ChiCTR2300073130 版本V1.0 版本创建时间2023/07/03 09:53:41 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2300073130 

最近更新日期：

Date of Last Refreshed on：

2023-07-03 09:53:17 

注册时间：

Date of Registration：

2023-07-03 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

氢溴酸右美沙芬片在中国健康受试者中单中心、随机、开放、单剂量、两制剂、两周期、两序列、双交叉、空腹/餐后状态下生物等效性试验

Public title：

Single center, randomized, open, single dose, two formulations, two cycles, two sequences, double crossover, fasting/postprandial bioequivalence trial of dexamethasone hydrobromide tablets in Chinese healthy subjects

注册题目简写：

English Acronym：

研究课题的正式科学名称：

氢溴酸右美沙芬片在中国健康受试者中单中心、随机、开放、单剂量、两制剂、两周期、两序列、双交叉、空腹/餐后状态下生物等效性试验

Scientific title：

Single center, randomized, open, single dose, two formulations, two cycles, two sequences, double crossover, fasting/postprandial bioequivalence trial of dexamethasone hydrobromide tablets in Chinese healthy subjects

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：

杨辉 

研究负责人：

杨辉 

Applicant：

Yang Hui 

Study leader：

Yang Hui 

申请注册联系人电话：

Applicant telephone：

+86 189 2023 8175

研究负责人电话：

Study leader's telephone：

+86 189 2023 8175

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：

py_gcp@126.com

研究负责人电子邮件：

Study leader's E-mail：

py_gcp@126.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：

广州市番禺区桥南街福愉东路8号

研究负责人通讯地址：

广州市番禺区桥南街福愉东路8号

Applicant address：

No. 8 Fuyu East Road, Qiaonan Street, Panyu District, Guangzhou

Study leader's address：

No. 8 Fuyu East Road, Qiaonan Street, Panyu District, Guangzhou

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：

广州市番禺区中心医院

Applicant's institution：

Guangzhou Panyu District Central Hospital

研究负责人所在单位：

广州市番禺区中心医院

Affiliation of the Leader：

Guangzhou Panyu District Central Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

PYZXYYEC[2023-011-01]

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：

广州市番禺区中心医院药物临床试验伦理委员会

Name of the ethic committee：

Ethics Committee for Clinical Trials of Drugs at Panyu District Central Hospital in Guangzhou City

伦理委员会批准日期：

Date of approved by ethic committee：

2023-05-29 00:00:00

伦理委员会联系人：

陈颖

Contact Name of the ethic committee：

Chen Ying

伦理委员会联系地址：

广州市番禺区桥南街福愉东路8号

Contact Address of the ethic committee：

No. 8 Fuyu East Road, Qiaonan Street, Panyu District, Guangzhou

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 20 3485 9967

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：

广州市番禺区中心医院

Primary sponsor：

Guangzhou Panyu District Central Hospital

研究实施负责（组长）单位地址：

广州市番禺区桥南街福愉东路8号

Primary sponsor's address：

No. 8 Fuyu East Road, Qiaonan Street, Panyu District, Guangzhou

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东省

市(区县)：

Country：

CHINA

Province：

Guangdong Province

City：

单位(医院)：

广州白云山光华制药股份有限公司

具体地址：

广州市海珠区南石路1号

Institution
hospital：

Guangzhou Baiyunshan Guanghua Pharmaceutical Co., Ltd

Address：

No.1 Nanshi Road, Haizhu District, Guangzhou City

经费或物资来源：

申办者

Source(s) of funding：

sponsor

Target disease：

cough

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 上市后药物 

Study phase：

4

研究设计：

随机交叉对照 

Study design：

Cross-over 

研究目的：

健康受试者空腹或餐后状态下，单次口服广州白云山光华制药股份有限公司生产的受试制剂氢溴酸右美沙芬片（规格：15mg）或Bayer Hispania, S.L.持证、DELPHARM EVREUX生产的参比制剂氢溴酸右美沙芬片（商品名：Romilar?；规格：15mg），分别考察空腹或餐后状态下受试制剂与参比制剂在健康受试者体内的药代动力学参数，评价两制剂的生物等效性。  

