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单中心、随机、开放、两周期、交叉设计评价中国健康受试者单次、空腹和餐后给予盐酸帕罗西汀片 的人体生物等效性试验
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注册号:

Registration number:

ChiCTR1800018699 

最近更新日期:

Date of Last Refreshed on:

2018-10-04 

注册时间:

Date of Registration:

2018-10-04 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

单中心、随机、开放、两周期、交叉设计评价中国健康受试者单次、空腹和餐后给予盐酸帕罗西汀片 的人体生物等效性试验 

Public title:

Bioequivalence evaluation of two paroxetine tablets before and after meals in healthy Chinese volunteers: A Single-dose, randomized, open-label, two-period crossover trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

单中心、随机、开放、两周期、交叉设计评价中国健康受试者单次、空腹和餐后给予盐酸帕罗西汀片 的人体生物等效性试验 

Scientific title:

Bioequivalence evaluation of two paroxetine tablets before and after meals in healthy Chinese volunteers: A Single-dose, randomized, open-label, two-period crossover trial 

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:

徐畅 

研究负责人:

申屠建中 

Applicant:

Xu Chang 

Study leader:

Shentu Jianzhong 

申请注册联系人电话:

Applicant telephone:

+86 15167131586 

研究负责人电话:

Study leader's telephone:

+86 0571-87236560 

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:

holly_xc@163.com 

研究负责人电子邮件:

Study leader's E-mail:

stjz@zju.edu.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:

浙江省杭州市上城区庆春路79号 

研究负责人通讯地址:

浙江省杭州市上城区庆春路79号 

Applicant address:

79 Qingchun, Hangzhou, Zhejiang, China 

Study leader's address:

79 Qingchun, Hangzhou, Zhejiang, 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:

浙江大学医学院附属第一医院 

Applicant's institution:

The First Affiliated Hospital, Zhejiang 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:

2018-234 

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:

浙江大学医学院附属第一医院医学伦理委员会 

Name of the ethic committee:

Ethics Commitee of the first Affliated Hospital, College of Medicine, Zhejiang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-02-08 

伦理委员会联系人:

周惠丽 

Contact Name of the ethic committee:

Zhou Huili 

伦理委员会联系地址:

浙江省杭州市上城区庆春路79号 

Contact Address of the ethic committee:

79 Qingchun, Hangzhou, Zhejiang, China 

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:

浙江大学医学院附属第一医院 

Primary sponsor:

The First Affiliated Hospital, Zhejiang University 

研究实施负责(组长)单位地址:

浙江省杭州市上城区庆春路79号 

Primary sponsor's address:

79 Qingchun, Hangzhou, Zhejiang, 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):

浙江

市(区县):

金华

Country:

China

Province:

Zhejiang

City:

Jinhua

单位(医院):

浙江尖峰药业有限公司

具体地址:

浙江省金华市婺城区白汤下线高畈段58号

Institution
hospital:

Jianfeng Pharmaceuticals

Address:

88 East Wujiang Road, Jinhua, Zhejiang

经费或物资来源:

由项目申办浙江尖峰药业有限公司提供全部资金 

Source(s) of funding:

All funds provided by the project sponsor Zhejiang Jianfeng Pharmaceutical Co., Ltd. 

研究疾病:

抑郁症 

Target disease:

Depression 

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:

主要研究目的:在空腹和餐后两种状态下的中国健康受试者中,以原研Apotex Technologies 生产的盐酸帕罗西汀片(规格 20 mg,商品名: PAXIL)为参比制剂,研究单剂量口服浙江尖峰药业有限公司生产的盐酸帕罗西汀片(规格 20mg)后该药的体内经时过程,计算其药代动力学参数,比较两种制剂的人体相对生物利用度以评价两者的生物等效性。 次要研究目的:观察和评价空腹和餐后单剂量口服受试制剂和参比制剂的安全性。 

Objectives of Study:

