中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500104046
最近更新日期： Date of Last Refreshed on：	2025-06-10 14:50:01
注册时间： Date of Registration：	2025-06-10 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	吡拉西坦片在健康受试者中随机、开放、单剂量、两制剂、两序列、两周期交叉空腹/餐后状态下的生物等效性试验
Public title：	Pharmacokinetics and Bioequivalence Evaluation of Piracetam Tablet: A Randomized, Single-Dose, Two-Period, Crossover Study in Healthy Chinese Subjects Under Fasting and Fed Conditions
注册题目简写：
English Acronym：
研究课题的正式科学名称：	吡拉西坦片在健康受试者中随机、开放、单剂量、两制剂、两序列、两周期交叉空腹/餐后状态下的生物等效性试验
Scientific title：	Pharmacokinetics and Bioequivalence Evaluation of Piracetam Tablet: A Randomized, Single-Dose, Two-Period, Crossover Study in Healthy Chinese Subjects Under Fasting and Fed Conditions
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：	晏和贵	研究负责人：	周铭
Applicant：	Yan Hegui	Study leader：	Zhou Ming
申请注册联系人电话： Applicant telephone：	+86 83602146	研究负责人电话： Study leader's telephone：	+86 156 2391 8122
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：	18184819378@163.com	研究负责人电子邮件： Study leader's E-mail：	2782044387@qq.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：	湖北省武汉市宝丰路28号	研究负责人通讯地址：	湖北省武汉市宝丰路28号
Applicant address：	28 Baofeng road, Qiaokou District, Wuhan, Hubei	Study leader's address：	28 Baofeng road, Qiaokou District, Wuhan, Hubei
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：	武汉市肺科医院
Applicant's institution：	Wuhan Pulmonary Hospital
研究负责人所在单位：	武汉市肺科医院
Affiliation of the Leader：	Wuhan Pulmonary Hospital

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：	(202(1))年临审第(019)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：	武汉市肺科医院药物临床试验伦理委员会
Name of the ethic committee：	The Ethics Committee of Wuhan Pulmonary Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2021-10-22 00:00:00
伦理委员会联系人：	陶军
Contact Name of the ethic committee：	Tao Jun
伦理委员会联系地址：	湖北省武汉市宝丰路28号
Contact Address of the ethic committee：	28 Baofeng road, Qiaokou District, Wuhan, Hubei
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 83613053	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：

武汉市肺科医院

Primary sponsor：

Wuhan Pulmonary Hospital

研究实施负责（组长）单位地址：

湖北省武汉市宝丰路28号

Primary sponsor's address：

28 Baofeng road, Qiaokou District, Wuhan, Hubei

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	山东省	市(区县)：
Country：	China	Province：	Shangdong	City：
单位(医院)：	华润双鹤利民药业（济南）有限公司	具体地址：	济南市章丘区明水街道利民路1号
Institution hospital：	China Resources Double-Crane Limin Pharmaceutical Co., Ltd.	Address：	1 Limin Road, Mingshui Avenue, Zhangqiu District, Jinan

经费或物资来源：

华润双鹤利民药业（济南）有限公司

Source(s) of funding：

China Resources Double-Crane Limin Pharmaceutical Co., Ltd.

研究疾病：

无

Target disease：

NA

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：

评价健康受试者空腹/餐后状态下，口服单剂量吡拉西坦片后，考察空腹和餐后条件下吡拉西坦片的药代动力学参数和个体内变异系数，验证血浆中药物浓度分析方法、采血时间、清洗期时间间隔等设置的合理性。

Objectives of Study：

The main purpose of this study was to evaluate the pharmacokinetics, bioequivalence and safety properties of piracetam tablet 800 mg in healthy Chinese subjects under fasting and fed conditions.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

