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己酮可可碱缓释片在健康试验参与者中单中心、开放、随机、单剂量、双周期、双交叉空腹和餐后状态下的生物等效性预试验
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注册号：

Registration number：

 ChiCTR2600121766 

最近更新日期：

Date of Last Refreshed on：

 2026-04-02 16:16:42 

注册时间：

Date of Registration：

 2026-04-02 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

己酮可可碱缓释片在健康试验参与者中单中心、开放、随机、单剂量、双周期、双交叉空腹和餐后状态下的生物等效性预试验

Public title：

A single-center, open-label, randomized, single-dose, two-period, two-way crossover bioequivalence pre-trial of pentoxifylline sustained-release tablets under fasting and postprandial conditions in healthy test subjects

注册题目简写：

English Acronym：

研究课题的正式科学名称：

己酮可可碱缓释片在健康试验参与者中单中心、开放、随机、单剂量、双周期、双交叉空腹和餐后状态下的生物等效性预试验

Scientific title：

A single-center, open-label, randomized, single-dose, two-period, two-way crossover bioequivalence pre-trial of pentoxifylline sustained-release tablets under fasting and postprandial conditions in healthy test 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 20 3485 9951

研究负责人电话：

Study leader's
telephone：

+86 20 3485 9951

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：

 yanghui1234359@sina.com

研究负责人电子邮件：

Study leader's E-mail：

 yanghui1234359@sina.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：

广东省广州市番禺区桥南街福愉东路8号

研究负责人通讯地址：

广东省广州市番禺区桥南街福愉东路8号

Applicant address：

No. 8, Fuyu East Road, Qianan Street, Panyu District, Guangzhou City, Guangdong Province

Study leader's address：

No. 8, Fuyu East Road, Qianan Street, Panyu District, Guangzhou City, Guangdong Province

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：

广州医科大学附属番禺中心医院

Applicant's institution：

The Affiliated Panyu Central Hospital, Guangzhou Medical University

研究负责人所在单位：

广州医科大学附属番禺中心医院

Affiliation of the Leader：

The Affiliated Panyu Central Hospital, 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：

 PYZXYYEC【2026-005（YW）】-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：

广州医科大学附属番禺中心医院药物临床试验伦理委员会

Name of the ethic committee：

Drug Clinical Trial Ethics Committee of Panyu Central Hospital Affiliated to Guangzhou Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-02-02 00:00:00

伦理委员会联系人：

冯富肩

Contact Name of the ethic committee：

Feng Fujian

伦理委员会联系地址：

广东省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, Qianan Street, Panyu District, Guangzhou City, Guangdong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 20 34859967

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 531177697@qq.com

研究实施负责（组长）单位：

广州医科大学附属番禺中心医院

Primary sponsor：

The Affiliated Panyu Central Hospital, Guangzhou Medical University

研究实施负责（组长）单位地址：

广东省广州市番禺区桥南街福愉东路8号

Primary sponsor's address：

No. 8, Fuyu East Road, Qianan Street, Panyu District, Guangzhou City, Guangdong Province

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

City：

单位(医院)：

广州医科大学附属番禺中心医院

具体地址：

广东省广州市番禺区桥南街福愉东路8号

Institution
hospital：

The Affiliated Panyu Central Hospital, Guangzhou Medical University

Address：

No. 8, Fuyu East Road, Qianan Street, Panyu District, Guangzhou City, Guangdong Province

经费或物资来源：

烟台鲁银药业有限公司

Source(s) of funding：

Yantai Luyin Pharmaceutical Co., Ltd.

研究疾病：

无  

Target disease：

None

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：

比较空腹和餐后给药条件下，烟台鲁银药业有限公司提供的己酮可可碱缓释片（0.4g）与Neuraxpharm UK Limited持证的己酮可可碱缓释片（400mg，商品名：Trental®）在健康成年人群中吸收程度和速度的差异，考察药物的体内药代动力学特征，为能否进入正式试验提供决策依据，并验证正式试验样本量、采血点、试验周期间隔及分析方法等设置的合理性。评价空腹和餐后给药条件下，烟台鲁银药业有限公司提供的己酮可可碱缓释片（0.4g）与Neuraxpharm UK Limited持证的己酮可可碱缓释片（400mg，商品名：Trental®）的安全性。  