Main objectives: Assessment of bioequivalence of the test(from Jianfeng) and the reference(from Apotex Technologies) formulations of Paroxetine Tablets(20mg) in Chinese healthy subjects by oraly administration under both fasting and fed conditions. Secondary Objective: Evaluation of the safety of the test and the reference formulations in healthy Chinese subjects.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机交叉对照 

Study design:

Cross-over 

纳入标准:

(1) 年龄 18-45 周岁(含 18 和 45 周岁),男女均可; (2) 男性受试者体重 50kg 以上(含 50kg),女性受试者体重 45kg 以上(含 45kg);体重指数[BMI=体重(kg)/身高(m)2]在 19~28 kg/m2范围内; (3) 根据既往病史、全面的体格检查和规定实验室检验检查,经研究者判定为健康受试者; (4) 受试者若为有生育能力的女性,需同意签署知情同意书起至末次给药后至少 6 个月采取适当的避孕措施;若受试者为男性,其配偶或伴侣也需在上述时间内采取适当的避孕措施。 (5) 充分了解试验目的、试验性质、研究程序以及可能发生的不良反应,自愿参加本试验并签署知情同意书(获得知情同意书过程符 合 GCP 规定); (6) 能与研究者良好沟通,理解和遵从本研究的各项要求,并愿意按照规定入住 I 期临床研究病房。 

Inclusion criteria

1. Aged 18-45, healthy male and female subjects; 2. Male subjects with weight ≥50kg, female subjects with weight ≥45kg; body mass index [BMI=weight (kg)/height (m)2] within the range of 19-28kg/m2; 3. subjects in healthy condition, without significant clinical symptoms or abnormal laborary test results of clinical significance; 4. Fertilizable female subejects agree to taken appropriate contraception methods since signing ICF to 6 months after study; male subjects agree to take appropriate contraception methods with their partner in the same period; 5. subjects have a fair understanding of the purpose, property, progress and adverse event that may happen, and volunteer to sign the ICF; 6. Subject are able to proceed a smooth Communication with researchers, and a good compliance to the requirements of the study. subject are willing to say at Phase I study wards according to rules. 

排除标准:

(1) 不能耐受静脉穿刺采血者; (2) 已知对研究药物或其活性成分辅料过敏的受试者,以及已知有变态反应性疾病病史或为过敏体质者; (3) 有任何临床严重疾病史,包括但不限于消化系统、心血管系统、呼吸系统、泌尿系统、肌肉骨骼系统、内分泌系统、神经系统、 血液系统、免疫系统疾病及代谢异常等病史者; (4) 试验前 2 周内实验室检验(血常规、尿常规、血生化、血液学筛查等)和胸片、心电图检查中有任何项异常并经研究医生判断有临床意义者; (5) 妊娠期、哺乳期、妇女和不能依照要求进行避孕的育龄妇女; (6) 男性受试者未采取有效的避孕措施或其配偶计划六个月内生育者; (7) 精神或法律上的残疾者; (8) 有处方药物滥用史和/或非法药物滥用史者; (9) 试验前 6 个月内平均每日吸烟量多于 5 支,或试验期间不能停止使用任何烟草类产品者;试验前 6 个月内或试验期间经常饮酒者,即每周饮酒超过 14 单位酒精( 1 单位=360 mL 酒精含量为 5%的啤酒,或 45 mL 酒精含量为 40 %的烈酒,或 150 mL 酒精含量为12%的葡萄酒)者; (10)药物滥用检测、酒精检测、烟检筛查阳性者; (11)筛选前 2 个月内有献血或急性失血史者( ?400 mL)或试验结束后 1 个月内打算献血者;筛选前 3 个月内参加过其它药物临床试验者; (12)筛选前一个月内接受过疫苗接种,使用任何处方药、中草药类补药,和/或者筛选前 2 周内使用任何非处方药、食物补充剂(包括维生素); (13)在研究开始前 48 小时直至研究结束,受试者拒绝停用任何包含甲基黄嘌呤的饮料或食物,例如咖啡因(咖啡、茶、可乐、巧克力等); (14)在研究开始前 1 周直至研究结束,受试者拒绝停用任何包含葡萄柚的饮料或食物; (15)最近在饮食或运动习惯上有重大变化者; (16)经研究者判断,不适合参加试验者。 