排除标准：

（1）（问询）对吡拉西坦片或任意药物组分有过敏史者；或有过敏体质：如对某一种或多种药物、食物过敏者；或对同类药物有过敏史者；（2）（问询）在筛选前3个月内接受过手术，或者计划在研究期间进行手术者，及凡接受过会影响药物吸收、分布、代谢、排泄的手术者；（3）（问询）有临床表现异常需排除的疾病，包括但不限于神经系统、心血管系统、血液和淋巴系统、免疫系统、肾脏、肝脏、胃肠道、呼吸系统、代谢及骨骼等系统疾病者；（4）体格检查、胸部正位片、12-导联心电图或实验室检查异常者（经临床医师判断有临床意义）；（5）人免疫缺陷病毒抗体测定（HIV-Ab）、乙型肝炎表面抗原定量（HBsAg）、丙型肝炎病毒抗体定量（Anti-HCV）和梅毒螺旋体特异抗体（Anti-TP）结果一项或一项以上为阳性者；（6）（问询）筛选前3个月内每天吸烟大于5支者，或不同意在试验期间避免使用任何烟草类产品者；（7）（问询）在筛选前3个月内每天饮用过量茶、咖啡和/或富含咖啡因的饮料（8杯以上，1杯=250mL）或不同意在试验期间避免使用任何茶、咖啡和/或富含咖啡因类产品者；（8）（问询）筛选前3个月内每周饮酒量大于14单位（1单位酒精≈360mL啤酒或45mL酒精含量为40%的烈酒或150mL葡萄酒），或不同意在试验期间避免使用任何酒精类产品者；（9）（问询）试验前有特殊饮食和/或运动因素可能影响试验期间药物吸收、分布、代谢、排泄者，包括但不限于：筛选前7天内服用过有可能影响药物代谢的特殊饮食（包括火龙果、芒果、葡萄柚、酸橙、杨桃、巧克力或由其制备的食物或饮料者，或含咖啡因、黄嘌呤成分的饮食等）；或不同意在试验前48h内避免剧烈运动者；（10）（问询）筛选前3个月内献过血或失血≥200mL，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；（11）妊娠期、哺乳期或育龄期妇女筛选时尿妊娠检查结果为阳性者及试验期间不同意采取有效的避孕措施或其配偶计划在3个月内生育者；（12）（问询）筛选前2周内服用过任何研究者认为可能会影响研究药物药代动力学特征评价的药物（包括中药、功能性维生素、保健品、处方药、非处方药）者；（13）（问询）锥体外系疾病、Huntington舞蹈症、脑出血及凝血功能障碍患者；（14）（问询）筛选前1个月内使用过任何抑制或诱导肝脏药物代谢酶的药物（如：诱导剂-巴比妥类、卡马西平、苯妥英、糖皮质激素；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；（15）（问询）筛选前1个月内使用过任何与吡拉西坦片有相互作用的药物（如甲状腺激素、香豆素类抗凝血药物华法林等）；（16）筛选前28天内注射过疫苗者；（17）怀疑或确认筛选前1个月内有药物滥用史或使用过毒品者，或筛选期尿液成瘾药物（二亚甲基双氧安非他明（摇头丸）、甲基安非他明（冰毒）、氯胺酮、吗啡、四氢大麻酚酸（大麻）、可卡因）筛查试验阳性者；（18）不能耐受静脉穿刺者，有晕针晕血史者，或静脉采血困难者；（19）（问询）对饮食有特殊要求，不能接受统一饮食者（如不能耐受牛奶、鸡蛋、黄油、培根等食物者），或乳糖不耐受者（曾发生过喝牛奶腹泻者）；（20）（问询）筛选阶段或研究用药前发生急性疾病者；（21）筛选前3个月内参加过其他的药物临床试验或非本人来参加临床试验者；（22）研究者判断不适宜参加本项临床研究的受试者；

