今天是:2019-09-17 星期二

一项单中心、随机、开放、两序列、两周期、自身交叉设计评价中国健康受试者口服多潘立酮干混悬剂的人体生物等效性试验
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注册号:

Registration number:

ChiCTR1900023947 

最近更新日期:

Date of Last Refreshed on:

2019-06-19 

注册时间:

Date of Registration:

2019-06-19 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

一项单中心、随机、开放、两序列、两周期、自身交叉设计评价中国健康受试者口服多潘立酮干混悬剂的人体生物等效性试验  

Public title:

Bioequivalence evaluation of two doperidone suspension in healthy Chinese volunteers: A single-center, randomized, open-label, two-sequence, two-period crossover controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

一项单中心、随机、开放、两序列、两周期、自身交叉设计评价中国健康受试者口服多潘立酮干混悬剂的人体生物等效性试验  

Scientific title:

Bioequivalence evaluation of two doperidone suspension in healthy Chinese volunteers: A single-center, randomized, open-label, two-sequence, two-period crossover controlled 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:

黄倩 

研究负责人:

吴丽花 

Applicant:

Huang Qian 

Study leader:

Wu Lihua 

申请注册联系人电话:

Applicant telephone:

+86 13567177952 

研究负责人电话:

Study leader's telephone:

+86 13819195192 

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:

yingxiting@163.com 

研究负责人电子邮件:

Study leader's E-mail:

lihuawu73@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:

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:

2019伦审第(70)号 

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:

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:

2019-04-11 

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):

Country:

China

Province:

Zhejiang

City:

单位(医院):

浙江大学医学院附属第一医院

具体地址:

浙江省杭州市上城区庆春路79号

Institution
hospital:

The First Affiliated Hospital, Zhejiang University

Address:

79 Qingchun, Hangzhou, Zhejiang, China

经费或物资来源:

由项目申办方浙江亚太药业股份有限公司提供全部资金  

Source(s) of funding:

All funds provided by the project sponsor Zhejiang Yatai pharmaceutical Co., Ltd  

研究疾病:

消化系统 

Target disease:

Digestive system 

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:

其它 

Study phase:

N/A 

研究目的:

在空腹和餐后两种状态下的中国健康受试者中,以协和发酵麒麟株式会社生产的多潘立酮干混悬剂(规格 10mg)为参比制剂,研究单剂量口服浙江亚太药业股份有限公司生产的多潘立酮干混悬剂(规格 10mg)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口服受试制剂和参比制剂的安全性。  

Objectives of Study:

Assessment of bioequivalence of the test(from Zhejiang Yatai pharmaceutical Co., Ltd) and the reference (from Kyowa Hakko Kirin). Formulations of doperidone suspension(10mg)in Chinese healthy subjects by oral administration under both fasting and fed conditions. Secondary Objective: Evaluation of the safety of the test and the reference 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 19~26 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)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);(5) 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 years, 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 19-26kg/m2; 3. subjects in healthy condition, without significant clinical symptoms or abnormal laborary test results of clinical significance; 4. subjects have a fair understanding of the purpose, property, progress and adverse event that may happen, and volunteer to sign the ICF; 5. 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)既往有临床意义的药物过敏史(尤其已知或怀疑对多潘立酮或其辅料成分有过敏史者)或特应性变态反应性疾病史(哮喘、荨麻疹、湿疹性皮炎)或严重的过敏体质者;(3)既往有临床意义的心电图临床病史(如男性 QTc>450ms 和女性QTc>470ms;临床相关的心动过缓;严重的心律失常或症状性心脏衰竭)或长 QT 综合征家族史(祖父母、父母和兄弟姐妹);(4)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、神经精神系统、血液系统、免疫系统疾病及代谢异常等病史者;(5)现伴有胃肠功能障碍、胆道疾病、泌尿道疾病患者,或既往有对药物吸收有影响的消化道疾病史;(6)试验前 2 周内实验室检验(血常规、尿常规、血生化、凝血功能等)和 12 导联心电图、胸部 X 线检查发现异常有临床意义者;(7)血液学筛查 HIV 抗体或 HBV 表面抗原或 HCV 抗体或 TP 抗体阳性者;(8)哺乳期、妊娠期、计划近期怀孕或不能按照避孕要求避孕的女性;(9)妊娠试验阳性者;(10)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;(11)精神或法律上的残疾者;(12)筛选前6个月内有处方药物滥用史和/或非法药物滥用史者;(13)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=360mL 酒精含量为5%的啤酒,或45 mL 酒精含量为40%的烈酒,或150mL酒精含量为12%的葡萄酒)者;(14)药物滥用测试或酒精测试或烟碱检测阳性者;(15)筛选前3个月内有住院史或手术史者(阑尾炎除外);(16)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;(17)筛选前3个月内参加过其它药物临床试验者;(18)筛选前1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);(19)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);(20)对饮食有特殊要求,不能接受统一饮食者(21)乳糖不耐受性者(曾发生过喝牛奶腹泻者);(22)研究者判断因其他原因不适合参加该研究的试验者。  

