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食物对人参皂苷C-K药代动力学的影响
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注册号:

Registration number:

ChiCTR-IPR-15005787 

最近更新日期:

Date of Last Refreshed on:

2015-01-06 

注册时间:

Date of Registration:

2015-01-06 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

食物对人参皂苷C-K药代动力学的影响 

Public title:

The effect of food on the pharmacokinetics of Ginsenoside C-K 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

食物对健康志愿者口服人参皂苷C-K片药代动力学影响的研究 

Scientific title:

To study the effect of food on pharmacokinetics of Ginsenoside C-K tablet in healthy volunteers 

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:

王亚芹 

研究负责人:

欧阳冬生 

Applicant:

Yaqin Wang 

Study leader:

DongSheng Ouyang 

申请注册联系人电话:

Applicant telephone:

+86 15243674841 

研究负责人电话:

Study leader's telephone:

+86 13307313736 

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:

kfwangyaqin1990@163.com 

研究负责人电子邮件:

Study leader's E-mail:

ouyangyj@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:

湖南省长沙市开福区湘雅路中南大学临床药理研究所 

研究负责人通讯地址:

湖南省长沙市开福区湘雅路中南大学临床药理研究所 

Applicant address:

Institute of Clinical Pharmacology, Central South University, No. 110, Xiangya Road, Changsha, Hunan, China 

Study leader's address:

Institute of Clinical Pharmacology, Central South University, No. 110, Xiangya Road, Changsha, Hunan, China 

申请注册联系人邮政编码:

Applicant postcode:

410078 

研究负责人邮政编码:

Study leader's postcode:

410078 

申请人所在单位:

中南大学 

Applicant's institution:

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:

14119 

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:

中南大学湘雅三医院伦理委员会 

Name of the ethic committee:

the Ethics Committee of the Third Xiangya Hospital of Central South University 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-11-21 

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:

中南大学临床药理研究所 

Primary sponsor:

Institute of Clinical Pharmacology, Central South University 

研究实施负责(组长)单位地址:

湖南省长沙市开福区湘雅路中南大学临床药理研究所 

Primary sponsor's address:

Institute of Clinical Pharmacology, Central South University, No. 110, Xiangya Road, Changsha, Hunan, 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):

中南大学临床药理研究所

具体地址:

湖南省长沙市开福区湘雅路中南大学临床药理研究所

Institution
hospital:

Institute of Clinical Pharmacology, Central South University

Address:

No. 110, Xiangya Road, Changsha, Hunan, China

经费或物资来源:

企业提供 

Source(s) of funding:

provided by enterprises 

研究疾病:

类风湿性关节炎 

Target disease:

rheumatoid arthritis 

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:

研究目的:

在健康志愿者中研究空腹与餐后单次口服给予人参皂苷C-K片后受试者的药动学特征,为后期临床研究制定给药方案提供依据。 

Objectives of Study:

Study the effect of food on pharmacokinetics of Ginsenoside C-K tablet in healthy volunteers after a single dose, and provide a theoretical basis for the late clinical trials to adjust the therapeutic regimen. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1)性别:男性或女性;2)年龄:18~45周岁之间,同批年龄相差不超过10岁;3)体重:女性体重≥45 kg,男性体重≥50 kg,受试者体重指数(BMI)在19~24 kg/m2之间(BMI=体重(kg)/身高2(m2)),包括边界值,同批体重相差不宜悬殊;4)依据体格检查、病史、生命体征、心电图和临床实验室检查的结果,研究者认为受试者的健康状况良好,无心、肝、肾、消化道、神经系统、精神异常及代谢异常等病史;经全面体格检查及生命体征检查显示血压、体温、心率、呼吸状况以及实验室检查包括心电图、胸片、血常规、尿常规、肝肾功能、血糖、血脂、血清电解质、心肌酶、凝血功能、输血四项、血妊娠(女性)各项实验室检查均无异常或异常无临床意义(以临床医师判断为准);5)受试者必须在试验前对本研究知情同意,并自愿签署了书面的知情同意书;6)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

1. Sex: male or female; 2. Age: 18~45 years old, the age difference in the same group is not more than 10 years; 3 weight: female weight greater than or equal to 45 kg, male weight greater than or equal to 50 kg, the body mass index (BMI) in 19~24 kg/m2 (BMI= body weight (kg)/height 2 (M2)), including the boundary value; 4. On the basis of a physical examination, medical history, vital signs, electrocardiogram and clinical laboratory test results, the researchers believe that the subjects in good health, heart, liver, kidney, gastrointestinal, neurological, psychiatric disorders and metabolic disorders and other medical history; the complete physical examination and vital signs, body temperature, heart rate and blood pressure check display, respiratory conditions and laboratory examination including ECG, chest X-ray, blood routine, urine routine, liver and kidney function, blood glucose, blood lipid, serum electrolytes, myocardial enzyme, blood coagulation function, blood transfusion, pregnancy (four women) the laboratory examination showed no abnormality or no clinical significance of abnormal (to the clinician's judgment shall prevail); 5. subjects must be informed consent before the trial, and voluntarily signed the written informed consent; 6. subjects can communicate with the researchers and be able to finish the study in accordance with the protocol. 

