ChiCTR2300068276 版本V1.0 版本创建时间2023/02/13 16:26:04 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：

 ChiCTR2300068276 

最近更新日期：

Date of Last Refreshed on：

 2023-02-13 16:25:49 

注册时间：

Date of Registration：

 2023-02-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

氨氯地平贝那普利胶囊在健康受试者中的药代动力学研究

Public title：

Pharmacokinetic study of amlodipine benazepril capsules in healthy subjects

注册题目简写：

English Acronym：

研究课题的正式科学名称：

氨氯地平贝那普利胶囊在健康受试者中的药代动力学研究

Scientific title：

Pharmacokinetic study of amlodipine benazepril capsules in 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：

张美琳 

研究负责人：

阳国平 

Applicant：

Meilin Zhang 

Study leader：

Guoping Yang 

申请注册联系人电话：

Applicant telephone：

 18723596158

研究负责人电话：

Study leader's
telephone：

0731-89918665

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：

 zhangmeilin69@163.com

研究负责人电子邮件：

Study leader's E-mail：

 ygp9880@163.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：

长沙市岳麓区桐梓坡路138号

研究负责人通讯地址：

长沙市岳麓区桐梓坡路138号

Applicant address：

138 Tongzibo Road, Yuelu District, Changsha City, Hunan Province

Study leader's address：

138 Tongzibo Road, Yuelu District, Changsha City, Hunan Province

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：

 410013

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 of 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 of 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：

 22126

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：

The IRB of the Third Xiangya Hospital of Central South University

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-10-20 00:00:00

伦理委员会联系人：

王晓敏

Contact Name of the ethic committee：

Xiaomin Wang

伦理委员会联系地址：

湖南省长沙市岳麓区桐梓坡路138号

Contact Address of the ethic committee：

138 Tongzibo Road, Yuelu District, Changsha City, Hunan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 0731-88618938

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：

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

研究实施负责（组长）单位地址：

长沙市岳麓区桐梓坡路138号

Primary sponsor's address：

138 Tongzibo Road, Yuelu District, Changsha City, Hunan Province

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)：

长沙

Country：

China

Province：

Hunan

City：

Changsha

单位(医院)：

中南大学湘雅三医院临床试验中心

具体地址：

湖南省长沙市岳麓区桐梓坡路138号

Institution
hospital：

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

Address：

138 Tongzibo Road, Yuelu District, Changsha, Hunan

经费或物资来源：

成都倍特药业股份有限公司

Source(s) of funding：

Brilliant Pharmaceuticals

研究疾病：

高血压病  

Target disease：

High blood pressure disease

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：

随机交叉对照 

Study design：

Cross-over 

研究目的：

主要研究目的：本研究以成都倍特药业股份有限公司生产的氨氯地平贝那普利胶囊（氨氯地平 5mg；盐酸贝那普利 10mg）为受试制剂，原研诺华制药（Novartis Pharmaceuticals Corp）生产的氨氯地平贝那普利胶囊（氨氯地平 5mg；盐酸贝那普利10mg，商品名：Lotrel ?）为参比制剂，评价受试制剂和参比制剂在空腹和餐后条件下给药时的药代动力学相似性。 次要研究目的：观察受试制剂和参比制剂在健康受试者中的安全性。  

Objectives of Study：

The main objective of the study was to evaluate the pharmacokinetic similarity between the test formulation and the reference formulation when administered under fasting and postprandial conditions using amlodipine benazepril capsules (amlodipine 5mg; benazepril hydrochloride 10mg) manufactured by Chengdu Bite Pharmaceuticals Co. To evaluate the pharmacokinetic similarity between the test formulation and the reference formulation when administered under fasting and postprandial conditions. Secondary study objective: To observe the safety of the test and reference formulations in healthy subjects.