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. clinical history of ECG with previous clinical significance (e.g., male QTc>450ms and female QTc>470ms); Clinically relevant bradycardia; A family history of severe arrhythmia or symptomatic heart failure or long QT syndrome (grandparents, parents and siblings); 4. 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; 5. patients with gastrointestinal dysfunction, biliary diseases, and urinary tract diseases, or have a history of digestive tract diseases affecting drug absorption; 6. labotory test: hemotology, urinalysis, blood biochemistry, chest X-ray, 12-lead ECG. Any of the above items is abnormal and determined clinical significant by researchers; 7. One of HbsAg, HCV antibody, HIV antibody, syphilis turn out to be positive; 8. Female subjects under pregenancy, lactation, or cannot take conspective measures; 9. positive pregnancy test; 10. male subjects fail to take effective contraceptive measures or their spouses plan to give birth within six months; 11. mentally or legally disabled; 12. screening those with a history of prescription drug abuse and/or illegal drug abuse within the first 6 months; 13. 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); 14. drug abuse test or alcohol test or nicotine test positive; 15. patients with a history of hospitalization or surgery (except for appendicitis) within the first 3 months; 16. those with a history of blood donation or acute blood loss in the first 2 months (400 mL) or who intend to donate blood within 1 month after the end of the test were screened; 17. select those who have participated in other drug clinical trials within the first 3 months; 18. subject 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; 19. subject refuses to stop any food or revee with methylxanthine, such as caffeine (coffee, tea, coke, choclate)from 2 days before to the end of the study; 20. those with special dietary requirements who cannot accept the unified diet; 21. those with lactose intolerance (those who have had milk diarrhea); 22. subject insuitable to the study according to researchers.  

研究实施时间:

Study execute time:

From2019-06-17To 2019-06-30 

干预措施:

Interventions:

组别:

Group 2

样本量:

30

Group:

Group 2

Sample size:

干预措施:

浙江亚太药业股份有限公司生产的多潘立酮干混悬剂

干预措施代码:

Intervention:

Zhejiang Yatai pharmaceutical Co., Ltd made doperidone suspension

Intervention code:

组别:

Group 1

样本量:

30

Group:

Group 1

Sample size:

干预措施:

协和发酵麒麟株式会社生产的多潘立酮干混悬剂

干预措施代码:

Intervention:

Kyowa Hakko Kirin made doperidone suspension

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

The 1st affiliated hospital, school of Medicine, Zhejiang University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

血药浓度时间曲线下面积

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:

指标中文名:

血药浓度峰值

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:

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

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 SAS 统计学软件(9.2 或更高版本)生成随机表。每部分研究均随机分成TR和RT两组

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

The order in which each subject received the test preparation (T) and the reference preparation (R) was determined according to a random table. Statisticians use SAS statistical software (9.2 or higher) to generate a random table. Each part of the study was randomly divided into TR and RT groups.

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):

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:

CRF EDC

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

CRF EDC

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-06-19
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