ChiCTR2600115883 版本V1.0 版本创建时间2026/01/01 13:41:01 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：

 ChiCTR2600115883 

最近更新日期：

Date of Last Refreshed on：

 2026-01-01 13:40:38 

注册时间：

Date of Registration：

 2026-01-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

非奈利酮片的生物等效性试验

Public title：

Bioequivalence study of finerenone tablets

注册题目简写：

English Acronym：

研究课题的正式科学名称：

非奈利酮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：

A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence, two-way crossover bioequivalence study of finerenone tablets under fasting and postprandial conditions in healthy Chinese 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 13928808723

研究负责人电话：

Study leader's
telephone：

+86 20 34859951

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, Panyu District, Guangzhou City

Study leader's address：

No. 8, Fuyu East Road, Panyu District, Guangzhou City

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：

Panyu Central Hospital Affiliated to 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：

 2025-036（YW）-02

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：

 2025-11-17 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：

广州市番禺区福愉东路8号

Contact Address of the ethic committee：

No. 8, Fuyu East Road, Panyu District, Guangzhou City

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：

广州市番禺区福愉东路8号

Primary sponsor's address：

No. 8, Fuyu East Road, Panyu District, Guangzhou City

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：

广州市番禺区福愉东路8号

Institution
hospital：

The Affiliated Panyu Central Hospital, Guangzhou Medical University

Address：

No. 8, Fuyu East Road, Panyu District, Guangzhou City

经费或物资来源：

江苏润恒制药有限公司

Source(s) of funding：

Jiangsu Runheng 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：

健康受试者空腹或餐后状态下，单次口服江苏润恒制药有限公司生产的受试制剂非奈利酮片（规格：20mg）或Bayer AG生产的参比制剂非奈利酮片（商品名：Kerendia?；规格：20mg），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。考察受试制剂和参比制剂在健康受试者中的安全性。  

Objectives of Study：

In healthy subjects, under fasting or postprandial conditions, a single oral dose of the test formulation of finerenone tablets (specification: 20mg) produced by Jiangsu Runheng Pharmaceutical Co., Ltd. or the reference formulation of finerenone tablets (trade name: Kerendia?; specification: 20mg) produced by Bayer AG was administered. The pharmacokinetic parameters of the test formulation and the reference formulation in healthy subjects under fasting or postprandial conditions were investigated respectively to evaluate the bioequivalence of the two formulations. The safety of the test formulation and the reference formulation in healthy subjects was also examined.

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.健康男性或女性； 2.年龄≥18周岁（包括临界值）； 3.男性体重≥50kg，女性体重≥45kg，18.5 kg/m2≤体重指数（BMI）≤26.0 kg/m2[BMI=体重（kg）/身高^2（m^2）]； 4.筛选期至研究结束后3个月内采取有效的避孕措施（包括受试者伴侣），并保证此期间的性生活中采用一种或一种以上避孕措施，且无捐精或捐卵计划者； 5.试验前自愿签署知情同意书，并对试验内容、过程及可能出现的不良反应充分了解，同意且有能力按照试验方案的要求参加所有给药和检查；

Inclusion criteria

1. Healthy male or female; 2. Age >=18 years old (including the critical value); 3. Male weight >=50kg, female weight >=45kg, 18.5 kg/m 2 <= body mass index (BMI) <=26.0 kg/m 2 [BMI= weight (kg)/height 2 (m 2)]; 4. During the screening period, effective contraceptive measures (including the partner of the subject) were taken within 3 months after the end of the study, and one or more contraceptive measures were ensured to be used in sexual life during this period, and there were no plans for sperm or egg donation; 5. Before the trial, voluntarily sign the informed consent form, fully understand the content, process and possible adverse reactions of the trial, and agree and have the ability to participate in all drug administration and examinations as required by the trial protocol;

