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Human Pharmacokinetic Study of Sanqi Extract
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注册号:

Registration number:

ChiCTR-ONRC-09000603 

最近更新日期:

Date of Last Refreshed on:

2015-05-17 

注册时间:

Date of Registration:

2009-11-20 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

三七水提物人体药代动力学研究 

Public title:

Human Pharmacokinetic Study of Sanqi Extract 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

三七水提物人体药代动力学研究(Human Pharmacokinetic Study of Sanqi Extract) 

Scientific title:

Human Pharmacokinetic Study of Sanqi (Panax notoginseng) Extract 

研究课题代号(代码):

Study subject ID:

2005CB523403 

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:

杨军令 

研究负责人:

李川 

Applicant:

Junling Yang 

Study leader:

Chuan Li 

申请注册联系人电话:

Applicant telephone:

+86 21 50802121-2102 

研究负责人电话:

Study leader's telephone:

+86 21 50803106 

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:

yangjl1983@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

chli@mail.shcnc.ac.cn 

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:

上海浦东松涛路646号402室 

研究负责人通讯地址:

上海浦东张江高科技园区祖冲之路555号 

Applicant address:

Room 402, 646 Songtao Road, Zhangjiang Hi-Tech Park, Pudong, Shanghai, China 

Study leader's address:

555 Zuchongzhi Road, Zhangjiang Hi-Tech Park. Pudong, Shanghai. China 

申请注册联系人邮政编码:

Applicant postcode:

201203 

研究负责人邮政编码:

Study leader's postcode:

201203 

申请人所在单位:

中科院上海药物研究所 

Applicant's institution:

Li Chuan(Shanghai Institute of Materia Medica, Chinese Academy of Sciences) 

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:

2009YL042 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

天津中医药大学第二附属医院伦理审查委员会 

Name of the ethic committee:

Ethic Committee of 2nd Affiliated Hospital of Tianjin University of TCM 

伦理委员会批准日期:

Date of approved by ethic committee:

2009-12-01 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

中科院上海药物研究所、天津中医药大学 

Primary sponsor:

Shanghai Institute of Materia Medica, Chinese Academy of Science; Tianjin University of TCM 

研究实施负责(组长)单位地址:

上海浦东张江高科园区祖冲之路555号 

Primary sponsor's address:

555 Zuchongzhi Road, Zhangjiang Hi-Tech Park. Pudong, Shanghai. China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

国家科技部 

Source(s) of funding:

Chinese Ministry of Science and Technology 

研究疾病:

正常人 

Target disease:

Healthy Volunteers 

研究疾病代码:

N/A 

Target disease code:

N/A 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

I期临床试验 

Study phase:

研究目的:

(1)系统考察人体受试者口服三七后皂苷类成分的体内暴露物质谱;(2)考察受试者的服药剂量与活性成分暴露水平的相关性;(3)考察三七皂苷类成分随尿排泄特征,尿排泄与给药剂量的关系、尿排泄与系统暴露的关系;(4)考察由肠道微菌群代谢产物C-K在人体内的暴露特征及其与给药剂量的相关性;(5)比较不同三七皂苷类成分的系统暴露的个体差异程度;(6)在累积给药情况下,皂苷类成分体内系统暴露的变异情况。上述几方面的研究考察,将有利于了解人体与大鼠在三七口服给药后系统暴露的种属差异,为三七中药品种的临床试验、技术改造和新药研发提供科学依据。 

Objectives of Study:

1. To systemically investigate exposed substance in human after oral ingestion of Sanqi extract; 2. To study the dose proportionality of exposed active components; 3. To explore the characterization the urinary excretion properties of ginsenosides, the relationship of urinary excretion and dose, and the relationship of urinary excretion and systemic exposure; 4. To know systemic exposure and dose proportionality of C-K, the deglycosylated products by intestinal bacteria; 5. To compare the individual differences of different ginsenosides; 6. To understand the differences of systemic exposure of ginsenosides after multiple oral dose and single oral dose. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

(1)健康受试者,男女各半,年龄18-35岁,体重指数不超过理想值的15%。 (2)受试者知情,并签署知情同意书。 

Inclusion criteria

1. Healthy human subjects between 18 to 35 years old with body mass index not exceeding the ideal value more than 15%; 2. Subjects who understand the purpose, character, procedures of the pharmacokinetic study, as well as the characteristics of Sanqi extract. Subject signed Informed Consent Form prior to this study. 

