ChiCTR2500100306 版本V1.0 版本创建时间2025/04/07 17:50:40 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：

 ChiCTR2500100306 

最近更新日期：

Date of Last Refreshed on：

 2025-04-07 17:50:34 

注册时间：

Date of Registration：

 2025-04-07 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

氟比洛芬凝胶贴膏在健康受试者的生物等效性试验

Public title：

Bioequivalence Study of Flurbiprofen Cataplasms in Healthy Subjects

注册题目简写：

English Acronym：

研究课题的正式科学名称：

氟比洛芬凝胶贴膏在健康受试者的生物等效性试验

Scientific title：

Bioequivalence Study of Flurbiprofen Cataplasms in 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：

陈玲 

研究负责人：

段炼 

Applicant：

Chenling 

Study leader：

Daniel Duan 

申请注册联系人电话：

Applicant telephone：

 +86 181 8200 6260

研究负责人电话：

Study leader's
telephone：

+86 20 3919 5896

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：

 chenling@hz-pharm.com

研究负责人电子邮件：

Study leader's E-mail：

 danieldl@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：

湖南省长沙市高新区旺龙路136号万为科技产业园3栋

研究负责人通讯地址：

广州市海珠区昌岗东路250号

Applicant address：

No. 3, Wanwei Science and Technology Industrial Park, No.136 Wanglong Road, High-tech Zone, Changsha

Study leader's address：

250 Changgang East Road, Haizhu 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：

湖南慧泽生物医药科技有限公司

Applicant's institution：

HUNAN HUIZE BIOPHARM Co., LTD

研究负责人所在单位：

广州医科大学附属第二医院

Affiliation of the Leader：

Second Affiliated Hospital of Guangzhou Medical 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：

 Y2024-60-01

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：

广州医科大学附属第二医院临床试验伦理委员会

Name of the ethic committee：

Clinical Trial Ethics Committee of the Second Affiliated Hospital of Guangzhou Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-11-04 00:00:00

伦理委员会联系人：

杜潇潇

Contact Name of the ethic committee：

Du XiaoXiao

伦理委员会联系地址：

广州市海珠区昌岗东路250号

Contact Address of the ethic committee：

250 Changgang East Road, Haizhu District, Guangzhou

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 20 3415 3599

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 gyeyec@163.com

研究实施负责（组长）单位：

广州医科大学附属第二医院

Primary sponsor：

Second Affiliated Hospital of Guangzhou Medical University

研究实施负责（组长）单位地址：

广州市海珠区昌岗东路250号

Primary sponsor's address：

250 Changgang East Road, Haizhu 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

市(区县)：

Country：

China

Province：

Guangdong

City：

单位(医院)：

广州医科大学附属第二医院

具体地址：

广州市海珠区昌岗东路250号

Institution
hospital：

Second Affiliated Hospital of Guangzhou Medical University

Address：

250 Changgang East Road, Haizhu District, Guangzhou

经费或物资来源：

广东伊康纳斯生物医药科技股份有限公司

Source(s) of funding：

EQUINOX BIOTECH Co., LTD

研究疾病：

下述疾病及症状的镇痛、消炎：骨关节炎、肩周炎、肌腱和肌腱炎、腱鞘周围炎，肱骨外上髁炎（网球肘），肌肉疼痛，外伤所致肿胀、疼痛。  

Target disease：

Analgesia and anti-inflammatory of the following diseases and symptoms: osteoarthritis, scapulohumeral periarthritis, tendon and tendinitis, peritendinitis, external humeral epicondylitis (tennis elbow), muscle pain, swelling, pain caused by trauma.

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

研究设计：

随机交叉对照 

Study design：

Cross-over 

研究目的：

考察健康受试者单次贴敷1贴由广东伊康纳斯生物医药科技股份有限公司提供的氟比洛芬凝胶贴膏或Mikasa Seiyaku Co.,Ltd生产的氟比洛芬凝胶贴膏的药代动力学特征，评价两制剂的生物等效性和安全性，同时考察两制剂的粘附性，为该受试制剂注册申请提供依据。  

Objectives of Study：

To investigate the pharmacokinetic characteristics of single application of flurbiprofen gel paste provided by Guangdong Iconus Biomedical Technology Co., Ltd. or Flurbiprofen gel paste produced by Mikasa Seiyaku Co.,Ltd in healthy subjects, evaluate the bioequivalence and safety of the two preparations, and investigate the adhesion of the two preparations. To provide the basis for the application for registration of the tested preparation.

