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Clinical study of Xinyang tablet in healthy volunteers under fasting condition

注册号：

Registration number：

ITMCTR2000003067

最近更新日期：

Date of Last Refreshed on：

2020-02-29

注册时间：

Date of Registration：

2020-02-29

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

心阳片在健康志愿者空腹条件下体内暴露物质临床研究

Public title：

Clinical study of Xinyang tablet in healthy volunteers under fasting condition

注册题目简写：

English Acronym：

研究课题的正式科学名称：

心阳片在健康志愿者空腹条件下体内暴露物质临床研究

Scientific title：

Clinical study of Xinyang tablet in healthy volunteers under fasting condition

研究课题的正式科学名称简写：

Scientific title acronym：

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：

ChiCTR2000030369 ; ChiMCTR2000003067

申请注册联系人：

袁天慧

研究负责人：

冼绍祥、杨忠奇

Applicant：

Tian-Hui Yuan

Study leader：

Shao-xiang Xian, Zhong-qi Yang

申请注册联系人电话：

Applicant telephone：

+86 18666085946

研究负责人电话：

Study leader's telephone：

+86 13922738328

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：

katharinehui@163.com

研究负责人电子邮件：

Study leader's E-mail：

shaoxiangx@hotmail.com

申请单位网址(自愿提供)：

Study leader's 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：

广东省广州市白云区机场路12号

研究负责人通讯地址：

广东省广州市白云区机场路12号

Applicant address：

12 Jichang Road, Baiyun District, Guangzhou, Guangdong, China

Study leader's address：

12 Jichang Road, Baiyun District, Guangzhou, Guangdong, 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：

广州中医药大学第一附属医院

Applicant's institution：

The First Affiliated Hospital of Guangzhou University of traditional Chinese Medicine

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

ZYYECK（2020）005

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

广州中医药大学第一附属医院伦理委员会

Name of the ethic committee：

Ethics Committee of the First Affiliated Hospital of Guangzhou University of traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2020/2/19 0:00:00

伦理委员会联系人：

黎欣盈

Contact Name of the ethic committee：

Xin Ying Li

伦理委员会联系地址：

广州中医药大学第一附属医院办公楼501室

Contact Address of the ethic committee：

Room 501, office building, the First Affiliated Hospital of Guangzhou University of traditional Chinese Medicine, 12 Jichang Road, Baiyun District, Guangzhou, Guangdong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 020-36591965; 020-36588667

伦理委员会联系人邮箱：

Contact email of the ethic committee：

gztcmlunli@163.com

研究实施负责（组长）单位：

广州中医药大学第一附属医院

Primary sponsor：

The First Affiliated Hospital of Guangzhou University of traditional Chinese Medicine

研究实施负责（组长）单位地址：

广东省广州市白云区机场路12号

Primary sponsor's address：

12 Airport Road, Baiyun District, Guangzhou, Guangdong, 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)：

广州市白云区

Country：

China

Province：

Guangdong Province

City：

Baiyun District, Guangzhou

单位(医院)：

广州中医药大学第一附属医院

具体地址：

广东省广州市白云区机场路12号

Institution
hospital：

The First Affiliated Hospital of Guangzhou University of traditional Chinese Medicine

Address：

12 Airport Road, Baiyun District, Guangzhou, Guangdong

经费或物资来源：

国家中医临床基地建设项目；高水平医院建设经费

Source(s) of funding：

National TCM clinical base construction project; high level hospital construction funds

研究疾病：

无

研究疾病代码：

Target disease：

nothing

Target disease code：

研究类型：

Study type：

观察性研究

Observational study

研究设计：

Study design：

连续入组

Sequential

研究所处阶段：

Study phase：

I期临床试验

Phase I clinical trial

研究目的：

针对广州中医药大学第一附属医院院内制剂心阳片，开展在健康成年人群空腹条件下体内中暴露成分的研究。具体包括识别和鉴定的血浆中心阳片的原型成分和代谢产物，确定心阳片在人体内的主要血浆暴露成分，建立了心阳片人体内外化合物之间的关联；推测主要的暴露物质在体内的代谢转化关系。

Objectives of Study：

In view of Xinyang tablet, the hospital preparation of the First Affiliated Hospital of Guangzhou University of traditional Chinese medicine, a study was carried out on the exposure components in the body of healthy adults under the condition of fasting. Specifically, it includes the identification and identification of the prototype components and metabolites of the plasma Central Yang tablet, the determination of the main plasma exposure components of the heart Yang tablet in the human body, the establishment of the relationship between the internal and external compounds of the heart Yang tablet in the human body, and the prediction of the metabolic transformation relationship of the main exposure substances in the body.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

