 2023) Chictr.org.cn.All rights reserved. 中国临床试验注册中心 版权所有

蜀ICP备16010396号-9

提示：推荐使用IE8.0以上版本 宽屏显示分辨率下使用系统