Objectives of Study：

Healthy subjects were given a single oral dose of the test formulation dexamethasone hydrobromide tablets (specification: 15mg) produced by Guangzhou Baiyunshan Guanghua Pharmaceutical Co., Ltd. on an empty stomach or in a postprandial state, or the reference formulation dexamethasone hydrobromide tablets (trade name: Romilar) produced by Bayer Hispania, S.L. and DELPHARM EVREUX ?; Specification: 15mg), to investigate the pharmacokinetic parameters of the test and reference formulations in healthy subjects under fasting or postprandial conditions, and to evaluate the bioequivalence of the two formulations.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1)充分了解试验目的、性质、方法以及可能发生的不良反应，自愿作为受试者，并在任何研究程序开始前由本人签署知情同意书且保证在整个试验过程中由本人参与试验； 2)年龄为18~55周岁（包含18周岁和55周岁）的男性或女性； 3)男性体重≥50.0kg，女性体重≥45.0kg；体重指数（BMI）在18.5~26.0kg/m2范围内（包括临界值，BMI=体重（kg）/身高（m2））； 4)在筛选期及未来3个月内无妊娠计划且自愿采取有效避孕措施（附录2）且无捐精、捐卵计划； 5)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者。

Inclusion criteria

1) Fully understand the purpose, nature, methods, and potential adverse reactions of the experiment, voluntarily act as a subject, and sign an informed consent form by myself before any research procedure begins, and ensure that I participate in the experiment throughout the entire process; 2) Male or female aged between 18 and 55 years old (including 18 and 55 years old); 3) Male weight ≥ 50.0kg, female weight ≥ 45.0kg; The body mass index (BMI) is within the range of 18.5-26.0kg/m2 (including the critical value, where BMI=weight (kg)/height (m2)); 4) During the screening period and within the next 3 months, there is no pregnancy plan and effective contraceptive measures are voluntarily taken (Appendix 2), and there is no plan to donate sperm or eggs; 5) Those who are able to communicate well with researchers and understand and comply with the requirements of this study.

排除标准：

1)对右美沙芬或制剂辅料（乳糖、微晶纤维素、玉米淀粉、滑石粉、硬脂酸镁）过敏者，或已知对任何药物、食物等过敏，或有特异性变态反应病史（如哮喘、风疹、湿疹性皮炎）或为严重的过敏体质，且经研究者判断有临床意义者； 2)有吞咽困难或任何影响药物吸收的胃肠道疾病史者； 3)存在任何血液循环系统、消化系统、泌尿系统、呼吸系统、神经系统、免疫系统、内分泌系统、精神异常或代谢异常等任何慢性或严重疾病史，或可能干扰试验结果的任何其他疾病，或3个月内的手术史； 4)既往有青光眼病史、哮喘病史或精神病史者； 5)患有任何增加出血性风险的疾病者，如急性胃炎或活动性溃疡伴出血、具有临床意义的血小板减少或贫血，以及有活动性病理性出血或有颅内出血病史者； 6)血管穿刺条件差，或不能耐受静脉穿刺者； 7)筛选前6个月内有药物滥用史者，或筛选前3个月内使用过毒品者，包括非医疗目的反复、大量地使用各类麻醉药品和精神药物，或尿液成瘾药物吗啡、甲基安非他明（冰毒）、氯胺酮、二亚甲基双氧安非他明（摇头丸）、四氢大麻酚酸（大麻）筛查试验任何一项或多项结果为阳性者； 8)筛选前3个月内参加过或正在参加其他的药物临床试验者； 9)筛选前3个月内献血包括成分血或大量失血（≥400mL），接受输血或使用血制品者；或打算在试验期间或试验结束后3个月内献血（包括血液成份）者； 10)筛选前14天内使用过任何处方药、非处方药、中草药和维生素者； 11)筛选前30天内服用过与氢溴酸右美沙芬存在相互作用的药物（包括但不限于NSAID COX 2抑制剂、抗心律失常药、单胺氧化酶抑制剂抗抑郁药、SSRI类抗抑郁剂、中枢神经系统抑制剂、祛痰药和粘液溶解剂、CYP2D6抑制剂）者； 12)筛选前3个月内接种过疫苗者，或计划在试验期间接种疫苗者； 13)筛选前3个月内每日吸烟量大于5支，或试验期间不能停止使用任何烟草类产品者； 14)筛选前3个月内酒精摄入量平均每天超过2个单位（1单位=360mL啤酒，或150mL红酒，或45mL蒸馏酒），或酒精呼气检测阳性者，或不同意在试验期间避免饮酒者； 15)在筛选前3个月内每天饮用过量浓茶、咖啡和/或含咖啡因的饮料（8杯以上，1杯=250mL）； 16)在服药前48h内摄取过浓茶、巧克力、咖啡或含咖啡因、含酒精、含黄嘌呤（如凤尾鱼、沙丁鱼、牛肝、牛肾等）、葡萄柚（汁）或西柚（汁）、橙子、火龙果、芒果、酸橙、杨桃的食物或饮料者； 17)对饮食有特殊要求，不能接受统一饮食（如不能耐受牛奶、鸡蛋、黄油、培根等食物）者； 18)体格检查、生命体征检查异常且由临床医师判断为有临床意义者； 19)实验室检查、12-导联心电图检查异常并经临床医师判断有临床意义者； 20)HIV抗体、乙肝病毒表面抗原、丙肝病毒抗体、梅毒螺旋体抗体任何一项或多项检查结果为阳性者； 21)女性处在妊娠期、哺乳期，或女性在计划给药前14天内有未保护性行为或血妊娠检查结果阳性者； 22)女性筛选前6个月内使用过长效雌激素和/或孕激素注射剂和/或埋植片或筛选前30天内使用过口服避孕药者； 23)在研究前筛选阶段或研究用药前发生急性疾病者； 24)其它研究者判定不适宜参加本项临床研究的受试者。