排除标准：

1.既往或目前正患有循环系统、内分泌系统、神经系统、消化系统、呼吸系统、泌尿系统、血液学、免疫学、精神病学及代谢异常等研究者认为临床严重疾病或能干扰试验结果的其他疾病（如：肝功能障碍、肾功能不全、恶性肿瘤、高钾血症、急性肾衰竭、Addison氏病等）者；
2.血清钾>5.0 mmol/L者；
3.既往或目前有慢性或活动性消化道疾病如胃肠道穿孔、胃肠道瘘、食管疾病、胃炎、胃肠道溃疡、肠炎、胃食管反流、胰腺炎、肠易激综合征，活动性胃肠道出血或进行过消化道手术，且研究者认为目前仍有临床意义者；或首次服用研究药物前7天内有消化道症状（腹泻、便秘、恶心、呕吐、排便不规律、或腹泻便秘交替性发作），且研究者认为不宜参加试验者；
4.存在研究者判定为有临床意义的药物、食物或其他物质过敏史，或对非奈利酮过敏者，或对盐皮质激素受体拮抗剂（如依普利酮）过敏者；
5.首次服用研究药物前3个月内接受过手术，或计划在试验期间进行手术者；
6.首次服用研究药物前14天内使用过任何药物（包括处方药、非处方药和中草药）、保健品和功能性维生素者；
7.首次服用研究药物前30天内或末次给药时间距本研究首次服用研究药物不足7个半衰期（以最长者为准）使用过或试验期间计划使用CYP3A4强效抑制剂（如伊曲康唑、酮康唑、利托那韦、奈非那韦、考比司他、克拉霉素、泰利霉素、奈法唑酮）、CYP3A4强效和中效诱导剂（如利福平、卡马西平、苯妥英、苯巴比妥、圣约翰草）以及依非韦伦或其他CYP3A4中效诱导剂、升高血清钾的药物【保钾利尿剂（如阿米洛利、氨苯蝶啶）、其他盐皮质激素受体拮抗剂（MRA，如依普利酮、艾沙利酮、螺内酯、坎利酮等）、补钾剂（如氯化钾、枸橼酸钾等）、含甲氧苄啶或甲氧苄啶/磺胺甲噁唑的抗菌药】、抗高血压药物【血管紧张素转化酶抑制剂（ACEi类，如贝那普利、福辛普利、培哚普利、依那普利、卡托普利）、血管紧张素II受体拮抗剂（ARB类，如氯沙坦、缬沙坦、厄贝沙坦、替米沙坦、坎地沙坦、奥美沙坦）等】；
8.筛选前3个月内入组了任何临床试验并使用过任何临床研究用药或接受过医疗器械干预者；
9.首次服用研究药物前3个月内献血或接受输血或使用血制品者，或失血超过400mL（女性正常生理期失血除外）者，或计划在研究期间或研究结束后1周内献血或血液成份者；
10.血管穿刺条件差，不能忍受静脉穿刺和/或有晕血、晕针史者；
11.女性首次服用研究药物前30天内使用过口服避孕药者，或首次服用研究药物前6个月内使用过长效雌激素或孕激素注射剂或埋植剂者；
12.育龄女性在首次服用研究药物前14天内有过无保护性行为者，或妊娠期或哺乳期女性，或妊娠检测阳性；
13.对饮食有特殊要求，不能遵守统一饮食或吞咽困难者；
14.首次服用研究药物前3个月内每天饮用过量茶、咖啡或含咖啡因的饮料（8杯以上，1杯=250mL）者；
15.遗传性半乳糖不耐受、乳糖酶缺乏症或葡萄糖-半乳糖吸收不良症者；
16.首次服用研究药物前48小时内曾摄入或计划在研究期间摄入任何含咖啡因的食物或饮料（如咖啡、浓茶、巧克力等）、富含黄嘌呤的食物（如沙丁鱼、动物肝脏等）、葡萄柚或相关柑橘类水果（如酸橙、柚子），以及杨桃、木瓜、石榴或以上水果制品者；
17.嗜烟者或首次服用研究药物前3个月内平均每日吸烟量≥5支者，或试验期间不能停止使用任何烟草类产品者；
18.首次服用研究药物前6个月内经常饮酒者（每周饮用>14个单位的酒精：约啤酒（按5%计）360 mL，或烈酒（按40%计）45 mL，或葡萄酒（按12%计）150 mL），或试验期间不愿停止饮酒及酒精饮料者，或试验期间不能禁酒者，或酒精呼气检查结果大于0.0mg/100mL者；
19.首次服用研究药物前6个月内有药物滥用史者或首次服用研究药物前3个月内使用过毒品者或毒品五项筛查（包括：吗啡、冰毒（甲基安非他明）、氯胺酮、摇头丸（二亚甲基双氧安非他明）、大麻（四氢大麻酚酸））任意一项阳性者；
20.生命体征检查、体格检查、实验室检查（血常规、尿干化学+尿沉渣定量、血生化、感染四项、凝血四项等）、12-导联心电图检查等，结果显示异常且经研究医生判断异常有临床意义者；
21.首次服用研究药物前4周内接种过疫苗者或试验期间计划接种疫苗者；
22.因个人原因无法参加本试验或研究者认为不应纳入者；

