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Human Pharmacokinetic Study of Arginine Acetate Granules
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注册号:

Registration number:

ChiCTR-ONC-11001773 

最近更新日期:

Date of Last Refreshed on:

2016-10-07 

注册时间:

Date of Registration:

2011-12-08 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

醋酸精氨酸颗粒人体药代动力学研究 

Public title:

Human Pharmacokinetic Study of Arginine Acetate Granules 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

醋酸精氨酸颗粒人体药代动力学研究 

Scientific title:

Human Pharmacokinetic Study of Arginine Acetate Granules 

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:

张勇 

研究负责人:

彭曦 

Applicant:

Yong Zhang 

Study leader:

Xi Peng 

申请注册联系人电话:

Applicant telephone:

+86 023 68754149-8062 

研究负责人电话:

Study leader's telephone:

+86 023 68754149-8056 

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:

97yong@gmail.com 

研究负责人电子邮件:

Study leader's E-mail:

pxlrmm@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:

重庆市渝中区长江路10号 

研究负责人通讯地址:

重庆市渝中区长江路10号 

Applicant address:

10 Changjiang Branch Road, Chongqing , China 

Study leader's address:

10 Changjiang Branch Road, Chongqing, 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:

400038 

申请人所在单位:

第三军医大学西南医院烧伤研究所 

Applicant's institution:

Institute of Burn Research, Southwest Hospital, Third Military Medical 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:

KY2004004 

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:

第三军医大学大坪医院医学伦理委员会 

Name of the ethic committee:

Ethic committee of Daping Hospital, the Third Military Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-12-01 

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:

第三军医大学大坪医院 

Primary sponsor:

Daping Hospital, Third Military Medical University 

研究实施负责(组长)单位地址:

重庆市渝中区长江路10号 

Primary sponsor's address:

10 Changjiang Branch Road, Chongqing, 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):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

第三军医大学西南医院

具体地址:

重庆市沙坪坝区高滩岩正街30号

Institution
hospital:

Institute of Burn Research, Southwest Hospital, Third Military Medical University

Address:

30 Gaotanyan street, Shapingba district, Chongqing, China

经费或物资来源:

第三军医大学临床研究基金 

Source(s) of funding:

clinical trial foundation of TMMU 

研究疾病:

正常人 

Target disease:

healthy people 

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:

其它 

Study phase:

N/A 

研究目的:

通过口服给予醋酸精氨酸颗粒,考察醋酸精氨酸颗粒在人体内的代谢规律。 

Objectives of Study:

This study was designed to determine the concentration of arginine acetate in human plasma after oral administration of different doses of arginine acetate granules in healthy Chinese male subjects. 

药物成份或治疗方案详述:

醋酸精氨酸 

Description for medicine or protocol of treatment in detail:

arginine acetate 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

(1)体重指数〔体重(kg)/身高2(m2)〕在19~24范围内;(2)试验前未吸烟、饮酒和药物成瘾史;(3) 无心血管、肝脏、肾脏、消化道、神经系统、精神异常及代谢异常等病史。 

Inclusion criteria

1. Body mass index(BMI) of 19 to 24 kg/m2 (inclusive); 2. No smoking, drinking or drug addiction before or during the study; 3. No history of cardiovascular, renal, gastrointestinal, hepatic, nervous, psychological disease or metabolic disorders. 

排除标准:

(1)2周内使用过其它药物的受试者;1周内服用任何含有精氨酸药品、食品、保健营养品等;(2)对精氨酸过敏者;(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 arginine drug, food, health-care product, medicated diet within one week; 2. Subjects allergic to arginine; 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:

From2005-01-05To 2005-02-17 

征募观察对象时间:

Recruiting time:

From2005-01-05To 2005-02-05 

干预措施:

Interventions:

组别:

3

样本量:

30

Group:

Three groups

Sample size:

干预措施:

给予醋酸精氨酸颗粒

干预措施代码:

Intervention:

administration arginine acetategranules

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

重庆 

Country:

China 

Province:

Chongqing 

City:

Chongqing 

单位(医院):

第三军医大学大坪医院 

单位级别:

三甲 

Institution
hospital:

Daping Hospital, Third Military Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

血浆精氨酸浓度

指标类型:

主要指标 

Outcome:

concentrate of arginine acetate in plasma

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:

血浆

组织:

Sample Name:

plasma

Tissue:

none

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 40 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

中央随机化系统

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

Central randomization

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):

第三军医大学大坪医院

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

Daping Hospital, Third Military Medical University

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:

第三军医大学统计学教研室

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

Department of statistics, Third Military Medical University

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2011-12-08
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