Exclusion criteria：

1) Individuals who are allergic to dextromethorphan or its excipients (lactose, microcrystalline cellulose, corn starch, talc powder, magnesium stearate), or are known to be allergic to any drug, food, or have a history of specific allergic reactions (such as asthma, rubella, eczema dermatitis), or have a severe allergic constitution, and have been determined by the researcher to have clinical significance; 2) Have a history of dysphagia or any gastrointestinal disease affecting absorption; 3) There is a history of any chronic or serious disease such as blood circulation system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, mental disorder or metabolic abnormality, or any other disease that may interfere with the test results, or a history of surgery within 3 months; 4) Previous history of glaucoma, asthma, or mental illness; 5) Individuals with any disease that increases the risk of bleeding, such as acute gastritis or active ulcer with bleeding, clinically significant thrombocytopenia or anemia, as well as those with active pathological bleeding or a history of intracranial hemorrhage; 6) Poor vascular puncture conditions or inability to tolerate venous puncture; 7) Individuals with a history of drug abuse within the first 6 months of screening, or those who have used drugs within the first 3 months of screening, including those who repeatedly and extensively use various types of narcotic drugs and psychotropic substances for non medical purposes, or have tested positive for any one or more of the urine addictive drugs such as morphine, methamphetamine (methamphetamine), ketamine, dimethylenedioxymethamphetamine (ecstasy), and tetrahydrocannabinoid acid (marijuana) screening tests; 8) Individuals who have participated or are currently participating in other drug clinical trials within the first 3 months of screening; 9) Blood donation within 3 months prior to screening, including component blood or significant blood loss (≥ 400mL), receiving blood transfusion or using blood products; Or those who plan to donate blood (including blood components) during or within 3 months after the experiment; 10) Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, and vitamins within the first 14 days of screening; 11) Those who have taken drugs that interact with dextromethorphan hydrobromide within 30 days before screening (including but not limited to NSAID COX 2 inhibitors, antiarrhythmic drugs, monoamine oxidase inhibitor antidepressants, SSRI antidepressants, central nervous system inhibitors, expectorants and mucolytic agents, CYP2D6 inhibitors); 12) Those who have received the vaccine within the first 3 months of screening, or those who plan to receive the vaccine during the trial period; 13) Those who smoke more than 5 cigarettes per day within the first 3 months of screening, or who cannot stop using any tobacco products during the trial period; 14) Individuals with an average daily alcohol intake exceeding 2 units (1 unit=360mL of beer, 150mL of red wine, or 45mL of distilled wine) or positive alcohol breath test results within the first 3 months of screening, or those who do not agree to avoid drinking during the trial period; 15) Drinking excessive amounts of strong tea, coffee, and/or caffeinated beverages (8 or more cups, 1 cup=250mL) every day for the first 3 months prior to screening; 16) Those who have taken strong tea, chocolate, coffee or food or drink containing caffeine, alcohol, xanthine (such as anchovy, sardine, beef liver, beef kidney, etc.), grapefruit (juice) or grapefruit (juice), orange, pitaya, mango, lime, carambola within 48 hours before taking the medicine; 17) Those who have special dietary requirements and cannot accept a unified diet (such as intolerance to foods such as milk, eggs, butter, bacon, etc.); 18) Those whose physical examination and vital sign examination are abnormal and judged by clinicians to be clinically significant; 19) Laboratory examination, 12-lead electrocardiogram examination with abnormalities and clinical significance determined by clinical physicians; 20) HIV antibody, hepatitis B virus surface antigen, hepatitis C virus antibody and treponema pallidum antibody are positive in any one or more tests; 21) Women who are in pregnancy, lactation, or have unprotected sexual activity or positive blood pregnancy test results within 14 days before the planned medication administration; 22) Women who have used long-term estrogen and/or progesterone injections and/or implants within 6 months before screening, or who have used oral contraceptives within 30 days before screening; 23) Those who develop acute diseases during the pre study screening stage or before the study medication; 24) Subjects deemed unsuitable by other researchers to participate in this clinical study.