Exclusion criteria：

1. Have had or are currently suffering from diseases that researchers consider clinically serious, such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, urinary system, hematology, immunology, psychiatry, and metabolic disorders, or other diseases that can interfere with the test results (e.g. Those with liver dysfunction, renal insufficiency, malignant tumors, hyperkalemia, acute renal failure, Addison's disease, etc. 2. Those with serum potassium >5.0 mmol/L; 3. Those who have a history or are currently suffering from chronic or active digestive tract diseases such as gastrointestinal perforation, gastrointestinal fistula, esophageal diseases, gastritis, gastrointestinal ulcers, enteritis, gastroesophageal reflux, pancreatitis, irritable bowel syndrome, active gastrointestinal bleeding or have undergone digestive tract surgery, and whom researchers believe still have clinical significance at present; Or those who have experienced digestive tract symptoms (diarrhea, constipation, nausea, vomiting, irregular defecation, or alternating episodes of diarrhea and constipation) within 7 days before the first use of the study drug, and whom the researcher deems unsuitable to participate in the trial; 4. Those who have a history of allergies to drugs, foods or other substances that researchers have determined to be of clinical significance, or are allergic to fineridone, or are allergic to mineralocorticoid receptor antagonists (such as epleridone); 5. Those who have undergone surgery within three months prior to the first use of the study drug, or plan to undergo surgery during the trial period; 6. Those who have used any drugs (including prescription drugs, over-the-counter drugs and Chinese herbal medicines), health supplements and functional vitamins within 14 days prior to the first use of the study drug; 7. Strong CYP3A4 inhibitors (such as itraconazole, ketoconazole, ritonavir, nefinavir, cobisumab, clarithromycin, terithromycin, nefazolidone) have been used or are planned to be used during the trial period within 30 days before the first administration of the study drug or less than 7 half-lives from the first administration of the study drug in this study (whichever is the longest) And medium-potency inducers (such as rifampicin, carbamazepine, phenytoin, phenobarbital, St. John's wort), as well as efaviren or other medium-potency CYP3A4 inducers, drugs that increase serum potassium [potassium-sparing diuretics (such as amiloride, triamterene), other mineralocorticoid receptor antagonists (MRA), Such as epirazone, isalidone, spironolactone, canlidone, etc., potassium supplements (such as potassium chloride, potassium citrate, etc.), antibacterial drugs containing trimethoprim or trimethoprim/sulfamethoxazole, antihypertensive drugs [angiotensin-converting enzyme inhibitors (ACEi class) Such as benazepril, fosinopril, perindopril, enalapril, captopril), angiotensin II receptor antagonists (ARB class, such as losartan, valsartan, irbesartan, telmisartan, Candesartan, olmesartan), etc. 8. Those who have been enrolled in any clinical trial within the three months prior to screening and have used any clinical research drugs or received medical device intervention; 9. Those who have donated blood, received a blood transfusion or used blood products within three months before taking the study drug for the first time, or have lost more than 400mL of blood (excluding blood loss during normal menstrual periods for women), or plan to donate blood or blood components during the study period or within one week after the study ends; 10. Those with poor conditions for vascular puncture, who cannot tolerate venipuncture and/or have a history of fainting with blood or needles; 11. Women who have taken oral contraceptives within 30 days before their first use of the study drug, or who have taken long-acting estrogen or progesterone injections or implants within 6 months before their first use of the study drug; 12. Women of childbearing age who have had unprotected sex within 14 days prior to the first use of the study drug, or pregnant or lactating women, or those with a positive pregnancy test; 13. Those who have special dietary requirements, cannot follow the unified diet or have difficulty swallowing; 14. Those who consumed excessive amounts of tea, coffee or caffeinated beverages (more than 8 cups, 1 cup =250mL) daily for three months prior to the first use of the study drug; 15. People with hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption; 16. Those who have consumed or plan to consume any food or beverage containing caffeine (such as coffee, strong tea, chocolate, etc.), food rich in xanthine (such as sardines, animal liver, etc.), grapefruit or related citrus fruits (such as lime, pomelo), as well as star fruit, papaya, pomegranate or the above fruit products within 48 hours before the first use of the study drug during the study period; 17. Smokers or those who smoked an average of 5 cigarettes per day within the first 3 months prior to taking the study drug, or those who were unable to stop using any tobacco products during the trial period; 18. Regular drinkers (consuming more than 14 units of alcohol per week) within 6 months prior to the first use of the study drug: Approximately 360 mL of beer (calculated at 5%), or 45 mL of spirits (calculated at 40%), or 150 mL of wine (calculated at 12%), or those who are unwilling to stop drinking alcohol and alcoholic beverages during the trial period, or those who cannot abstaining from alcohol during the trial period, or those whose breath test result for alcohol is greater than 0.0mg/100mL; 19. Those who have a history of drug abuse within 6 months before the first use of the study drug, or who have used drugs within 3 months before the first use of the study drug, or who test positive for any one of the five drug screenings (including: morphine, methamphetamine, ketamine, ecstasy (dimethylene dioxyethanol), or cannabis (tetrahydrocannabinol)); 20. Vital sign examination, physical examination, laboratory tests (blood routine, urine dry chemistry + urine sediment quantification, blood biochemistry, four items of infection, four items of coagulation, etc.), 12-lead electrocardiogram examination, etc., if the results show abnormalities and the doctor determines that the abnormalities have clinical significance; 21. Those who have been vaccinated within 4 weeks before the first use of the study drug or those who plan to be vaccinated during the trial period; 22. Those who are unable to participate in this trial due to personal reasons or who the researcher deems should not be included;

