今天是:2019-11-17 星期日

开洁静医师:请填写伦理委员会联系人。 单中心、随机、开放、两周期、交叉设计评价中国健康受试者空腹和餐后单次给予盐酸氟桂利嗪胶囊的人体生物等效性试验
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注册号:

Registration number:

ChiCTR1900026713 

最近更新日期:

Date of Last Refreshed on:

2019-10-19 

注册时间:

Date of Registration:

2019-10-19 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

开洁静医师:请填写伦理委员会联系人。 单中心、随机、开放、两周期、交叉设计评价中国健康受试者空腹和餐后单次给予盐酸氟桂利嗪胶囊的人体生物等效性试验 

Public title:

Single-center, randomized, open, two-cycle, crossover design to evaluate the bioequivalence of flunarizine hydrochloride capsules in Chinese healthy subjects on fasting and postprandial basis 

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空腹和餐后单次给予盐酸氟桂利嗪胶囊的人体生物等效性试验 

Scientific title:

Single-center, randomized, open, two-cycle, crossover design to evaluate the bioequivalence of flunarizine hydrochloride capsules in Chinese healthy subjects on fasting and postprandial basis 

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:

开洁静 

研究负责人:

吴国兰 

Applicant:

Kai Jiejing 

Study leader:

Wu Guolan 

申请注册联系人电话:

Applicant telephone:

+86 18758890169 

研究负责人电话:

Study leader's telephone:

+86 13706716920 

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:

kaijiejing@163.com 

研究负责人电子邮件:

Study leader's E-mail:

yilanlan_001@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, Shangcheng District, Hangzhou, Zhejiang, China  

Study leader's address:

79 Qingchun, Shangcheng District, 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伦审第(333)号 

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:

2018-11-15 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

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, Shangcheng District, 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, Shangcheng District, 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):

杭州市

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

正大青春宝药业有限公司

具体地址:

西溪路551号

Institution
hospital:

Chiatai Qingchunbao Pharmaceutical Co., Ltd.

Address:

551 Xixi Road

经费或物资来源:

由项目申办方正大青春宝药业有限公司 提供全部资金 

Source(s) of funding:

All funds provided by the project sponsor Chiatai Qingchunbao pharmaceutical Co., Ltd 

研究疾病:

migraine 

Target disease:

偏头痛 

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:

比较在空腹及餐后状态下,中国健康受试者单剂量口服正大青春宝药业有限公司研制生产的盐酸氟桂利嗪胶囊(受试制剂T)与西安杨森制药有限公司生产的盐酸氟桂利嗪胶囊(商品名:西比灵,参比制剂R)后血浆中氟桂利嗪的浓度,以氟桂利嗪的药动学参数为终点评价指标,评价受试制剂与参比制剂是否为等效制剂,同时评估受 试制剂与参比制剂的安全性。  

Objectives of Study:

Assessment of bioequivalence of the test(from Chiatai Qingchunbao pharmaceutical Co., Ltd) and the reference (from Xian Janssen Pharmaceutical Ltd.). Formulations of Flunarizine Hydrochloride Capsules in Chinese healthy subjects by oral administration under both fasting and fed conditions. 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:

正大青春宝药业有限公司盐酸氟桂利嗪胶囊(受试制剂T); 西安杨森制药有限公司生产的盐酸氟桂利嗪胶囊 

Description for medicine or protocol of treatment in detail:

Flunarizine Hydrochloride Capsules from Chiatai Qingchunbao pharmaceutical Co., Ltd(T); Flunarizine Hydrochloride Capsules from Xian Janssen Pharmaceutical Ltd(R). 

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(包含 18 周岁和 45 周岁),男女均有; (2)体重:男性≥50 kg,女性≥45 kg;体重指数(BMI)在 19.0~26.0 kg/m2,包括边 界值; (3)体格检查、生命体征、12-导联心电图、胸部 X 线、实验室检查重要指标均为正 常或异常无临床意义者; (4)必须同意在研究期间以及末次研究药物给药后 6 个月内持续采取有效的避孕措 施且并无捐献精子、捐赠卵子(卵细胞、卵母细胞)计划; (5)受试者能够和研究者进行良好的沟通,并且理解和遵守本项研究的各项要求,并能按规定入住 I 期研究病房者; (6)充分了解本试验的目的和要求,自愿参加临床试验并签署书面知情同意书。  

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. agreed to continue to take effective contraceptive measures during the study period and within 6 months after the last study drug administration, and there is no plan to donate sperm and eggs (oocytes, oocytes). 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. 6. subjects have a fair understanding of the purpose, property, progress and adverse event that may happen, and volunteer to sign the ICF. 