（1）志愿者充分了解试验目的、性质、方法以及可能发生的不良反应，自愿作为志愿者，并在所有研究程序开始前签署知情同意书； （2）年龄为18周岁以上（含临界值）的健康男性或女性志愿者； （3）男性体重≥50.0kg，女性体重≥45.0kg；体重指数（BMI）在19.0~26.0kg/m2范围内（包括临界值）； （4）志愿者三年内无心血管、肝脏、肾脏、胆道、呼吸、血液和淋巴、内分泌、免疫、精神、神经肌肉、胃肠道系统等慢性疾病史或严重疾病史，并且总体健康状况良好； （5）生命体征检查、体格检查、临床实验室检查（血常规、尿常规、血生化）、12-导联心电图，结果显示正常或异常无临床意义者； （6）志愿者（包括男性志愿者）在试验期间及试验结束后6个月内无生育计划并自愿采取有效避孕措施且无捐精、捐卵计划； （7）能够和研究者进行良好的沟通，并且理解和遵守本项研究的各项要求。

Inclusion criteria

(1) Volunteers fully understand the purpose, nature, method and possible adverse reactions of the trial, volunteer as volunteers, and sign the informed consent before all research procedures; (2) Healthy male or female volunteers over the age of 18 (including threshold); (3) The body weight of male >=50.0kg, female >=45.0kg; body mass index (BMI) in the range of 19.0-26.0kg/m2 (including the threshold value); (4) The volunteers had no history of chronic diseases or serious diseases such as cardiovascular, liver, kidney, biliary tract, respiration, blood and lymph, endocrine, immune, mental, neuromuscular, gastrointestinal system, etc. within three years, and were in good general health; (5) Vital signs examination, physical examination, clinical laboratory examination (blood routine, urine routine, blood biochemistry), 12 lead ECG, the results show normal or abnormal without clinical significance; (6) The volunteers (including male volunteers) had no family planning during the experiment and within 6 months after the experiment, and they voluntarily took effective contraceptive measures and had no sperm donation or egg donation plan; (7) Be able to communicate well with researchers and understand and comply with the requirements of this study.

排除标准：

1)过敏体质，如已知对中药、海鲜等物质过敏者（问诊）； 2)在首次服用试验药物前两周内发生急性疾病者（问诊）； 3)试验前6个月内接受过经研究者判断会影响药物吸收、分布、代谢、排泄的手术者，或计划在研究期间进行手术者（问诊）； 4)在首次服用试验药物前2周内使用过任何药物者（包括处方药、非处方药、中草药）（问诊）； 5)试验前28天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；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（问诊）； 6)试验前4周内接受过疫苗接种者（问诊）； 7)试验前3个月内参加过其它临床试验或使用过本试验相关药物者（问诊）； 8)试验前3个月内有献血行为者，6个月内献血或其他原因失血总和达到或超过400mL者（女性生理期正常失血除外）（问诊）； 9)在过去的一年中，有酗酒史，即每周饮酒超过14单位酒精（1单位=360mL啤酒或45mL酒精量为40%的白酒或150mL葡萄酒），或试验期间不能禁酒者，或酒精呼气试验结果大于0.0mg/100mL者（问诊、检查）； 10)试验前3个月内日均吸烟量大于5支，或试验期间不能停止使用任何烟草类产品者（问诊）； 11)试验前3个月内有药物滥用史（包括非医疗目的反复、大量地使用各类麻醉药品和精神药品）或药物滥用筛查（包括：吗啡、冰毒（甲基安非他明）、氯胺酮、摇头丸（二亚甲基双氧安非他明）、大麻（四氢大麻酚酸）等）阳性者（问诊、检查）； 12)输血四项（乙肝表面抗原、丙型肝炎抗体、人类免疫缺陷病毒抗体、梅毒螺旋体抗体）检查任意一项为阳性者（检查）； 13)不能耐受静脉穿刺或有晕针晕血史者（问诊）； 14)乳糖不耐受者（问诊）； 15)对饮食有特殊要求，不能接受统一饮食者（问诊）； 16)根据研究者的判断，具有较低入组可能性或依从性较差（如体弱等）（问诊）；女性志愿者除上述要求外，符合下列条件的也应排除： 17)试验前30天内使用口服避孕药者（问诊）； 18)试验前6个月内使用长效雌激素或孕激素注射剂（含孕激素型宫内节育器）或埋植片者（问诊）； 19)试验前14天内与伴侣发生非保护性性行为者（问诊）； 20)女性血妊娠/尿妊娠检测阳性（检查）； 21)妊娠或哺乳期女性（问诊）。