Objectives of Study：

By comparing the absorption levels and rates of the ketoconazole sustained-release tablets (0.4g) provided by Yantai Lu Yin Pharmaceutical Co., Ltd. and the ketoconazole sustained-release tablets (400mg, trade name: Trental®) certified by Neuraxpharm UK Limited under fasting and post-meal administration conditions in healthy adult populations, the study examines the in vivo pharmacokinetic characteristics of the drug, provides a basis for decision-making on whether to proceed to the formal trial, and verifies the rationality of the settings for the sample size, blood collection points, trial cycle intervals, and analysis methods in the formal trial.To evaluate the safety of the ketoconazole sustained-release tablets (0.4g) provided by Yantai Lu Yin Pharmaceutical Co., Ltd. under fasting and post-meal administration conditions, and the ketoconazole sustained-release tablets (400mg, trade name: Trental®) certified by Neuraxpharm UK Limited.

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、查询）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；以及已知或怀疑对己酮可可碱或其辅料过敏者，或已知对甲基黄嘌呤类药物过敏者； 2.（问询）有吞咽困难者； 3.（问询、查询）存在研究医生判定有临床意义的血液循环系统、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慢性病史或严重疾病史（如：已知的脑出血、广泛性视网膜出血、严重心律失常、急性心肌梗塞等），或可能干扰试验结果的任何其他疾病者； 4.（问询）筛选前经历过经研究者判断会影响药物吸收、分布、代谢、排泄的手术，或3个月内的手术史；或计划在研究期间至研究结束后1周内进行手术者； 5.（检查）血管穿刺条件差； 6.（问询）不能耐受静脉穿刺者，或有晕针晕血史者； 7.（问询、检查）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，或药物滥用筛查[包括：吗啡、二亚甲基双氧安非他明、甲基安非他明、氯胺酮、四氢大麻酚酸]任何一项或多项结果为阳性者； 8.（问询、联网筛查）筛选前3个月内参加过或正在参加其它临床试验并使用过试验用药品或医疗器械干预者； 9.（问询）筛选前3个月内献血包括成分血或大量失血（>=400mL）（女性生理性失血除外），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.（问询、检查）女性处在妊娠期、哺乳期，或女性在筛选前14天内有未保护性行为或血妊娠检查结果阳性，或女性在筛选前30天内使用口服避孕药，或女性筛选前6个月内使用长效雌激素或孕激素注射剂（含孕激素型宫内节育器）或埋植片者； 11.（问询、查询）筛选前14天内使用过任何处方药、非处方药、中草药、保健品和维生素者； 12.（问询）筛选前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、苯妥英钠、利福平等；抑制剂—SSRI类抗抑郁药、西咪替丁、环孢素、大环内酯类、维拉帕米、喹诺酮类、吡咯类抗真菌药、HIV蛋白酶抑制剂等）者； 13.（问询、查询）筛选前3个月内接受过疫苗接种者，或计划在试验期间接种疫苗者； 14.（问询）筛选前3个月内每日吸烟量大于5支，或首次给药前48h内和整个试验期间不能停止使用任何烟草类产品者，包括任何包含尼古丁的戒烟产品； 15.（问询、检查）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； 16.（问询）在首次给药前48h内摄取了或试验期间无法停止摄取含咖啡因、酒精类等饮料（包括巧克力、茶、咖啡、可乐等），食用葡萄柚或葡萄柚产品以及火龙果、芒果、柚子、橘子等影响药物代谢的食物者； 17.（问询）对饮食有特殊要求，不能接受统一饮食者； 18.（问询）乳糖及半乳糖不耐受者（曾发生过喝牛奶腹泻者）； 19.在研究前筛选阶段或研究用药前发生急性疾病者； 20.其它研究者认为存在不适合参加的情况（如依从性差、心理状态不稳定），因自身原因不能参加试验者