排除标准:

1)过敏体质或已知对本品或其任何辅料过敏者; 2) 有循环系统、内分泌系统、神经系统、消化系统、呼吸系统、血液学、免疫学、精神病学及代谢异常等任何临床严重疾病史者或能干扰试验结果的任何其他疾病或生理情况; 3) 正在接受胃肠道问题、痉挛、消化道溃疡、尿路梗塞、机械性肠梗阻、输尿管痉挛、胆道疾病、抑郁障碍或肝脏疾病治疗者; 4) 患有能够影响药物吸收或代谢的胃肠道及肝、肾疾病者; 5) 试验前4周内接受过外科手术者; 6) 已知的能够影响静脉取血的严重出血因素; 7) 有恶性肿瘤病史者; 8) 试验前30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、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; 9) 心电图异常(具有临床意义)或生命体征异常者(收缩压<90 mmHg或>140 mmHg,舒张压<50 mmHg或>90 mmHg;心率<50 bpm或>100 bpm); 10) HIV、乙型肝炎表面抗原、丙型肝炎或梅毒螺旋体抗体检测阳性者; 11) 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); 12) 嗜烟者或试验前3个月每日吸烟量多于5支者; 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) 任何食物过敏或对饮食有特殊要求,不能遵守统一饮食者; 15) 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; 16) 试验前14天内服用过任何药物者; 17) 试验前3个月内服用了任何临床试验药物或参加了任何药物临床试验者; 18) 试验前3个月献血或作为受试者被采样者; 19) 受试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。 女性受试者除上述要求外,符合下列条件的也应排除 1) 试验前30天已服用或试验期间计划服用口服避孕药者; 2) 试验前6个月内已使用或试验期间计划使用长效雌激素或孕激素注射剂或埋植片者; 3) 育龄女性试验前14天内与伴侣发生非保护性性交者; 4) 筛选期或试验期间可能处于月经周期者; 5) 妊娠期及哺乳期女性。 

Exclusion criteria:

1. allergic or known to this product or any of its accessories allergy; 2. circulating system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and abnormal metabolism of any clinical history of serious illness or to interfere with the test results of any other disease or physical condition; 3. undergoing gastrointestinal problems, spasm, gastrointestinal ulcer, urinary infarction, intestinal obstruction, ureteral spasm, biliary tract disease, depression or liver disease; 4. with can affect drug absorption or metabolism of gastrointestinal and liver, kidney disease; 5. test within 4 weeks before treated with surgical operation; 6. known to affect the venous blood of serious hemorrhage factors; 7. with malignant tumor of history; 8. test 30 days before the use of any inhibition or induction of hepatic drug on drug metabolism (such as: inducing agent, barbiturates, phenytoin, C Masi Bing, glucocorticoid, Omeprazole; inhibitor SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazole, sedative hypnotics, Vera Pammy, fluoroquinolones, antihistamine) who; Abnormal ECG; 9. with clinical significance of vital signs) or abnormal (systolic blood pressure lower than 90 mmHg or higher than 140 mmHg, lower than 50 mmHg or higher than 90 mmHg diastolic blood pressure; heart rate less than 50 BPM or more than 100 BPM); 10. HIV, hepatitis B surface antigen, hepatitis or syphilis antibody positive; 11. alcoholic or 6 months before the test current drinkers, drinking more than 14 units of alcohol per week (1 units of =360 mL beer or 45 mL alcohol content of 40% spirits or 150 mL Wine); 12. smoker or test before 3 months of daily smoking more than 5 cigarettes; 13. drug abusers or test 3 months before the use of soft drugs (such as: marijuana) or test 1 years ago taking hard drugs (such as: cocaine, PCP etc.) who; 14. any food allergies or food to have special requirements, can not comply with the uniform diet; 15. every day drinking too much tea, Coffee and / or caffeinated beverages (more than 8 cups, 1 cup of =250 ml) who; 16. test 14 days before taking any drugs; 17. test in the 3 months before taking any drug clinical trials or in any drug clinical trials; 18. test 3 months before the blood donation or be sampled as the subjects'; 19. subjects may be because of other reasons not to complete this study or research that should not be included in the party. Female subjects in addition to the above requirements, in accordance with the following conditions should also be excluded: 1) plan has been taken for 30 days before the test or tests during the taking oral contraceptives; 2) program has been using test within 6 months before or during the trial use of long-acting estrogen or progesterone injection or implantation of the piece; 3) women of childbearing age before the test within 14 days with a partner who has unprotected sexual intercourse; 4) during the screening period or in the menstrual cycle test; 5) during pregnancy and lactating women. 

研究实施时间:

Study execute time:

From2015-01-15To  

征募观察对象时间:

Recruiting time:

From2015-01-15To  

干预措施:

Interventions:

组别:

Two groups

样本量:

24

Group:

Two groups

Sample size:

干预措施:

空腹或进食后给予人参皂苷C-K片

干预措施代码:

Intervention:

Ginsenoside compound K is administrated after taking food versus fasting

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:

三级甲等医院 

Institution
hospital:

the Third Xiangya Hospital, Central South University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

血浆,尿样,粪便中人参皂苷C-K及其代谢产物药物浓度

指标类型:

主要指标 

Outcome:

Plasma, urine, concentration of ginsenoside C-K and its metabolites in feces of drugs

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:

标本中文名:

尿液

组织:

Sample Name:

Urine

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

粪便

组织:

Sample Name:

Faeces

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 years
最大 Max age 45 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):

由统计学老师用SAS软件产生随机序列

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

with SAS software to generate random sequence by statistics teacher

盲法:

Blinding:

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):

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

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:

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2015-01-06
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