Exclusion criteria：

1) Allergic constitution, such as those who are known to be allergic to traditional Chinese medicine, seafood and other substances (consultation); 2) Patients with acute disease within two weeks before taking the test drug for the first time (consultation); 3) Those who have received surgery within 6 months before the trial, or who plan to carry out surgery during the study (consultation), which is judged by the researcher to affect drug absorption, distribution, metabolism and excretion; 4) Those who have used any drug (including prescription drug, over-the-counter drug, Chinese herbal medicine) within 2 weeks before taking the test drug for the first time (consultation); 5) 28 days before the test, any drugs that inhibit or induce liver metabolism (such as inducers - barbiturates, carbamazepines, phenytoin, glucocorticoids; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines) were used (for consultation); 6) Those who received vaccination within 4 weeks before the trial (consultation); 7) Those who have participated in other clinical trials or used the drugs related to the trial within 3 months before the trial (consultation); 8) There were blood donors within 3 months before the test, and the total amount of blood loss due to blood donation or other reasons within 6 months reached or exceeded 400ml (except for normal blood loss in female physiological period) (consultation); 9) In the past year, there has been a history of alcoholism, that is, drinking more than 14 units of alcohol per week (1 unit = 360ml of beer or 45ml of white spirit or 150ml of wine with 40% alcohol content), or being unable to prohibit alcohol during the test period, or the alcohol breath test result is greater than 0.0mg/100ml (consultation and examination); 10) Those who smoke more than 5 cigarettes per day in 3 months before the test, or who can't stop using any tobacco products during the test (consultation); 11) In the three months before the trial, there was a history of drug abuse (including repeated and large-scale use of all kinds of narcotic drugs and psychotropic substances for non-medical purposes) or drug abuse screening (including: morphine, methamphetamine, ketamine, ecstasy (dimethyldioxygoamphetamine), marijuana (tetrahydrocannabinolic acid), etc.) positive (consultation and examination); 12) Four blood transfusion tests (hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antibody, Treponema pallidum antibody) were positive; 13) Those who can't tolerate venipuncture or have a history of needle syncope and blood stasis (consultation); 14) Lactose intolerance (consultation); 15) Those who have special requirements for diet and cannot accept unified diet (consultation); 16) According to the judgment of the researcher, there is a low possibility of enrollment or poor compliance (such as physical weakness, etc.); in addition to the above requirements, female volunteers who meet the following conditions should also be excluded: 17) Those who used oral contraceptives within 30 days before the trial (consultation); 18) Those who used long-acting estrogen or progestin injection (including progestin IUD) or implant (consultation) within 6 months before the trial; 19) Unprotected sexual behaviors (consultation) occurred with partners within 14 days before the trial; 20) The blood pregnancy and urine pregnancy were positive; 21) pregnant or lactating women (consultation).

研究实施时间：

Study execute time：

从From 2020-03-01

至To      2020-12-31

征募观察对象时间：

Recruiting time：

从From 2020-03-01

至To      2020-07-31

干预措施：

Interventions：

组别：

心阳片组

样本量：

12

Group：

Case series

Sample size：

干预措施：

心阳片

干预措施代码：

Intervention：

Xinyang Table

Intervention code：

样本总量 Total sample size ： 12

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

广东省

市(区县)：

广州市白云区

Country：

China

Province：

Guangdong

City：

Baiyun District, Guangzhou

单位(医院)：

广州中医药大学第一附属医院

单位级别：

三甲医院

Institution/hospital：

The First Affiliated Hospital of Guangzhou University of traditional Chinese Medicine

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

初步建立药代动力学参数

指标类型：

主要指标

Outcome：

Preliminary establishment of pharmacokinetic 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：

人体内成分的识别和鉴定

指标类型：

主要指标

Outcome：

Identification and identification of human body components

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

生物样品分析条件建立-定性分析

指标类型：

主要指标

Outcome：

Establishment of analytical conditions for biological samples - qualitative analysis

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：

尚未开始

Not yet recruiting

年龄范围：

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

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

N/A

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

N/A

盲法：

N/A

Blinding：

N/A

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）：

不共享

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

Not shared

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：

病例记录表

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

Case Record Form

数据管理委员会：

Data Managemen Committee：

有

Yes

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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