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)受试者必须在试验前对本试验知情同意、并对试验内容、过程及可能出现的不良反应充分了解，且自愿签署了书面的知情同意书；
2)受试者能够与研究者进行良好的沟通并能够依照方案规定完成试验；
3)性别：男性和女性；
4)年龄：18周岁及以上；
5）体重：男性体重≥50kg，女性体重≥45kg，且体重指数【BMI=体重（kg）/身高2（m2）】在19.0~26.0kg/m2范围内（含边界值）。

Inclusion criteria

1) The subject must give informed consent to the experiment before the experiment, fully understand the experiment content, process and possible adverse reactions, and voluntarily sign a written informed consent; 2) The subjects were able to communicate well with the researchers and complete the experiment according to the protocol; 3) Gender: male and female; 4) Age: 18 years old and above; 5) Weight: male weight >= 50kg, female weight >= 45kg, and body mass index [BMI= weight (kg)/height 2 (m2)] within the range of 19.0~26.0kg/m2 (including boundary value).

排除标准：

1)有过敏史（哮喘、荨麻疹、湿疹等）者，或已知对氟比洛芬等非甾体抗炎药及辅料中任何成分或医疗胶带、胶粘剂敷料或其他皮肤贴膏过敏者；
2)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；
3)患有胃肠痉挛、消化道溃疡、尿路梗塞、机械性肠梗阻、输尿管痉挛、胆道疾病、肝肾疾病或其他影响药物吸收或代谢的胃肠道及肝、肾疾病者；
4)有循环系统、内分泌系统、神经系统、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恶性肿瘤病史者或能干扰试验结果的任何其他疾病或生理情况者；
5)筛选前2周内使用过任何药物（包括处方药、非处方药、中草药、功能性维生素、保健品）； 6)筛选前30天内使用过强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、苯妥英钠、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；
6)筛选前30天内使用过强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、苯妥英钠、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；
7)筛选前3个月内使用过软毒品（如大麻）或筛选前1年内使用过硬毒品（如吗啡、甲基安非他明等）者；
8)筛选前6个月内接受过外科手术，或计划在研究期间进行外科手术者；
9)背部存在明显皮肤颜色差异、毛发过多、伤疤组织、纹身、涂色或伴有皮肤病者，如特应性状态、银屑病、白癜风或已知会改变皮肤外观或生理反应的疾病（如糖尿病、卟啉症）等，这些可能会干扰贴膏的贴敷或妨碍评价；
10)贴敷部位（背部）出现开放性创口；
11)给药前7天，贴敷部位（背部）使用局部用药物；
12)有阿司匹林哮喘（非甾体抗炎药等诱发的哮喘）的患者或有既往哮喘病史者；
13)筛选前3个月内献血或者其他原因大量失血超过200mL或使用血制品或输血者；
14)筛选前14天内注射疫苗者；
15)筛选前3个月内参加过其他临床试验并使用了试验用药品者；
16)有晕针史或不能耐受静脉穿刺采血者；
17)嗜烟者或平均每日吸烟量多于5支者，或不同意在住院期间避免使用任何烟草类产品者；
18)酗酒者或平均每周饮酒量超过14单位酒精（1单位=360mL酒精含量为5%的啤酒或44mL酒精量为40%的烈酒或150mL酒精含量为12%的葡萄酒）；
19)每天饮用过量茶、咖啡和/或含咖啡因的饮料8杯以上（1杯=250mL）或不同意住院期间禁止饮用咖啡和/或含咖啡因的饮料者；
20)不同意筛选当天至试验结束时避免食用西柚或含西柚的产品者；
21)筛选期间经体格检查、生命体征检查、心电图检查以及实验室检查包括血常规、尿常规、血生化、凝血功能、传染病四项检查异常有临床意义（以研究医生判断为准）者；
22)对饮食有特殊要求，不能遵守统一饮食者；
23)签署知情同意书开始至研究结束后3个月内有生育计划（包括捐精、捐卵计划），或不同意采取有效避孕方法（试验期间非药物）者；
24)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。
1.女性受试者除上述要求外，符合下列条件的也应排除： 25)筛选前30天内使用口服避孕药者； 26)筛选前6个月内使用长效雌激素或孕激素注射剂或埋植片者； 27)筛选前14天内与伴侣发生无避孕措施的性行为者； 28)血妊娠检查结果异常有临床意义者； 29)哺乳期者。
2.首次入住排除标准，符合下列条件之一也应排除： 1)入住研究室前24h内，吸烟量多于5支者； 2)入住呼气酒精测试阳性者； 3)入住尿液药物筛查结果阳性者； 4)入住生命体征测量异常有临床意义者； 5)入住研究室前24h内，饮用过量茶、咖啡和/或含咖啡因的饮料（8杯以上，1杯=250mL）者或入住前48h内食用西柚或西柚汁类产品或含罂粟的食物者； 6)筛选至入住当天，发生急性疾病者； 7)筛选至入住当天，使用过任何药物（包括处方药、非处方药或中草药、功能性维生素、保健品）者； 8)筛选至入住当天，发生过无保护措施性行为者； 9)筛选至入住当天，贴敷部位（背部）使用局部用药物者； 筛选至入住当天，贴敷部位（背部）出现破损、开放性创口者。