药物成份或治疗方案详述：

氨氯地平贝那普利胶囊 主要成份苯磺酸氨氯地平及盐酸贝那普利 

Description for medicine or protocol of treatment in detail：

Amlodipine Besylate and Benazepril Hydrochloride Capsul Main ingredients amlodipine besylate and benazepril hydrochloride 

纳入标准：

受试者必须同时满足以下所有选项：1） 性别：男性或女性健康受试者；2） 年龄：18~65 周岁（包括边界值）3） 体重：男性受试者不应低于 50.0kg，女性受试者不应低于 45.0kg，身体质量指数【BMI=体重（kg）/身高 2（m2）】在 19.0～28.0kg/m2 范围内（包括边界值）；4） 受试者必须在试验前对本研究知情同意，并自愿签署书面的知情同意书；5） 受试者能够与研究者作良好的沟通并能够依照研究规定完成研究。

Inclusion criteria

Subjects must meet all of the following options: 1) Gender: male or female healthy subjects; 2) Age: 18 to 65 years old (including borderline values); 3) Weight: male subjects should not be less than 50.0 kg and female subjects should not be less than 45.0 kg, with a body mass index [BMI = weight (kg)/height 2 (m2)] in the range of 19.0 to 28.0 kg/m2 (including borderline values); 4) Subjects must have given informed consent to the study prior to the trial and voluntarily signed a written informed consent form; 5) Subjects were able to communicate well with the investigator and were able to complete the study in accordance with the study regulations.

排除标准：

凡是出现下列情况之一者不能入选本试验：1) 既往或目前正患有循环系统、内分泌系统、神经系统、消化系统、呼吸系统、泌尿生殖系统、血液学、免疫学、精神病学及代谢异常等任何临床严重疾病者或能干扰试验结果的任何其他疾病；2) 有药物、食物或其他物质过敏史；3) 试验前 6 个月内接受过外科手术，或计划在研究期间进行外科手术者；4) 试验前 14 天内服用过任何药物或保健品（包括中草药）；5) 试验前 30 天内使用过任何抑制或诱导肝脏对药物代谢的药物（如：诱导剂—巴比妥类、卡马西平、苯妥英、糖皮质激素、奥美拉唑；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）者；6) 试验前 3 个月内参加任何临床试验且服用了任何临床试验药物者；7) 在入选前 3 个月内献血或大量失血（≥200 mL，不包括女性月经期失血）、接受输血或使用血制品者；8) 妊娠或哺乳期妇女，以及志愿者试验期间不能采用一种或一种以上的非药物避孕措施者；9) 对饮食有特殊要求，不能遵守统一饮食者；10) 每天饮用过量茶、咖啡和/或含咖啡因的饮料（8 杯以上，1 杯=250 mL）者；11) 嗜烟者或试验前 3 个月每日吸烟量多于 5 支者或试验期间不能停止使用任何烟草类产品者；12) 酗酒者或试验前 6 个月内经常饮酒者，即每周饮酒超过 14 单位酒精（1 单位=360 mL 啤酒或 45 mL 酒精量为 40%的烈酒或 150 mL 葡萄酒）或试验期间不能停止使用任何含酒精产品者；13) 药物滥用者或试验前 3 个月使用过软毒品（如：大麻）或试验前 1 年服用硬
毒品（如：可卡因、苯环己哌啶等）者；14) 生命体征异常者（收缩压<90 mmHg 或>140 mmHg，舒张压<60 mmHg 或>90mmHg；心率<50 bpm 或>100 bpm）或体格检查、心电图、实验室检查异常有临床意义（以临床研究医生判断为准）；15） 志愿者可能因为其他原因而不能完成本研究或研究者认为不应纳入者。16） 有吞咽困难者17） 不能耐受静脉穿刺者，有晕针晕血史者；18） 首次给药前 28 天内曾接种过新型冠状病毒疫苗，或计划在研究过程中接种新型冠状病毒疫苗者。19） 乙肝表面抗原、丙肝抗体、梅毒螺旋体抗体（TP-trust）或艾滋病病毒抗体检查结果异常有临床意义者；20） 研究首次用药前 48 小时内，摄入过任何富含葡萄柚成份或其他影响药物吸收、分布、代谢、排泄等的饮料或食物者；