研究实施时间：

Study execute time：

从 From 2023-07-01 00:00:00至 To 2023-10-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-07-03 00:00:00 至 To 2023-07-07 00:00:00  

干预措施：

Interventions：

组别：

空腹A组

样本量：

20

Group：

Fasting Group A

Sample size：

干预措施：

第一周期服用受试制剂，第二周期服用参比制剂

干预措施代码：

Intervention：

Take the test formulation in the first cycle and the reference formulation in the second cycle

Intervention code：

组别：

空腹B组

样本量：

20

Group：

Fasting Group B

Sample size：

干预措施：

第一周期服用参比制剂，第二周期服用受试制剂

干预措施代码：

Intervention：

Take the reference formulation in the first cycle and the test formulation in the second cycle

Intervention code：

组别：

餐后A组

样本量：

18

Group：

Postprandial Group A

Sample size：

干预措施：

第一周期服用受试制剂，第二周期服用参比制剂

干预措施代码：

Intervention：

Take the test formulation in the first cycle and the reference formulation in the second cycle

Intervention code：

组别：

餐后B组

样本量：

18

Group：

Postprandial Group B

Sample size：

干预措施：

第一周期服用参比制剂，第二周期服用受试制剂

干预措施代码：

Intervention：

Take the reference formulation in the first cycle and the test formulation in the second cycle

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

  

Country：

China 

Province：

Guangdong Province 

City：

 

单位(医院)：

广州市番禺区中心医院 

单位级别：

三甲 

Institution
hospital：

Guangzhou Panyu District Central Hospital

Level of the institution：

Trimethylamine

测量指标：

Outcomes：

指标中文名：

峰浓度

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：

从0时到外推至无穷远时间的曲线下面积

指标类型：

主要指标

Outcome：

AUC0-∞

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

达峰时间

指标类型：

主要指标

Outcome：

Tmax

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

半衰期

指标类型：

主要指标

Outcome：

t1/2

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

末端消除速率

指标类型：

主要指标

Outcome：

λz

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不良事件

指标类型：

次要指标

Outcome：

adverse event

Type：

Secondary 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 岁 years
最大 Max age 55 岁 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）：

由统计单位应用SAS（9.4或更高版本）用区组随机法生成随机分配表。

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

Generate a random allocation table using the block randomization method using SAS (version 9.4 or higher) applied by statistical units.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

在研究分析阶段参与样本分析的研究人员应对样本保持盲法分析，也即参与样本分析的研究人员将对随机分配表不知情。

Blinding：

Researchers participating in sample analysis during the research analysis phase should maintain blind analysis of the samples, meaning that researchers participating in sample analysis will be unaware of the random allocation table.

是否共享原始数据：

IPD sharing

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）：

向研究者索要结果 请阅读网页注册指南中关于 原始数据共享 的内容 (http://www.medresman.org.cn/admin/index.aspx)

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

To request results from researchers, please read the content on raw data sharing in the webpage registration guide( http://www.medresman.org.cn/admin/index.aspx )

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：

病例记录表

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

Case Record Form

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：

  2023-07-03 09:53:17