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2026-01-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-01-04 00:00:00 至 To 2026-01-10 00:00:00

干预措施：

Interventions：

组别：

空腹试验：T-R组

样本量：

 18

Group：

Fasting test: T-R group

Sample size：

干预措施：

空腹口服受试制剂(T)20mg(1片)，整片吞服，约240mL温水送服。3天后交叉给药。

干预措施代码：

Intervention：

Take the test preparation (T) orally on an empty stomach, swallowing the entire tablet of 20mg (1 tablet) and consuming it with approximately 240mL of warm water. After 3 days, proceed with the crossover administration.

Intervention code：

组别：

空腹试验：R-T组

样本量：

 18

Group：

Fasting test: R-T group

Sample size：

干预措施：

空腹口服参比制剂(R)20mg(1片)，整片吞服，约240mL温水送服。3天后交叉给药。

干预措施代码：

Intervention：

Take the reference preparation (R) orally on an empty stomach, swallowing the entire tablet and consuming it with approximately 240mL of warm water. After 3 days, proceed with the crossover administration.

Intervention code：

组别：

餐后试验：T-R组

样本量：

 18

Group：

Postprandial test: T-R group

Sample size：

干预措施：

高脂餐后30+/-0.5min内开始口服受试制剂(T)20mg(1片)，整片吞服，约240mL温水送服。3天后交叉给药。

干预措施代码：

Intervention：

Orally administer 20mg (1 tablet) of the test formulation (T) within 30 minutes +/- 0.5 minutes after a high-fat meal, swallowing the entire tablet and consuming it with approximately 240mL of warm water. After 3 days, proceed with the crossover administration.

Intervention code：

组别：

餐后试验：R-T组

样本量：

 18

Group：

Postprandial test: R-T group

Sample size：

干预措施：

高脂餐后30+/-0.5min内开始口服参比制剂(R)20mg(1片)，整片吞服，约240mL温水送服。3天后交叉给药。

干预措施代码：

Intervention：

Take orally 20mg (1 tablet) of the reference preparation (R) within 30 minutes +/- 0.5 minutes after a high-fat meal, swallowing the entire tablet and consuming it with approximately 240mL of warm water. After 3 days, proceed with the crossover administration.

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：

从给药到可检测最低血药浓度的时间内曲线下面积

指标类型：

主要指标

Outcome：

AUC0-t

Type：

Primary indicator

测量时间点：

两个试验周期共36个采血点

测量方法：

通过线性梯形法则计算

Measure time point of outcome：

There were a total of 36 blood collection points in the two test cycles

Measure method：

Calculated by the linear trapezoidal rule

指标中文名：

末端相的血药浓度消除速率常数

指标类型：

次要指标

Outcome：

λz

Type：

Secondary indicator

测量时间点：

两个试验周期共36个采血点

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：

There were a total of 36 blood collection points in the two test cycles

Measure method：

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

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：

两个试验周期共36个采血点

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：

There were a total of 36 blood collection points in the two test cycles

Measure method：

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

指标中文名：

达峰浓度的时间

指标类型：

次要指标

Outcome：

Tmax

Type：

Secondary indicator

测量时间点：

两个试验周期共36个采血点

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：

There were a total of 36 blood collection points in the two test cycles

Measure method：

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

指标中文名：

消除终末端半衰期

指标类型：

次要指标

Outcome：

t1/2

Type：

Secondary indicator

测量时间点：

两个试验周期共36个采血点

测量方法：

按照ln2/λz计算

Measure time point of outcome：

There were a total of 36 blood collection points in the two test cycles

Measure method：

Calculate according to ln2/λz

指标中文名：

从给药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：

两个试验周期共36个采血点

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：

There were a total of 36 blood collection points in the two test cycles

Measure method：

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

指标中文名：

残留面积百分比

指标类型：

次要指标

Outcome：

AUC_%Extrap

Type：

Secondary indicator

测量时间点：

两个试验周期共36个采血点

测量方法：

以[(AUC0-∞-AUC0-t)/AUC0-∞]×100%计算

Measure time point of outcome：

There were a total of 36 blood collection points in the two test cycles

Measure method：

Calculate with [(AUC0-∞-AUC0-t)/AUC0-∞]×100%

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 60 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 order in which each subject receives the test preparation or the reference preparation will be determined by a random allocation table. The statistical unit shall generate the random allocation table by 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 study

是否共享原始数据：

IPD sharing

是Yes

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）：

国家生物信息中心

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

China Nation center for Bioinformation

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：

电子采集和管理系统和病历报告表

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

EDC and CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-01-01 13:40:38