Exclusion criteria：

(1) (Inquiry) Those with a history of allergy to Piracetam Tablets or any of the drug components; or those with an allergic constitution, such as those allergic to one or more drugs, foods; or those with a history of allergy to drugs of the same class. (2) (Inquiry) Those who have undergone surgery within 3 months before screening, or those who plan to undergo surgery during the research period, and those who have undergone any surgery that may affect the absorption, distribution, metabolism, and excretion of the drug. (3) (Inquiry) Those with clinically abnormal manifestations that need to be excluded, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidneys, liver, gastrointestinal tract, respiratory system, metabolism, and skeletal system, etc. (4) Those with abnormal physical examination results, chest frontal radiograph results, 12-lead electrocardiogram results, or laboratory examination results (judged to be of clinical significance by a clinician). (5) Those with positive results in one or more of the tests for human immunodeficiency virus antibody (HIV-Ab), quantitative hepatitis B surface antigen (HBsAg), quantitative hepatitis C virus antibody (Anti-HCV), and specific antibody to Treponema pallidum (Anti-TP). (6) (Inquiry) Those who smoke more than 5 cigarettes per day within 3 months before screening, or those who do not agree to avoid using any tobacco products during the trial. (7) (Inquiry) Those who consume excessive amounts of tea, coffee, and/or caffeine-rich beverages (more than 8 cups, 1 cup = 250 mL) per day within 3 months before screening, or those who do not agree to avoid using any tea, coffee, and/or caffeine-rich products during the trial. (8) (Inquiry) Those who consume more than 14 units of alcohol per week within 3 months before screening (1 unit of alcohol ≈ 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine), or those who do not agree to avoid using any alcoholic products during the trial. (9) (Inquiry) Those with special dietary and/or exercise factors before the trial that may affect the absorption, distribution, metabolism, and excretion of the drug during the trial, including but not limited to those who have consumed special diets that may affect drug metabolism (including dragon fruit, mango, grapefruit, lime, carambola, chocolate or foods or beverages prepared from them, or diets containing caffeine, xanthine, etc.) within 7 days before screening; or those who do not agree to avoid strenuous exercise within 48 hours before the trial. (10) (Inquiry) Those who have donated blood or lost blood >= 200 mL within 3 months before screening, or those who plan to donate blood (including blood components) during the trial or within 3 months after the end of the trial. (11) Pregnant women, lactating women, or women of childbearing age with a positive urine pregnancy test result during screening, and those who do not agree to take effective contraceptive measures during the trial or whose spouses plan to have a baby within 3 months. (12) (Inquiry) Those who have taken any drugs (including traditional Chinese medicines, functional vitamins, health products, prescription drugs, over-the-counter drugs) that the researcher deems may affect the evaluation of the pharmacokinetic characteristics of the research drug within 2 weeks before screening. (13) (Inquiry) Patients with extrapyramidal diseases, Huntington's chorea, intracerebral hemorrhage, and coagulation disorders. (14) (Inquiry) Those who have used any drugs that inhibit or induce liver drug-metabolizing enzymes (such as inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines) within 1 month before screening. (15) (Inquiry) Those who have used any drugs that interact with Piracetam Tablets (such as thyroid hormones, coumarin anticoagulants like warfarin, etc.) within 1 month before screening. (16) Those who have received vaccination within 28 days before screening. (17) Those suspected or confirmed to have a history of drug abuse within 1 month before screening or those who have used drugs, or those with a positive result in the screening test for drugs of addiction in urine during the screening period (3,4-methylenedioxymethamphetamine (Ecstasy), methamphetamine (ice), ketamine, morphine, tetrahydrocannabinolic acid (marijuana), cocaine). (18) Those who cannot tolerate intravenous puncture, those with a history of fainting at the sight of needles or blood, or those with difficulty in venous blood collection. (19) (Inquiry) Those with special dietary requirements and who cannot accept the unified diet (such as those who cannot tolerate foods like milk, eggs, butter, bacon, etc.), or those with lactose intolerance (those who have had diarrhea after drinking milk). (20) (Inquiry) Those who develop an acute disease during the screening stage or before taking the research drug. (21) Those who have participated in other drug clinical trials within 3 months before screening or those who are not the actual subjects participating in the clinical trial. (22) Subjects whom the researcher deems unsuitable to participate in this clinical study.

研究实施时间：

Study execute time：

从 From 2021-11-26 00:00:00至 To 2021-12-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2021-11-26 00:00:00 至 To 2021-11-26 00:00:00

干预措施：

Interventions：

组别：	（空腹）T-R组	样本量：	14
Group：	(Fasting) T- R group	Sample size：	14
干预措施：	空腹试验中，受试者在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：	In fasting condition, subjects took the test preparation in the first cycle, and took the reference preparation in the second cycle	Intervention code：

组别：	（空腹）R-T组	样本量：	14
Group：	(Fasting) R-T group	Sample size：	14
干预措施：	空腹试验中，受试者在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：	In fasting condition, subjects took the reference preparation in the first cycle, and took the test preparation in the second cycle	Intervention code：

组别：	（餐后）T-R组	样本量：	14
Group：	(Fed) T-R group	Sample size：	14
干预措施：	餐后试验中，受试者在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：	In fed study, subjects took the test preparation in the first cycle, and took the reference preparation in the second cycle	Intervention code：

