ChiCTR2500097758 版本V1.0 版本创建时间2025/02/25 14:58:00 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：

ChiCTR2500097758 

最近更新日期：

Date of Last Refreshed on：

2025-02-25 14:57:53 

注册时间：

Date of Registration：

2025-02-25 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

富马酸丙酚替诺福韦在中国健康受试者中进行的单中心、随机、开放、单次口服给药、两制剂、三序列、三周期（空腹）/两序列、四周期（餐后）的人体生物等效性试验

Public title：

A single-center, randomized, open, single-dose, two-agent, three-sequence, three-cycle (fasting)/two-sequence, four-cycle (fed) a bioequivalence trial of Tenofovir Alafenamide Fumarate Tablets in healthy Chinese volunteers

注册题目简写：

English Acronym：

研究课题的正式科学名称：

富马酸丙酚替诺福韦片在中国健康受试者中进行的单中心、随机、开放、单次口服给药、两制剂、三序列、三周期（空腹）/两序列、四周期（餐后）的人体生物等效性试验

Scientific title：

A single-center, randomized, open, single-dose, two-agent, three-sequence, three-cycle (fasting)/two-sequence, four-cycle (fed) a bioequivalence trial of Tenofovir Alafenamide Fumarate Tablets in healthy Chinese volunteers

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：

黄春琦 

研究负责人：

王莹 

Applicant：

ChunqiHuang 

Study leader：

YingWang 

申请注册联系人电话：

Applicant telephone：

+86 159 9008 4041

研究负责人电话：

Study leader's telephone：

+86 183 6712 4548

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：

1961288926@qq.com

研究负责人电子邮件：

Study leader's E-mail：

nancywangying@163.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：

浙江省杭州市拱墅区潮王路318号

研究负责人通讯地址：

浙江省杭州市拱墅区环城东路208号

Applicant address：

No. 318, Chaowang Road, Gongshu District, Hangzhou City, Zhejiang Province

Study leader's address：

No. 208, Huancheng East Road, Gongshu District, Hangzhou City, Zhejiang 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：

浙江中医药大学附属第二医院

Applicant's institution：

The Second Affiliated Hospital of Zhejiang Chinese Medical University

研究负责人所在单位：

杭州市红十字会医院

Affiliation of the Leader：

Hangzhou Red Cross 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：

2022-011-001; 2022-011-002; 2022-011-003

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：

杭州市红十字会医院医学伦理审查委员会

Name of the ethic committee：

Hangzhou Red Cross Hospital Medical Ethics Review Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2022-12-20 00:00:00

伦理委员会联系人：

王宇

Contact Name of the ethic committee：

Yu Wang

伦理委员会联系地址：

浙江省杭州市拱墅区环城东路208号

Contact Address of the ethic committee：

208 Huancheng East Road, Gongshu District, Hangzhou, Zhejiang, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 137 5813 7404

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：

杭州市红十字会医院

Primary sponsor：

Hangzhou Red Cross Hospital

研究实施负责（组长）单位地址：

浙江省杭州市拱墅区环城东路208号

Primary sponsor's address：

208 Huancheng East Road, Gongshu District, Hangzhou, Zhejiang, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

河北

市(区县)：

石家庄

Country：

China

Province：

Hebei

City：

Shijiazhuang

单位(医院)：

河北山姆士药业有限公司

具体地址：

河北省石家庄市桥西区中华南大街与槐安路交叉口成功商务大厦

Institution
hospital：

Hebei Sams Pharmaceutical Co., Ltd

Address：

Chenggong Business Building, intersection of Zhonghua South Street and Huai'an Road, Qiaoxi District, Shijiazhuang City, Hebei Province

经费或物资来源：

河北山姆士药业有限公司

Source(s) of funding：

Hebei Sams Pharmaceutical Co., Ltd

Target disease：

Chronic hepatitis B

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

随机交叉对照 

Study design：

Cross-over 

研究目的：

观察中国健康受试者在空腹状态下单次口服受试制剂富马酸丙酚替诺福韦片（规格：25mg（按C21H29N6O5P计）；生产企业：河北山姆士药业有限公司）和参比制剂富马酸丙酚替诺福韦片（商品名：VEMLIDY?；规格：25mg（以丙酚替诺福韦计）；持证商：Gilead Sciences International Ltd.）后的药代动力学特征，评价空腹状态下两种制剂的生物等效性。  

Objectives of Study：

To observe the pharmacokinetics characteristics of tenofovir alafenamide fumarate tablets between two formulations (Test preparation: 25mg, C21H29N6O5P, Manufacturer: Hebei Samshi Pharmaceutical Co., LTD.; Reference preparation: 25mg, VEMLIDY?, Licensed by Gilead Sciences International Ltd.) in Chinese health volunteers, to evaluate the bioequivalence of the two formulations in fasting after single orally.