排除标准:

(1)已知对试验制剂及其任何成分或相关制剂有过敏史、有过敏性疾患或过敏体质者; (2)当前具有临床显著性意义的疾病或具有临床显著性意义的病史(包括但不限于):心律失常或其他心脏病、血液疾病、凝血异常(包括所有异常出血或血液恶液质)、胃肠道疾病、脂质异常、显著性肺部疾病、支气管痉挛性呼吸疾病,糖尿病、肾脏或肝脏功能损害,甲状腺疾病、神经性疾病或精神性疾病、感染、或任何其他研究者认 为应当排除受试者的疾病或有可能会干扰研究结果解释的疾病; (3)试验前 30天内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; (4)在第一次服用研究药物之前 3 个月内有捐献血液或血液制品或大量失血(超过 400 mL)的经历,或者计划在研究期间捐献血液或血液制品; (5)在计划进行第一次研究药物给药前 14 天服用任何处方或非处方药物(包括维生 素和植物性营养补充剂, 如贯叶连翘(圣约翰草)。口服避孕药,扑热息痛(对乙 酰氨基酚)和持续使用的激素(宫内避孕器除外); (6)试验前 3 个月内参加过其他药物临床试验者; (7)现阶段或曾经是毒品吸食者或酒精成瘾者,筛选前 3 个月内经常饮酒者,即每 周饮酒超过 14 单位酒精(1 单位=17.7 mL 乙醇,即 1 单位=357 mL 酒精量为 5%的啤酒或 44 mL 酒精量为 40%的烈酒或 147 mL 酒精量为 12%的葡萄酒)。 (8)既往长期饮用过量(一天 8 杯以上,1 杯=200 mL)茶、咖啡或含咖啡因的饮料 者;首次用药前 48 小时内,摄入任何含有咖啡因、酒精、黄嘌呤或葡萄柚成分等的 食物或饮料(如咖啡、浓茶、巧克力等)者; (9)筛选前 3 个月内每日吸烟多于 10 支者; (10)酒精呼气试验阳性或药物滥用筛查阳性者; (11)乙型肝炎表面抗原(HBsAg)、HCV 抗体、HIV 抗体或梅毒螺旋体抗体阳性者; (12)女性受试者已怀孕、哺乳或计划在研究期间或末次服药后 6 个月内怀孕者; (13)试验前 4 周内接受过外科手术,计划开展有可能会干扰本项研究结果的外科手 术或操作; (14)在饮水辅助下不能吞咽固体口服制剂; (15)不耐受静脉穿刺者; (16)研究者认为有不适合参加试验的其他因素者; (17)乳糖不耐受者。  

Exclusion criteria:

1. Subject allergic to the study drug or its ingredients; subject has history of allergy or belongs to allergic constitution; 2. 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; 3. subject had took drug that inhibits or induces liver metabolism in the past 3 months. (eg, inducerbarbital, carbamazepine, phenytoin, glucocorticoid, omeprazole; inhibitorSSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines) 4. those with a history of blood donation or acute blood loss in the first 3 months (400 mL) or who intend to donate blood within the research period; 5. Take any prescription or over-the-counter medication14 days prior to the planned first study drug administration. (including vitamins and botanical supplements such as St. John's wort (St. John's Wort)) Oral contraceptives, paracetamol (acetaminophen) and persistent use of hormones (except for intrauterine devices); 6. had participated in other drug clinical trials within the first 3 months; 7. At this stage or once addictted drug or alcohol, or cannot quit smoking during the study; subject drank frequently in the past 3 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); 8. Any long-term overdose (more than 8 cups a day, 1 cup = 200 mL) tea, coffee or caffeinated beverages; 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; 9. subject took over 10 cigarettes every day in the past 3 months. 10. Those who have positive alcohol breath test or positive drug abuse screening; 11. One of HbsAg, HCV antibody, HIV antibody, syphilis turn out to be positive; 12. Female subjects have been pregnant, breast-feeding, or plan to become pregnant during the study period or within 6 months after the last dose; 13. Surgery within 4 weeks prior to the trial, plans to perform surgery that may interfere with the results of this study Surgery or operation; 14. Can not swallow solid oral preparations with water; 15. Intolerant venipuncture; 16. Subject insuitable to the study according to researchers. 17. Lactose intolerance. 

研究实施时间:

Study execute time:

From2019-10-03To 2020-04-01 

干预措施:

Interventions:

组别:

TR组

样本量:

33

Group:

TR group

Sample size:

干预措施:

第一阶段:T;第二阶段:R

干预措施代码:

Intervention:

Phase I: T; Phase II: R

Intervention code:

组别:

RT组

样本量:

33

Group:

RT group

Sample size:

干预措施:

第一阶段:R;第二阶段:T

干预措施代码:

Intervention:

Phase I: R; Phase II: T

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):

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:

三级甲等 

Institution
hospital:

The First 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:

正在进行

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):

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:

open label

Blinding:

open label

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:

 2019-10-19
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