组别：	（餐后）R-T组	样本量：	14
Group：	(Fed) R-T group	Sample size：	14
干预措施：	餐后试验中，受试者在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：	In fed study, subjects took the reference preparation in the first cycle, and took the test preparation 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)：	湖北省	市(区县)：
Country：	China	Province：	Hubei	City：
单位(医院)：	武汉市肺科医院	单位级别：	三甲
Institution hospital：	Wuhan Pulmonary Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	峰浓度	指标类型：	主要指标
Outcome：	the maximum plasma concentration	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时刻到t时的药时曲线下面积	指标类型：	主要指标
Outcome：	the areas under the plasma concentration–time curve	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时刻到无穷时的药时曲线下面积	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：	消除终末端半衰期	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：

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	18	岁 years
最大 Max age	65	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）：

在研究中每名受试者接受受试制剂或参比制剂的顺序由随机分配表确定。随机分配表由统计单位应用SAS（9.4或以上版本）按1:1比例用区组随机法产生。在筛选时，每名受试者使用筛选号进行识别，以S+三位阿拉伯数字表示，如S001，每位进行筛选的受试者对应唯一的筛选号。试验的第-1天进行随机，每名合格的受试者按照筛选号从小到大获得随机号。空腹试验随机号以K+三位阿拉伯数字表示，如K001，餐后试验随机号以C+三位阿拉伯数字表示，如C001。

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

In the study, the order in which each subject receives the test preparation or the reference preparation is determined by the random allocation table. The random allocation table is generated by the statistical unit using the blocked randomization method in SAS (version 9.4 or above) at a ratio of 1:1. During the screening process, each subject is identified by a screening number, which is represented as S followed by three Arabic numerals, for example, S001. Each screened subject corresponds to a unique screening number. Randomization is carried out on Day -1 of the trial. Each eligible subject is assigned a random number in ascending order of the screening number. The random number for the fasting trial is represented as K followed by three Arabic numerals, such as K001, and the random number for the postprandial trial is represented as C followed by three Arabic numerals, such as C001.

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：

本次临床研究为开放性研究，除生物样本分析测试人员外，其他人员如临床研究者、项目管理人员、项目监查人员、数据管理及统计分析人员等均不设盲，分析测试人员采用盲态分析，在样本分析过程中不知道受试者每周期的给药制剂。

Blinding：

This clinical study is an open-label study. Except for the personnel conducting the analysis of biological samples, other personnel such as clinical researchers, project managers, project monitors, data management and statistical analysis personnel, etc., are not blinded. The analysis and testing personnel conduct the analysis in a blinded manner and are unaware of the administered preparations for each cycle of the subjects during the sample analysis process.