Exclusion criteria：

1.(Inspection, inquiry) Those who are known to be allergic to any drugs, foods, etc., or have a history of specific allergic reactions (such as asthma, measles, eczema), or are of a severe allergic constitution, and whose condition has been judged by the investigator to be clinically significant; as well as those who are known or suspected to be allergic to pentoxifylline or its excipients, or who are known to be allergic to methylxanthine drugs. 2.(Asking) Those who have difficulty in swallowing; 3.(Enquiry, Query) Individuals with a history of chronic diseases or serious illnesses as determined by the research doctor, which may include conditions such as circulatory system disorders, digestive system disorders, urinary system disorders, respiratory system disorders, nervous system disorders, immune system disorders, endocrine system disorders, mental abnormalities or metabolic abnormalities (e.g., known cerebral hemorrhage, extensive retinal hemorrhage, severe arrhythmia, acute myocardial infarction, etc.), or any other diseases that may interfere with the test results are eligible. 4.(Enquiry) Exclude those who have undergone surgeries that, based on the researcher's judgment, would affect the absorption, distribution, metabolism, and excretion of the drug; or those with a history of surgery within the past 3 months; or those who plan to undergo surgery during the study period or within one week after the study concludes. 5.(The) Vascular puncture conditions are poor. 6.(Enquiry) For those who cannot tolerate venipuncture, or those with a history of fainting or experiencing bleeding during injections; 7.(For inquiry and examination) Screen those who have a history of drug abuse within the past 6 months, or those who have used drugs within the past 3 months, including those who have repeatedly and in large quantities used various anesthetic drugs and psychotropic drugs for non-medical purposes, or those whose results of drug abuse screening (including: morphine, dimethylaminoamphetamine, methamphetamine, ketamine, tetrahydrocannabinolic acid) are positive for any one or more items. 8.(Inspection, network screening) Those who have participated in or are currently participating in other clinical trials within the past 3 months and have used the investigational drugs or medical devices for intervention. 9.(Enquiry) Those who have donated blood within the past 3 months, including whole blood or significant blood loss (>= 400 mL) (excluding physiological blood loss in women), have received blood transfusions or used blood products; or those who plan to donate blood (including blood components) within 3 months during the trial or after the trial is over. 10.(Inspection, examination) Women who are pregnant, breastfeeding, or had unprotected sexual intercourse within 14 days before the screening, or whose blood pregnancy test result was positive, or who used oral contraceptives within 30 days before the screening, or who used long-acting estrogen or progesterone injections (including progestin-type intrauterine devices) or implants within 6 months before the screening. 11.(For inquiry or query) Those who have used any prescription drugs, over-the-counter drugs, herbal medicines, health supplements or vitamins within the past 14 days; 12.(Enquiry) Those who have used any drugs that inhibit or induce the liver's metabolism of drugs within the past 30 days (such as inducers - barbiturates, carbamazepine, phenytoin, rifampicin, etc.; inhibitors - SSRI anti-depressants, cimetidine, cyclosporine, macrolides, verapamil, quinolones, pyrimidine antifungal drugs, HIV protease inhibitors, etc.); 13.(For inquiry or search) Select those who have received vaccinations within the past three months, or those who plan to receive vaccinations during the trial period. 14.(Enquiry) Those who have smoked more than 5 cigarettes per day for the previous 3 months, or who were unable to stop using any tobacco products during the 48 hours before the first administration and throughout the entire trial period, including any nicotine-containing smoking cessation products. 15.(Examination and inquiry) Screening for individuals whose average alcohol intake over the past 3 months exceeded 2 units per day (1 unit = 360 mL of beer, or 150 mL of red wine, or 45 mL of distilled spirits), or those with a positive alcohol breath test result, or those who do not agree to abstain from alcohol consumption during the trial period. 16.(Enquiry) Individuals who consumed beverages containing caffeine, alcohol (including chocolate, tea, coffee, cola, etc.) within 48 hours before the first administration, or who were unable to stop consuming such beverages during the trial, those who consumed grapefruit or grapefruit products, as well as foods that affect drug metabolism such as dragon fruit, mango, grapefruit, and oranges; 17.(Enquiry) Those who have special dietary requirements and cannot accept the uniform diet. 18.(Enquiry) Individuals with lactose and galactose intolerance (those who have experienced diarrhea after drinking milk); 19.Those who developed acute diseases during the pre-study screening phase or before the administration of the study medication; 20.Other researchers believe that there are certain circumstances that make participation inappropriate (such as poor compliance and unstable mental state), and individuals who cannot participate in the trial due to their own reasons.