Exclusion criteria：

Anyone who has any of the following conditions cannot be enrolled in this trial: 1) Anyone who has had or is currently suffering from any clinically serious disease such as circulatory, endocrine, neurological, digestive, respiratory, genitourinary, hematological, immunological, psychiatric and metabolic abnormalities or any other disease that can interfere with the test results; 2) Any history of drug, food or other substance allergy; 3) Anyone who has undergone any surgical procedure within 6 months prior to the trial 4) have taken any medications or supplements (including herbal medicines) within 14 days prior to the trial; 5) have used any drugs that inhibit or induce hepatic metabolism of drugs (e.g., inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors -SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines); 6) those who participated in any clinical trial and took any clinical trial drug within 3 months prior to the trial; 7) those who donated blood or lost a significant amount of blood (≥200 mL, excluding women) within 3 months prior to enrollment blood loss during menstruation), receipt of blood transfusion or use of blood products within the 3 months prior to enrollment; 8) pregnant or lactating women and those who are unable to use one or more non-pharmaceutical contraceptive measures during the volunteer trial; 9) those with special dietary requirements who are unable to comply with a uniform diet; 10) those who consume excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day.11) Tobacco users or those who smoked more than 5 cigarettes per day in the 3 months prior to the trial or were unable to stop using any tobacco products during the trial; 12) Alcoholics or those who were regular drinkers in the 6 months prior to the trial, i.e., consumed more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcoholic spirits or 150 mL of wine) or were unable to stop using any alcoholic products during the trial; 13) Substance abusers or those who used soft drugs (e.g., marijuana) in the 3 months prior to the trial or took hard drugs in the 1 year prior to the trial soft drugs (e.g., marijuana) 3 months prior to the trial or hard drugs (e.g., cocaine, benzine) 1 year prior to the trial
(e.g., cocaine, phencyclidine, etc.) in the year prior to the trial; 14) abnormal vital signs (systolic blood pressure <90 mmHg or >140 mmHg, diastolic blood pressure <60 mmHg or >90 mmHg; heart rate <50 bpm or >100 bpm) or clinically significant abnormalities in physical examination, electrocardiogram, or laboratory tests (as determined by the clinician); 15) volunteers who may not be able to complete the study for other reasons or who, in the opinion of the investigator, should not be included. (15) Volunteers who may be unable to complete the study for other reasons or who, in the opinion of the investigator, should not be included.16) Those who have difficulty swallowing.17) Those who cannot tolerate venipuncture, or who have a history of dizziness from needles or blood; 18) Those who have received a novel coronavirus vaccine within 28 days prior to the first dose, or who plan to receive a novel coronavirus vaccine during the study.19) Those who have abnormal results of hepatitis B surface antigen, hepatitis C antibody, syphilis spirochete antibody (TP-trust), or HIV antibody tests Those with clinically significant abnormal results;20) Those who have ingested any beverage or food rich in grapefruit or other ingredients that interfere with the absorption, distribution, metabolism, excretion, etc. of the drug within 48 hours prior to the first dose of the study;

研究实施时间：

Study execute time：

从 From 2023-02-12 00:00:00至 To 2026-02-12 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-02-14 00:00:00 至 To 2026-02-14 00:00:00

干预措施：

Interventions：

组别：

A

样本量：

 6

Group：

A

Sample size：

干预措施：

空腹组 12 例受试者按照 筛选先后顺序随机分配至 A、B 组，每组 6 例，A 组的给药顺序为T、R

干预措施代码：

Intervention：

The 12 subjects in the fasting group were randomly assigned to groups A and B according to Group A was randomly assigned to groups A and B, with 6 subjects in each group, and the order of administration in group A was T, R