Exclusion criteria：

1) Have a history of allergy (asthma, urticaria, eczema, etc.), or are known to be allergic to any ingredient in non-steroidal anti-inflammatory drugs and excipients such as flurbiprofen or medical tape, adhesive dressing or other skin paste; 2) have any medical condition that increases the risk of bleeding, such as acute gastritis or active ulcers with bleeding, clinically significant thrombocytopenia or anemia, and have a history of active pathological bleeding or intracranial bleeding; 3) Patients with gastrointestinal spasm, gastrointestinal ulcer, urinary tract infarction, mechanical intestinal obstruction, ureteral spasm, biliary tract disease, liver and kidney disease or other gastrointestinal, liver and kidney diseases that affect drug absorption or metabolism; 4) Circulatory system, endocrine system, nervous system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities, or history of any clinical serious diseases or malignant tumors, or any other diseases or physiological conditions that can interfere with the test results; 5) Use of any drugs (including prescription drugs, over-the-counter drugs, Chinese herbs, functional vitamins, health products) within 2 weeks before screening; 6) Drugs that overstrongly inhibit or induce liver metabolism of drugs (such as: inducers - barbiturates, carbamazepine, phenytoin sodium, glucocorticoids, omeprazole) were used within 30 days before screening; Inhibitors -SSRI antidepressants, cimetidine, Diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines); 6) Drugs that overstrongly inhibit or induce liver metabolism of drugs (such as: inducers - barbiturates, carbamazepine, phenytoin sodium, glucocorticoids, omeprazole) were used within 30 days before screening; Inhibitors -SSRI antidepressants, cimetidine, Diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines); 7) Use of soft drugs (such as cannabis) within 3 months prior to screening or use of hard drugs (such as morphine, methamphetamine, etc.) within 1 year prior to screening; 8) Those who had undergone surgery within 6 months prior to screening or planned to undergo surgery during the study period; 9) Significant skin color differences on the back, excessive hair, scar tissue, tattoos, coloring, or accompanying skin diseases, such as atopic states, psoriasis, vitiligo, or diseases known to alter the appearance or physiological response of the skin (e.g., diabetes, porphyria), which may interfere with the application of the paste or hinder evaluation; 10) Open wound at the application site (back); 11) Apply topical medicine to the application site (back) for 7 days before administration; 12) Patients with aspirin asthma (asthma induced by non-steroidal anti-inflammatory drugs, etc.) or with a history of asthma; 13) People who donated blood or lost more than 200mL of blood for other reasons or used blood products or transfusions within 3 months before screening; 14) Those vaccinated within 14 days prior to screening; 15) Participants who have participated in other clinical trials and used investigational drugs within 3 months before screening; 16) Have a history of needle fainting or can not tolerate venous puncture blood collection; 17) Smokers or those who smoke more than 5 cigarettes per day on average, or those who do not agree to avoid the use of any tobacco products during hospitalization; 18) binge drinkers or those who consume an average of more than 14 units of alcohol per week (1 unit =360mL beer with 5% alcohol or 44mL spirits with 40% alcohol or 150mL wine with 12% alcohol); 19) Drink more than 8 cups of tea, coffee and/or caffeinated beverages per day (1 cup =250mL) or do not agree that coffee and/or caffeinated beverages should not be consumed during hospitalization; 20) Those who do not agree to avoid eating grapefruit or products containing grapefruit from the day of screening to the end of the trial; 21) During the screening period, physical examination, vital signs examination, electrocardiogram examination and laboratory examination, including blood routine, urine routine, blood biochemistry, coagulation function, infectious disease, four abnormal examinations have clinical significance (subject to the judgment of the study doctor); 22) Those who have special requirements for diet and cannot comply with a unified diet; 23) Signed informed consent from the beginning to the end of the study within 3 months after the birth plan (including sperm donation, egg donation plan), or do not agree to take effective contraceptive methods (non-drug during the trial); 24) Subjects who may not be able to complete the study for other reasons or who the investigator believes should not be included. 1.In addition to the above requirements, female subjects who meet the following conditions should also be excluded: 25) Oral contraceptives used within 30 days before screening; 26) Use of long-acting estrogen or progesterone injections or implants within 6 months before screening; 27) Those who had sex without contraception with their partner in the 14 days prior to screening; 28) Abnormal blood pregnancy test results have clinical significance; 29) Lactation. 2.First check-in exclusion criteria, meeting one of the following conditions should also be excluded: 1) Smoking more than 5 cigarettes within 24 hours before check-in; 2) Check in breath alcohol test positive; 3) Patients with positive urine drug screening results; 4) Patients with clinically significant abnormal vital signs; 5) Drink excessive tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250mL) within 24h before check-in, or eat grapefruit or grapefruit juice products or food containing opium poppy within 48h before check-in; 6) Screening of patients with acute illness until the day of check-in; 7) Those who have used any drugs (including prescription drugs, non-prescription drugs or Chinese herbs, functional vitamins, health care products) until the day of check-in; 8) Those who have had unprotected sex until the day of check-in; 9) Those who use topical drugs on the application area (back) until the day of check-in; Screened for patients with damaged or open wounds on the application site (back) on the day of check-in.