研究实施时间：

Study execute time：

从 From 2026-03-26 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-04-02 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：

R-T组

样本量：

 12

Group：

R-T group

Sample size：

干预措施：

空腹给药试验： 第 一 周 期 6 例 试 验 参 与 者 空 腹 口 服 受 试 制 剂 （ T ） 1 片（0.4g），整片吞服，约240mL温水送服，服药前后1h内禁水（服药用水除外）；另外6例试验参与者空腹口服参比制剂（R）1片（400mg），整片吞服，约240mL温水送服，服药前后1h内禁水（服药用水除外）。7天后交叉给药。 餐后给药试验：第一周期6例试验参与者进食高脂餐后，自进食高脂餐开始计时的30+/-0.5min内开始口服受试制剂（T）1片（0.4g），整片吞服，约240mL 温水送服，用餐前1h至服药后1h内禁水（服药用水和高脂餐谱中的饮品除外）；另外6例试验参与者进食高脂餐后，自进食高脂餐开始计时的30+/-0.5min内开始 口服参比制剂（R）1片（400mg），整片吞服，约240mL温水送服，用餐前1h至服药后1h内禁水（服药用水和高脂餐谱中的饮品除外）。7天后交叉给药。

干预措施代码：

Intervention：

Fast-fasting administration test: During the first cycle, 6 participants in the test group took 1 tablet (0.4g) of the test formulation (T) orally on an empty stomach, swallowing it whole and taking it with approximately 240mL of warm water. They were instructed to refrain from drinking water within 1 hour before and after taking the medication (except for the water used for taking the medication). The other 6 participants also took 1 tablet (400mg) of the reference formulation (R) orally on an empty stomach, swallowing it whole and taking it with approximately 240mL of warm water. They were also instructed to refrain from drinking water within 1 hour before and after taking the medication (except for the water used for taking the medication and the beverages in the high-fat meal recipe). After 7 days, the administration was switched. Post-meal administration test: During the first cycle, 6 participants in the test group took 1 tablet (0.4g) of the test formulation (T) orally within 30 +/- 0.5 minutes after consuming a high-fat meal. They swallowed it whole and took it with approximately 240mL of warm water. They were instructed to refrain from drinking water from 1 hour before the meal to 1 hour after taking the medication (except for the water used for taking the medication and the beverages in the high-fat meal recipe). The other 6 participants also took 1 tablet (400mg) of the reference formulation (R) orally within 30 +/- 0.5 minutes after consuming a high-fat meal. They swallowed it whole and took it with approximately 240mL of warm water. They were also instructed to refrain from drinking water from 1 hour before the meal to 1 hour after taking the medication (except for the water used for taking the medication and the beverages in the high-fat meal recipe). After 7 days, the administration was switched.

Intervention code：

组别：

T-R组

样本量：

 12

Group：

T-R group

Sample size：

干预措施：

空腹给药试验： 第 一 周 期 6 例 试 验 参 与 者 空 腹 口 服 受 试 制 剂 （ T ） 1 片（0.4g），整片吞服，约240mL温水送服，服药前后1h内禁水（服药用水除外）；另外6例试验参与者空腹口服参比制剂（R）1片（400mg），整片吞服，约240mL温水送服，服药前后1h内禁水（服药用水除外）。7天后交叉给药。 餐后给药试验：第一周期6例试验参与者进食高脂餐后，自进食高脂餐开始计时的30+/-0.5min内开始口服受试制剂（T）1片（0.4g），整片吞服，约240mL 温水送服，用餐前1h至服药后1h内禁水（服药用水和高脂餐谱中的饮品除外）；另外6例试验参与者进食高脂餐后，自进食高脂餐开始计时的30+/-0.5min内开始 口服参比制剂（R）1片（400mg），整片吞服，约240mL温水送服，用餐前1h至服药后1h内禁水（服药用水和高脂餐谱中的饮品除外）。7天后交叉给药。