Intervention code：

组别：

B

样本量：

 6

Group：

B

Sample size：

干预措施：

空腹组 12 例受试者按照 筛选先后顺序随机分配至 A、B 组，每组6例，B组的给药顺序为R、T；

干预措施代码：

Intervention：

The 12 subjects in the fasting group were randomly assigned to groups A and B in the order of screening, with 6 subjects in each group and the order of administration in group B being R and T

Intervention code：

组别：

C

样本量：

 6

Group：

C

Sample size：

干预措施：

餐后组 12 例受试者按照筛选先后顺序随机分配至 C 组或 D 组，每组 6 例， C 组的给药顺序为T、R，

干预措施代码：

Intervention：

The 12 subjects in the postprandial group were randomly assigned to either Group C or Group D in the order of screening, with 6 subjects in each group, and the order of administration in Group C was T and R.

Intervention code：

组别：

D

样本量：

 6

Group：

D

Sample size：

干预措施：

餐后组 12 例受试者按照筛选先后顺序随机分配至 C 组或 D 组，每组 6 例，D 组的给药顺序为 R、T。

干预措施代码：

Intervention：

The 12 subjects in the postprandial group were randomly assigned to either Group C or Group D in the order of screening, with 6 subjects in each group and the order of administration in Group D being R and T.

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)：

 长沙 

Country：

China

Province：

Hunan

City：

Changsha

单位(医院)：

 中南大学湘雅三医院临床试验中心 

单位级别：

 三级甲等 

Institution
hospital：

Clinical Trial Center of the Third Xiangya Hospital of Central South University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

生命体征

指标类型：

主要指标

Outcome：

Vital signs

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

体格检查

指标类型：

主要指标

Outcome：

Physical Examination

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

实验室检查

指标类型：

主要指标

Outcome：

Laboratory tests

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血药浓度

指标类型：

主要指标

Outcome：

Blood concentration

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不良事件

指标类型：

主要指标

Outcome：

Adverse Events

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

 使用后销毁  

说明

Fate of sample：

Destruction 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 65 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）：

随机表使用SAS 9.4（或以上版本）统计学软件、Microsoft Excel 或 SPSS 产生，根据受试者的随机号进行随机分组，在本研究中的每名受试者接受受试制剂或参比制剂的顺序（A 组、B 组、C 组、D 组）将由随机表确定。

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

The randomization table was generated using SAS 9.4 (or higher) statistical software, Microsoft Excel or SPSS, and subjects were randomly grouped according to their randomization number. The order in which each subject in this study received the test preparation or reference preparation (Group A, Group B, Group

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

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）：

发表文章

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

Published Articles

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：

数据管理计划（DMP): DMP 作为数据管理的指导性文件由数据管理员(DM ）撰写，申办方批准，数据管理工作将根据 DMP 定义的时间、内容及方法进行。 电子病例报告表（eCRF)：数据管理员根据试验方案设计构建，并根据逻辑核查计划（DVP ）设置逻辑核查，通过测试并获申办方批准后发布使用。 数据录入： eCRF 数据来源于原始记录，由数据录入人员根据 cCRF 填写说明，将受试者访视数据及时录入 EDC。 源数据现场核査(SDV)：监查员进行 cCRF 数据与源数据的一致性核对，有问题可发疑问。

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

Data Management Plan (DMP): The DMP is written by the Data Steward (DM) as a guidance document for data management and approved by the sponsor, and the data management will be carried out according to the time, content and methodology defined by the DMP. Electronic Medical Case Report Form (eCRF): The data manager builds according to the trial protocol design and sets up logical checks according to the Logic Review Plan (DVP), which is tested and approved by the sponsor before being released for use. Data entry: The eCRF data is derived from the original record, and the data entry personnel enter the subject event data into the EDC in a timely manner according to the cCRF filling instructions. Source Data On-Site Audit (SDV): Auditors check the consistency of cCRF data with source data, and ask questions if you have questions.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-02-13 16:25:49