排除标准:

(1)2周内使用过其它药物的受试者;1周内服用任何含有人参、西洋参、三七的药品、食品、保健营养品、药膳等; (2)对三七、人参、西洋参成分或产品过敏及过敏体质受试者; (3)一个月内参加过其它药物试验的受试者; (4)经期、妊娠期、哺乳期妇女、及育龄期妇女服用避孕药者; (5)研究者认为不适合进入试验的任何其它因素。 

Exclusion criteria:

1. Subjects who took any over-the-counter or prescription drugs within two weeks or any Asian ginseng, American ginseng, or Sanqi-related drug, food, health-care product, medicated diet within one week; 2. Subjects allergic to Asian ginseng, American ginseng, or Sanqi gradient or product; 3. Subjects who participated any investigational drug study within 1 months prior to this study; 4. Menstrual, pregnant or lactating women and women at childbearing age take oral contraceptive; 5. In the opinion of the investigator, subjects who are not suitable to participate in the study for whatever reasons must be excluded. 

研究实施时间:

Study execute time:

From2009-12-11To 2011-11-30 

征募观察对象时间:

Recruiting time:

From2009-12-02To 2011-06-30 

干预措施:

Interventions:

组别:

组A

样本量:

8

Group:

Group A

Sample size:

干预措施:

三七水提物90 ml,口服,给药后0、0.5、1.5、3、4.5、8、12、15、24、30、38、48、56h肘前静脉埋管取血~1 mL,0、0-3、3-6、6-10、10-14、14-24、24-32、32-40、40-48、48-72 h时间段收集完整尿样。本组男性受试者间隔3天后开始多次给药试验,连续21天每天口服90 ml三七水提物。在单次给药的三天内及连续给药的第7、14、21天检测血药、尿药浓度

干预措施代码:

Intervention:

Sanqi extract, 90 ml, orally taken. Three days after the single dose,male subjects in this group orally taken 90 ml sanqi extract once daily for 21 days. Plasma and urinary drug concentration were monitored within three days after single oral dose and in the 7th, 14th, 21th days during the consecutive oral dose

Intervention code:

组别:

组B

样本量:

8

Group:

Group B

Sample size:

干预措施:

三七水提物180 ml,口服一次。药后0、0.5、1.5、3、4.5、8、12、15、24、30、38、48、56h肘前静脉埋管取血~1 mL, 0、0-3、3-6、6-10、10-14、14-24、24-32、32-40、40-48、48-72 h时间段收集完整尿样。

干预措施代码:

Intervention:

Sanqi extract, 180 ml, orally taken.Plasma and urinary drug concentration were monitored within three days after oral dose

Intervention code:

组别:

组C

样本量:

8

Group:

Group C

Sample size:

干预措施:

三七水提物270 ml,口服一次。药后0、0.5、1.5、3、4.5、8、12、15、24、30、38、48、56h肘前静脉埋管取血~1 mL, 0、0-3、3-6、6-10、10-14、14-24、24-32、32-40、40-48、48-72 h时间段收集完整尿样。

干预措施代码:

Intervention:

Sanqi extract, 270 ml, orally taken. plasma at 0, 0.5, 1.5, 3, 4.5, 8, 12, 15, 24, 30, 38, 48, 56 h and urine at 0-3, 3-6, 6-10, 10-14, 14-24, 24-32, 32-40,40-48, 48-72 h postdose were collected

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津中医药大学第二附属医院 

单位级别:

三级甲等 

Institution
hospital:

2nd Affiliated Hospital of Tianjin University of TCM  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

血药浓度

指标类型:

主要指标 

Outcome:

Drug concentration in plasma

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿药浓度

指标类型:

主要指标 

Outcome:

Drug concentration in urine

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:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 35 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):

N/A

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

N/A

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

中科院上海药物研究所,天津中医药大学第二附属医院

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

Shanghai Institute of Materia Medica,2nd Affiliated Hospital of Tianjin University of TCM

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:

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

Shanghai Institute of Materia Medica,2nd Affiliated Hospital of Tianjin University of TCM

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2009-11-20
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