研究实施时间：

Study execute time：

从 From 2024-10-01 00:00:00至 To 2025-10-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-04-30 00:00:00 至 To 2025-05-30 00:00:00

干预措施：

Interventions：

组别：

A组

样本量：

 20

Group：

A

Sample size：

干预措施：

氟比洛芬凝胶贴膏，T-R

干预措施代码：

Intervention：

Flurbiprofen gel paste, T-R

Intervention code：

组别：

B组

样本量：

 20

Group：

B

Sample size：

干预措施：

氟比洛芬凝胶贴膏，R-T

干预措施代码：

Intervention：

Flurbiprofen gel paste, R-T

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

  

Country：

China

Province：

Guangdong

City：

单位(医院)：

 广州医科大学附属第二医院 

单位级别：

 三级甲等 

Institution
hospital：

Second Affiliated Hospital of Guangzhou Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

严重不良事件

指标类型：

次要指标

Outcome：

SAE

Type：

Secondary indicator

测量时间点：

试验过程至试验结束

测量方法：

通过临床实验室检查（血常规、血生化、尿常规）、妊娠检查（仅女性）、12导联心电图、生命体征监测、体格检查及计划外检查等反映记录

Measure time point of outcome：

Through trial process to the end of the Trial

Measure method：

Clinical laboratory examination (blood routine, blood biochemistry, urine routine), pregnancy examination (female only), 12-lead electrocardiogram, vital signs monitoring, physical examination and unscheduled examination were recorded

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：

给药前0h至给药后72h

测量方法：

采集各个时间点血液浓度计算

Measure time point of outcome：

0h before administration to 72h after administration

Measure method：

Blood concentration was collected and calculated at each time point

指标中文名：

AUC0-t

指标类型：

主要指标

Outcome：

AUC0-t：

Type：

Primary indicator

测量时间点：

给药前0h至给药后72h

测量方法：

自0时到最后一个浓度可准确测定的样品采集时间t的药物浓度-时间曲线下面积。采用线性梯形法计算：AUC(i, i+1)= (ti+1-ti)(Ci+Ci+1)/2，AUC为所有AUC(i, i+1)之和。

Measure time point of outcome：

0h before administration to 72h after administration

Measure method：

The area under the drug concentration-time curve from 0 to the last concentration that can be accurately measured at sample collection time t. The linear ladder method is used to calculate: AUC(i, i+1)= (ti+1-ti)(Ci+Ci+1)/2, where AUC is the sum of all AUC(i, i+1).

指标中文名：

AUC0-∞

指标类型：

主要指标

Outcome：

AUC0-∞

Type：

Primary indicator

测量时间点：

给药前0h至给药后72h

测量方法：

自0时至无穷的血浆药物浓度-时间曲线下面积。AUC0-∞=AUC0-t+Ct/λz，Ct是最后可测量的浓度，λz是末端相消除速率常数。

Measure time point of outcome：

0h before administration to 72h after administration

Measure method：

Area under the plasma drug concentration-time curve from 0 to infinite. AUC0-∞=AUC0-t+Ct/λz, where Ct is the last measurable concentration and λz is the end phase elimination rate constant.