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)健康受试者，男女兼有，18～65周岁（含边界值）； (2)男性体重>=50kg，女性体重>=45kg，体重指数为19.0～26.0 kg/m^2（含边界值，计算公式=体重/身高^2）； (3)受试者于试验前签署知情同意书，自愿参加该试验。

Inclusion criteria

(1) Healthy subjects, both male and female, 18~65 years old (including boundary value); (2) Male weight >=50kg, female weight >=45kg, body mass index of 19.0~26.0 kg/m^2 (including boundary value, calculation formula = weight/height^2); (3) The subjects signed the informed consent form before the trial and voluntarily participated in the trial.

排除标准：

1) 具有经研究者判定有临床意义的（包括但不限于）心、肝、肾、胃肠道、胆、内分泌、心血管、神经、精神、呼吸、免疫、血液、造血等系统疾病者；以及具有上述脏器或系统严重疾病史，可能危害受试者安全或影响研究结果者； 2) 生命体征、体格检查、实验室检查（血常规、尿常规、血生化）、心电图、胸片检查显示异常且经研究者判定有临床意义者； 3) 有半乳糖不耐受、乳糖酶缺乏症或葡萄糖-半乳糖吸收不良的罕见遗传问题者； 4) 乙肝表面抗原、乙肝表面抗体、乙肝e抗原、乙肝e抗体、乙肝核心抗体、丙肝抗体（IgM+IgG）、艾滋病抗原及抗体、梅毒特异性抗体检测至少一项异常有临床意义者； 5) 存在研究者判定为有临床意义的食物、药物过敏或其他变态反应性疾病史（哮喘、荨麻疹、湿疹性皮炎等），或既往对富马酸丙酚替诺福韦片及其辅料（α乳糖、微晶纤维素、交联羧甲基纤维素钠、硬脂酸镁、聚乙烯醇、二氧化钛、聚乙二醇、滑石粉和氧化铁黄）过敏者； 6) 不能遵守统一饮食规定（如对标准餐食物不耐受）者； 7) 吞咽困难者； 8) 不能耐受静脉穿刺或静脉采血困难者，或有晕针晕血史者； 9) 筛选前4周内使用过任何与试验药物有相互作用或改变肝酶活性的药物，如抗惊厥药（卡马西平、苯巴比妥、苯妥英钠）、抗分支杆菌药（利福布汀、利福平和利福喷丁）、抗真菌药（伊曲康唑、酮康唑）和圣约翰草等；或筛选前7天内使用过任何处方药、非处方药、中药及保健品者; 10) 筛选前48h内食用过含有咖啡因的食物或饮料（如咖啡、浓茶、可乐、巧克力等）或食用过火龙果、芒果、葡萄柚（西柚）等芸香科果实及其制成的饮料，或食用过含酒精的食物或饮料或有剧烈运动（足球、篮球、跑步、健身操、游泳同等强度运动超过30分钟），或具有其他影响药物吸收、分布、代谢、排泄等因素者； 11) 有嗜烟习惯（筛选前3个月平均每日吸烟量多于5支者）或饮酒习惯（筛选前3个月平均每周饮酒超过28单位酒精，1单位=285mL啤酒或25mL酒精量为40%的烈酒或75mL葡萄酒）者；或试验期间不能停止使用任何烟草类产品者；或试验期间不能禁酒者； 12) 既往有吸毒史、药物滥用史； 13) 筛选前3个月内献血或大量出血（出血量≥400mL）或试验期间有献血计划者； 14) 妊娠或哺乳期女性； 15) 筛选前2周内发生过无保护性行为者（育龄期女性）； 16) 筛选期至研究结束后6个月内有生育计划，不愿采取有效的物理避孕措施（如避孕套、子宫内节育器、避孕环、结扎、禁欲等；安全期避孕法不包含在内）进行避孕（包括受试者伴侣）者，或计划捐精、捐卵者； 17) 筛选前2周内接种过疫苗或在试验期间有疫苗接种计划者； 18) 筛选前3个月内入组其他临床试验并服用相应的试验药物，或正在参加其他临床试验者； 19) 研究者认为依从性差，或具有任何不宜参加此试验因素的受试者。