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）：	2027年后可向研究者获取，邮箱为：18184819378@163.com
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	You can obtain it from the researcher after 2027, email: 18184819378@163.com
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：	本次试验数据管理采用电子化数据管理系统（EDC）。 (1)数据管理计划：由数据管理员撰写，作为整个数据管理过程的指导性文件，数据管理所有过程均应按照其中定义的时间、内容及方法进行操作。 (2)电子病例报告表设计：根据方案要求设计数据采集表格，定义研究流程、数据表单名称及其收集的数据项，同时形成相应的eCRF填写指南，经申办方审查和批准后定稿。 (3)数据库建立与测试：数据库设计员根据纸质CRF设计eCRF，由数据管理员进行测试，测试内容包括：页面设计、访视期设置、访视中的录入表单顺序及每个数据点的顺序、不同用户浏览权限的准确性等等。 (4)逻辑核查规则建立与测试：逻辑核查为数据管理员针对数据库数据的完整性、一致性和准确性而进行的核查方式，可采用系统自动逻辑核查与人工逻辑核查两种方式。数据管理员结合EDC系统特点并根据项目实际要求进行逻辑程序的设计，数据录入同时EDC系统进行自动逻辑核查，实时发出系统疑问，除系统疑问外，数据管理员对文本数据进行人工核查，有问题发出人工疑问。逻辑核查测试由数据管理员根据数据核查计划完成，测试EDC系统能否按照预先设计准确执行质疑提示的触发和关闭，测试过程生成并保存有关文件存档。 (5)EDC系统用户权限：所有使用EDC系统的人员应该按照各自的角色获得EDC系统培训，签署培训记录后方可开通系统权限。 (6)数据录入：研究人员需按照GCP和研究方案要求来收集受试者数据，同时依据填写指南准确、及时、完整、规范地填写eCRF，eCRF不作为原始记录。 (7)源数据现场核查（SDV）：监查员在中心研究现场登陆EDC，核对eCRF数据与源数据的一致性，发现问题可随时在线发出疑问。 (8)疑问解答：研究者可实时在线解答疑问。数据管理员和监查员对研究者解答疑问进行批复，必要时可再次发出疑问，直到数据“清洁”。 (9)外部数据管理：外部数据根据外部数据传输协议进行管理。 (10)医学编码：本试验不良事件采用MedDRA字典进行编码。 (11)数据锁定及导出：所有受试者完成试验，病历全部录入系统，由主要研究者、申办者、统计分析人员和数据管理人员在数据审核并确认建立的数据库正确后，由数据管理员对数据进行锁定。数据全部锁定后，由数据管理员将其导入到指定数据库，交统计人员进行统计分析。锁定后的数据不可再编辑，数据锁定之后发现的问题，经确认后可在统计分析程序中修正。数据锁定后如有确切证据证明有必要解锁，研究者和申办方需签署相关文件。 (12)eCRF存档：试验结束，生成每个受试者的eCRF，PDF电子文档，刻录光盘保存。数据管理报告：试验结束后，数据管理员根据项目实际执行的情况撰写数据管理报告。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	This trial adopts an electronic data management system (EDC) for data management. (1) Data Management Plan: It is written by the data administrator and serves as a guiding document for the entire data management process. All processes of data management should be operated in accordance with the defined time, content and methods. (2)Design of Electronic Case Report Form: Design data collection forms according to the requirements of the protocol, define the research process, the names of data forms and the collected data items. Meanwhile, form corresponding eCRF filling guidelines, and finalize them after being reviewed and approved by the sponsor. (3)Establishment and Testing of the Database: The database designer designs the eCRF based on the paper CRF. The data administrator conducts tests, and the test contents include: page design, setting of the visit period, the order of the entry forms during the visit and the order of each data point, the accuracy of the browsing permissions for different users, etc. (4)Establishment and Testing of Logical Verification Rules: Logical verification is a verification method carried out by the data administrator for the integrity, consistency and accuracy of the data in the database, and it can adopt two methods: automatic system logical verification and manual logical verification. The data administrator designs the logical program in combination with the characteristics of the EDC system and according to the actual requirements of the project. When data are entered, the EDC system conducts automatic logical verification and issues system queries in real time. In addition to system queries, the data administrator conducts manual verification of the text data and issues manual queries if there are problems. The logical verification test is completed by the data administrator according to the data verification plan, and tests whether the EDC system can accurately execute the triggering and closing of the query prompts as designed in advance. The relevant documents generated during the test process shall be saved on file. (5) User Permissions of the EDC System: All personnel using the EDC system should receive EDC system training according to their respective roles, and the system permissions can be activated after signing the training records. (6) Data Entry: Researchers should collect the data of subjects according to the requirements of GCP and the research protocol, and fill in the eCRF accurately, timely, completely and standardly according to the filling guidelines. The eCRF does not serve as the original record. (7) Source Data Verification (SDV) on Site: The monitor logs in to the EDC at the central research site, checks the consistency between the data in the eCRF and the source data, and can issue queries online at any time if problems are found. (8) Question Answering: The researcher can answer the questions online in real time. The data administrator and the monitor approve the answers given by the researcher. If necessary, they can issue questions again until the data are "clean". (9) External Data Management: External data are managed according to the external data transmission protocol. (10) Medical Coding: The adverse events in this trial are coded using the MedDRA dictionary. (11) Data Locking and Export: After all subjects have completed the trial and all medical records have been entered into the system, the principal investigator, the sponsor, the statistical analyst and the data manager shall verify the database and confirm its correctness. Then the data administrator locks the data. After all data are locked, the data administrator imports them into the specified database and hands them over to the statistician for statistical analysis. The locked data cannot be edited any more. For the problems found after the data are locked, they can be corrected in the statistical analysis program after confirmation. If there is conclusive evidence that it is necessary to unlock the data after they are locked, the researcher and the sponsor need to sign the relevant documents. (12) Archiving of eCRF: After the trial is completed, generate the eCRF of each subject, save it as a PDF electronic document and burn it onto a CD for storage. Data Management Report: After the trial is completed, the data administrator writes a data management report according to the actual implementation situation of the project.
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2025-06-10 14:49:56