指标中文名：

Tmax

指标类型：

次要指标

Outcome：

Tmax

Type：

Secondary indicator

测量时间点：

给药前0h至给药后72h

测量方法：

采集各个时间点血液浓度计算

Measure time point of outcome：

0h before administration to 72h after administration

Measure method：

Blood concentration was collected and calculated at each time point

指标中文名：

λz

指标类型：

次要指标

Outcome：

λz

Type：

Secondary indicator

测量时间点：

给药前0h至给药后72h

测量方法：

末端消除速率常数，将消除相血药浓度取对数，对时间作线性回归后所得斜率值的相反数为末端消除速率。

Measure time point of outcome：

0h before administration to 72h after administration

Measure method：

The end elimination rate constant is the logarithm of the blood drug concentration of the elimination phase, and the inverse of the slope value obtained by linear regression over time is the end elimination rate.

指标中文名：

T1/2z

指标类型：

次要指标

Outcome：

T1/2z

Type：

Secondary indicator

测量时间点：

给药前0h至给药后72h

测量方法：

按照Ln(2)/λz计算消除或终末半衰期。

Measure time point of outcome：

0h before administration to 72h after administration

Measure method：

The elimination or final half-life is calculated as Ln(2)/λz.

指标中文名：

AUC_%Extrap

指标类型：

次要指标

Outcome：

AUC_%Extrap

Type：

Secondary indicator

测量时间点：

给药前0h至给药后72h

测量方法：

AUC_%Extrap：[（AUC0-∞- AUC0-t）/ AUC0-∞]×100%，残留面积百分比。

Measure time point of outcome：

0h before administration to 72h after administration

Measure method：

AUC_%Extrap: [(AUC0-∞- AUC0-t)/AUC0-∞] x 100%, percentage of residual area.

指标中文名：

不良事件

指标类型：

次要指标

Outcome：

AE

Type：

Secondary indicator

测量时间点：

试验过程至试验结束

测量方法：

通过临床实验室检查（血常规、血生化、尿常规）、妊娠检查（仅女性）、12导联心电图、生命体征监测、体格检查及计划外检查等反映记录

Measure time point of outcome：

Through trial process to the end of the Trial

Measure method：

Clinical laboratory examination (blood routine, blood biochemistry, urine routine), pregnancy examination (female only), 12-lead electrocardiogram, vital signs monitoring, physical examination and unscheduled examination were recorded

指标中文名：

粘附情况评估

指标类型：

次要指标

Outcome：

Adhesion assessment

Type：

Secondary indicator

测量时间点：

用药后0h、2h、4h、6h、8h、10h、12h

测量方法：

每周期于贴敷用药后0h、2h、4h、6h、8h、10h、12h（揭除贴膏前）对贴膏的粘附情况进行评估

Measure time point of outcome：

0h, 2h, 4h, 6h, 8h, 10h, 12h after medication

Measure method：

The adhesive status of the paste was assessed at 0h, 2h, 4h, 6h, 8h, 10h, 12h (before removing the paste) after application of the paste every week

指标中文名：

皮肤反应评估

指标类型：

次要指标

Outcome：

Skin reaction assessment:

Type：

Secondary indicator

测量时间点：

用药后12h、12.5h、14h、24h、36h、48h和72h

测量方法：

皮肤反应评估：每周期于贴敷用药后12h、12.5h、14h、24h、36h、48h和72h对给药部位的皮肤反应进行评估

Measure time point of outcome：

12h, 12.5h, 14h, 24h, 36h, 48h and 72h after application

Measure method：

Skin reaction assessment: Skin reaction at the administration site was assessed weekly at 12h, 12.5h, 14h, 24h, 36h, 48h and 72h after application

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血浆

组织：

Sample Name：

Plasma

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：

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 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SAS软件（版本号：9.4或以上版本）产生的随机数初值种子参数需要保存。为确保在数据统计分析前，生物样本检测分析人员将不获得受试者分组信息及随机给药信息，受试者随机分组表由统计师在试验开始之前直接传递给临床研究中心。

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

The initial random number seed parameter generated by SAS software (version 9.4 or later) must be saved. To ensure that subject grouping and randomized dosing information would not be available to the bioassay analyst prior to statistical analysis of the data, the subject randomization table was passed directly to the clinical research Center by the statistician prior to the start of the trial.

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：

开放标签，对评估者隐藏分组

Blinding：

Open-label study with blinded-evaluators

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）：

不共享

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

None

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：

EDC

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

EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-04-07 17:50:34