Exclusion criteria：

1) Those with clinically significant (including but not limited to) heart, liver, kidney, gastrointestinal, gallbladder, endocrine, cardiovascular, neurological, psychiatric, respiratory, immune, blood, hematopoietic and other systemic diseases judged by the investigator; and those who have a history of serious diseases of the above organs or systems, which may endanger the safety of subjects or affect the results of the study; 2) Those who have abnormal vital signs, physical examination, laboratory tests (blood routine, urine routine, blood biochemistry), electrocardiogram, and chest X-ray examination and are judged to be clinically significant by the investigator; 3) Patients with rare genetic problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption; 4) Patients with at least one abnormal test of hepatitis B surface antigen, hepatitis B surface antibody, hepatitis B e antigen, hepatitis B e antibody, hepatitis B core antibody, hepatitis C antibody (IgM + IgG), AIDS antigen and antibody, and syphilis-specific antibody at least one abnormality with clinical significance; 5) Those who have a history of food or drug allergy or other allergic diseases (asthma, urticaria, eczematoid dermatitis, etc.) judged by the investigator to be clinically significant, or those who have been allergic to tenofovir alafenol fumarate tablets and their excipients (α lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talcum powder and iron oxide yellow); 6) Those who are unable to comply with the uniform dietary regulations (such as intolerance to standard meals); 7) Dysphagia; 8) Those who cannot tolerate venipuncture or have difficulty in venous blood collection, or have a history of fainting needle and blood sickness; 9) Use of any drugs that interact with the trial drug or change the activity of liver enzymes within 4 weeks before screening, such as anticonvulsants (carbamazepine, phenobarbital, phenytoin), antimycobacterial drugs (rifabutin, rifampicin and rifapentine), antifungal drugs (itraconazole, ketoconazole) and St. John's wort, etc.; or those who have used any prescription drugs, over-the-counter drugs, Chinese medicines and health products within 7 days before screening; 10) Those who have consumed caffeine food or beverages (such as coffee, strong tea, cola, chocolate, etc.) or consumed dragon fruit, mango, grapefruit (grapefruit) and other rutaceae fruits and beverages made from them within 48 hours before screening, or have consumed alcoholic food or beverages or have strenuous exercise (football, basketball, running, aerobics, swimming at the same intensity for more than 30 minutes), or have other factors that affect drug absorption, distribution, metabolism, excretion, etc.; 11) Those who have a habit of smoking (an average daily smoking of more than 5 cigarettes in the 3 months before screening) or drinking habits (an average of more than 28 units of alcohol per week in the 3 months before screening, 1 unit = 285mL of beer or 25mL of spirits with 40% alcohol or 75mL of wine); or those who cannot stop using any tobacco products during the trial; or those who cannot abstain from alcohol during the test; 12) History of drug abuse or drug abuse; 13) Those who have donated blood or had heavy bleeding (blood loss ≥ 400mL) within 3 months before screening or have a blood donation plan during the trial; 14) Pregnant or lactating females; 15) Those who have had unprotected sex within 2 weeks before screening (females of childbearing age); 16) Have a birth plan within 6 months from the screening period to the end of the study, and are unwilling to take effective physical contraceptive measures (such as condoms, intrauterine devices, contraceptive rings, sterilization, abstinence, etc.); Contraceptive method during the safe period is not included) Those who are using contraception (including the subject's partner), or those who plan to donate sperm or eggs; 17) Those who have been vaccinated within 2 weeks before screening or have a vaccination plan during the trial; 18) Those who have enrolled in other clinical trials and taken the corresponding experimental drugs within 3 months before screening, or are participating in other clinical trials; 19) Subjects with poor compliance in the opinion of the investigator, or with any factors that are not suitable for participating in this trial.