干预措施代码：

Intervention：

Fast-fasting administration test: During the first cycle, 6 participants in the test group took 1 tablet (0.4g) of the test formulation (T) orally on an empty stomach, swallowing it whole and taking it with approximately 240mL of warm water. They were instructed to refrain from drinking water within 1 hour before and after taking the medication (except for the water used for taking the medication). The other 6 participants also took 1 tablet (400mg) of the reference formulation (R) orally on an empty stomach, swallowing it whole and taking it with approximately 240mL of warm water. They were also instructed to refrain from drinking water within 1 hour before and after taking the medication (except for the water used for taking the medication and the beverages in the high-fat meal recipe). After 7 days, the administration was switched. Post-meal administration test: During the first cycle, 6 participants in the test group took 1 tablet (0.4g) of the test formulation (T) orally within 30 +/- 0.5 minutes after consuming a high-fat meal. They swallowed it whole and took it with approximately 240mL of warm water. They were instructed to refrain from drinking water from 1 hour before the meal to 1 hour after taking the medication (except for the water used for taking the medication and the beverages in the high-fat meal recipe). The other 6 participants also took 1 tablet (400mg) of the reference formulation (R) orally within 30 +/- 0.5 minutes after consuming a high-fat meal. They swallowed it whole and took it with approximately 240mL of warm water. They were also instructed to refrain from drinking water from 1 hour before the meal to 1 hour after taking the medication (except for the water used for taking the medication and the beverages in the high-fat meal recipe). After 7 days, the administration was switched.

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

City：

单位(医院)：

 广州医科大学附属番禺中心医院 

单位级别：

 三级甲等 

Institution
hospital：

The Affiliated Panyu Central Hospital, Guangzhou Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

从0时到无限时间（∞）的药物浓度-时间曲线下面积

指标类型：

主要指标

Outcome：

The area under the drug concentration-time curve from 0 to infinity (∞)

Type：

Primary indicator

测量时间点：

两周期采血点

测量方法：

AUC0-∞=AUC0-t+Ct/λz，Ct是最后可测量浓度，λz是消除速率常数。

Measure time point of outcome：

Two-week blood collection points

Measure method：

AUC0-∞ = AUC0-t + Ct/λz, where Ct is the final measurable concentration and λz is the elimination rate constant.

指标中文名：

消除速率常数

指标类型：

次要指标

Outcome：

Decay rate constant

Type：

Secondary indicator

测量时间点：

两周期采血点

测量方法：

使用线性回归方法计算的半对数药时曲线终末段的斜率的相反数

Measure time point of outcome：

Two-week blood collection points

Measure method：

The reciprocal of the slope of the terminal segment of the semi-logarithmic drug-time curve calculated using the linear regression method

指标中文名：

半衰期

指标类型：

次要指标

Outcome：

Half-life

Type：

Secondary indicator

测量时间点：

两周期采血点

测量方法：

按照ln2/λz计算

Measure time point of outcome：

Two-week blood collection points

Measure method：

Calculate according to ln2/λz

指标中文名：

从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

指标类型：

主要指标

Outcome：

The area under the drug concentration-time curve from time 0 to the time t when the last measurable concentration was obtained

Type：

Primary indicator

测量时间点：

两周期采血点

测量方法：

通过线性梯形法则计算。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：

Two-week blood collection points

Measure method：

It is calculated using the linear trapezoidal rule. AUC(i, i+1) = (ti+1 - ti)(Ci + Ci+1) / 2. AUC is the sum of all AUC(i, i+1).

指标中文名：

达峰时间

指标类型：

次要指标

Outcome：

Peak time

Type：

Secondary indicator

测量时间点：

两周期采血点

测量方法：

根据血药浓度-时间实测数据直接获得

Measure time point of outcome：

Two-week blood collection points

Measure method：

It is directly obtained based on the measured data of blood drug concentration over time.

指标中文名：

峰浓度

指标类型：

主要指标

Outcome：

Peak concentration

Type：

Primary indicator

测量时间点：

两周期采血点

测量方法：

根据血药浓度-时间实测数据直接获得

Measure time point of outcome：

Two-week blood collection points

Measure method：

It is directly obtained based on the measured data of blood drug concentration over time.

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

 使用后保存  

说明

Fate of sample：

Preservation 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）：

在研究中每名试验参与者接受受试制剂或参比制剂的顺序将由随机分配表确定。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)：

In the study, the sequence in which each participant receives the test formulation or the reference formulation will be determined by the random allocation table. The random allocation table will be generated by the statistical unit using the block randomization method with SAS (version 9.4 or higher).

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

Blinding：

Open-label

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）：

无

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：

CRF;EDC

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

CRF;EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-04-02 16:16:35
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