Exclusion criteria:

1. subject cannot tolarate veinpunture; 2. Subject allergic to the study drug or its ingredients; subject has history of allergy or belongs to allergic constitution; 3. Subject has/had any history of serious disease, including but not limited to digestive, cardiovascular, respiratory, urinary, musculoskeletal, endorine, nervous, hemotologic, immune system or metabolic disorder; 4. labotory test: hemotology, urinalysis, blood biochemistry, HbsAg, HCV antibody, HIV antibody, syphilis, chest X-ray, 12-lead ECG. Any of the above items is abnormal and determined clinical significant by researchers. 5. Female subjects under pregenancy, lactation, or cannot take conspective measures; 6. Male subjects cannot take conspective measures or his parter plans to get pregnancy in 6 months; 7. Disability mentally or legally; 8. Subjects has history of abusement of prescription/illegal drugs; 9. subject took over 5 cigarettes every day in the past 12 months, or cannot quit smoking during the study; subject drank frequently in the past 6 months, namely 14 unit alcohol every week( 1 unit =360ml beer with 5% alcohol, 45ml liquor with 40% alcohol, 150 ml wine with 12% alcohol); 10. Urine tests of drug abuse, alchol or smoking turn to be positive; 11. Subjects donated blood or experience an acute blood loss(over 400ml) 2 week prior to screening; subject participated in other clinical trial 3 month before screening; 12. suject had vaccination, any prescription or Chinese herbal medicine 4 weeks prior to first administration; subject took any OTC, food suppliment(including vitamin) 2 weeks prior to first administration; 13. subject refuses to stop any food or reverge with methylxanthine, such as caffeine (coffee, tea, coke, choclate) from 2 days before to the end of the study; 14. subject refused to stop any food or reverage with grapefruit from 7 days before to the end of the study; 15. subject has a big change in his/her diet or exercise; 16. subject insuitable to the study according to researchers.  

研究实施时间:

Study execute time:

From2018-10-15To 2018-10-13 

征募观察对象时间:

Recruiting time:

From2018-10-09To 2018-10-23 

干预措施:

Interventions:

组别:

TR

样本量:

28

Group:

TR

Sample size:

干预措施:

第一周期受试制剂第二周期参比制剂

干预措施代码:

Intervention:

test drug in the 1st period and reference drug in the 2nd period

Intervention code:

组别:

RT

样本量:

28

Group:

RT

Sample size:

干预措施:

第一周期参比制剂第二周期受试制剂

干预措施代码:

Intervention:

reference drug in the 1st period and test drug in the 2nd period

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

杭州 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江大学医学院附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital, ZheJiang Univercity  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

Cmax

指标类型:

主要指标 

Outcome:

Cmax

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

AUC

指标类型:

主要指标 

Outcome:

AUC

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 years
最大 Max age 45 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):

每位受试者接受受试制剂(T)和参比制剂(R)的顺序根据随机表确定。统计人员使用SAS9.4及以上版本统计学软件按1:1比例生成随机表。每部分研究均随机分成TR和RT两组。TR组第一周期给予受试制剂,第二周期给予参比制剂;RT组第一周期给予参比制剂,。空腹试验与餐后试验的分组程序相同。

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

Subjects were randomly assigned to 2 groups according to a randomization table generated by SAS Enterprise Guide(V9.4 or more) (SAS Institute Inc, Cary, North Carolina) as Group A and B. Group A received the test drugs in the first treatment period and the reference in the second, and the administration

盲法:

未说明

Blinding:

Not stated

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

浙江大学医学院附属第一医院

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

The First Affiliated Hospital,ZheJiang Univercity

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:

eCRF

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

eCRF

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2018-10-04
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