研究实施时间：

Study execute time：

从 From 2023-02-24 00:00:00至 To 2023-07-11 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-02-27 00:00:00 至 To 2023-05-22 00:00:00  

干预措施：

Interventions：

组别：

空腹1组（T-R-R）

样本量：

12

Group：

Fasting 1 Group (T-R-R)

Sample size：

干预措施：

受试者禁食过夜至少10h后单次给药，T-R-R组受试者第一周期空腹单次给药口服受试制剂（T）25mg，第二周期空腹单次口服参比制剂（R）25mg，第三周期空腹单次口服参比制剂（R）25mg。洗脱期设为14天(半衰期大于7次)。

干预措施代码：

Intervention：

subjects in the T-R-R group received 25mg TAF of the test formulation in a fasting single dose in the first cycle, 25mg TAF of the reference formulation in a fasting single dose in the second cycle, 25mg TAF of the reference formulation in a fasting single dose in the third cycle. The washout period was set as 14 days (The half-life is more than 7 times)

Intervention code：

组别：

空腹2 组 （R-T-R）

样本量：

12

Group：

Fasting 2 Group (R-T-R)

Sample size：

干预措施：

受试者禁食过夜至少10h后单次给药，R-T-R组受试者第一周期空腹单次给药口服参比制剂（R）25mg，第二周期空腹单次口服受试制剂（T）25mg，第三周期空腹单次口服参比制剂（R）25mg。洗脱期设为14天(半衰期大于7次)。

干预措施代码：

Intervention：

subjects in the R-T-R group received 25mg TAF of the reference formulation in a fasting single dose in the first cycle, 25mg TAF of the test formulation in a fasting single dose in the second cycle, 25mg TAF of the reference formulation in a fasting single dose in the third cycle. The washout period was set as 14 days (The half-life is more than 7 times)

Intervention code：

组别：

空腹3 组（R-R-T）

样本量：

12

Group：

Fasting 3 Group (R-R-T)

Sample size：

干预措施：

受试者禁食过夜至少10h后单次给药，R-R-T组受试者第一周期空腹单次给药口服参比制剂（R）25mg，第二周期空腹单次口服参比制剂（R）25mg，第三周期空腹单次口服受试制剂（T）25mg。洗脱期设为14天(半衰期大于7次)。

干预措施代码：

Intervention：

subjects in the R-R-T group received 25mg TAF of the reference formulation in a fasting single dose in the first cycle, 25mg TAF of the reference formulation in a fasting single dose in the second cycle, 25mg TAF of the test formulation in a fasting single dose in the third cycle. The washout period was set as 14 days (The half-life is more than 7 times)

Intervention code：

组别：

餐后1组（T-R-T-R）

样本量：

18

Group：

Fed 1 Group (T-R-T-R)

Sample size：

干预措施：

受试者于试验前至少空腹（禁食不禁水）10h，给药当天于服药前 1h 至服药后 1h 内禁止饮水，服药后 4h 内禁食。受试者在给药前 30min 进食高脂高热试验标准餐（食物热量约 800~1000 千卡，其中蛋白质约提供 150 千卡热量，碳水化合物约提供 250 千卡热量，脂肪约提供 500~600 千卡热量），并在 30min 内完成进食（必须进食完高脂餐的全部食物），开始进食试验高脂餐30min 后，T-R-T-R组受试者第一周期单次口服受试制剂（T）25mg，第二周期单次口服参比制剂（R）25mg，第三周期单次口服受试制剂（T）25mg，第四周期单次口服参比制剂（R）25mg。洗脱期设为14天（半衰期大于7次）。

干预措施代码：

Intervention：

The subjects were fasting (fasting without water) for at least 10h before the test, were forbidden to drink water from 1h before to 1h after the drug on the day of administration, and fasted for 4h after the drug. The subjects ate the high-fat high-heat test standard meal (food calories about 800~1000 kcal, protein about 150 kcal, carbohydrate about 250 kcal, fat about 500~600 kcal) 30min before administration.The subjects in the T-R-T-R group were given 25mg of test preparation (T) once in the first cycle, 25mg of reference preparation (R) once in the second cycle, and 25mg of test preparation (T) once in the third cycle. The fourth cycle was a single oral reference preparation (R) of 25mg. The washout period is 14 days (half-life greater than 7 times).

Intervention code：

组别：

餐后2组（R-T-R-T）

样本量：

18

Group：

Fed 2 Group (R-T-R-T)

Sample size：

干预措施：

受试者于试验前至少空腹（禁食不禁水）10h，给药当天于服药前 1h 至服药后 1h 内禁止饮水，服药后 4h 内禁食。受试者在给药前 30min 进食高脂高热试验标准餐（食物热量约 800~1000 千卡，其中蛋白质约提供 150 千卡热量，碳水化合物约提供 250 千卡热量，脂肪约提供 500~600 千卡热量），并在 30min 内完成进食（必须进食完高脂餐的全部食物），开始进食试验高脂餐30min 后，R-T-R-T组受试者第一周期单次口服参比制剂（R）25mg，第二周期单次口服受试制剂（T）25mg，第三周期单次口服参比制剂（R）25mg，第四周期单次口服受试制剂（T）25mg。洗脱期设为14天（半衰期大于7次）。

干预措施代码：

Intervention：

The subjects were fasting (fasting without water) for at least 10h before the test, were forbidden to drink water from 1h before to 1h after the drug on the day of administration, and fasted for 4h after the drug.The subjects ate the high-fat high-heat test standard meal (food calories about 800~1000 kcal, protein about 150 kcal, carbohydrate about 250 kcal, fat about 500~600 kcal) 30min before administration. The subjects in the R-T-R-T group were given a single oral reference preparation (R) of 25mg in the first cycle, a single oral test preparation (T) of 25mg in the second cycle, and a single oral reference preparation (R) of 25mg in the third cycle. In the fourth cycle, test preparation (T) was taken orally once, 25mg. The washout period is 14 days (half-life greater than 7 times).

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江 

市(区县)：

 杭州 

Country：

China 

Province：

Zhejiang  

City：

Hangzhou 

单位(医院)：

杭州市红十字会医院 

单位级别：

三甲 

Institution
hospital：

Hangzhou Red Cross Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

富马酸替诺福韦艾拉酚胺 （TAF） 的峰浓度 （Cmax）

指标类型：

主要指标

Outcome：

Peak concentrations of tenofovir alafenamide fumarate (TAF) (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：

Area under the curve for the time from administration to the lowest detectable blood concentration(AUC0-t)

Type：

Primary indicator

测量时间点：

测量方法：

通过线性梯形法则计算

Measure time point of outcome：

Measure method：

It is calculated by the linear trapezoidal rule

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：

Area under the curve for the time from drug administration to extrapolation to infinity(AUC0-∞)

Type：

Primary indicator

测量时间点：

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：

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：

达峰浓度的时间

指标类型：

次要指标

Outcome：

Time to peak concentration(Tmax)

Type：

Secondary indicator

测量时间点：

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：

Measure method：

The measured data were obtained directly according to the blood concentration and time

指标中文名：

消除速率常数

指标类型：

次要指标

Outcome：

Elimination rate constant(λz)

Type：

Secondary indicator

测量时间点：

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，结果取斜率的相反数

Measure time point of outcome：

Measure method：

The slope of the end segment of the semilogarithmic curve was calculated using the linear regression method, and the result was taken as the inverse of the slope

指标中文名：

消除终末端半衰期

指标类型：

次要指标

Outcome：

Terminal terminal half-life was eliminated(t1/2z)

Type：

Secondary indicator

测量时间点：

测量方法：

按照ln2/λz计算

Measure time point of outcome：

Measure method：

It is calculated as ln2/λz

指标中文名：

残留面积百分比

指标类型：

次要指标

Outcome：

Residual area percentage(AUC_%Extrap)

Type：

Secondary indicator

测量时间点：

测量方法：

以[（AUC0-∞-AUC0-t）/AUC0-∞]×100%计算

Measure time point of outcome：

Measure method：

It was calculated as [(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：

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）：

研究者将判断受试者的入选资格，合格受试者按照筛选号由小到大顺序分配随机号。试验第-1天进行随机，合格受试者按照筛选号从小到大的顺序获得随机号，并根据随机表随机分配进入不同给药序列（T-R-R组/R-T-R组/R-R-T组）。随机表由统计单位南京英锋医药科技有限公司采用SAS 9.4版本软件，按1:1区组随机化方法生成，种子数为20230625，区组长度为10，区组数为5。空腹试验实际入组36例受试者，随机化编号为K001~K036；

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

Eligibility was determined by the investigator, and eligible participants were assigned a random number in descending order of screening number. Randomization was performed on day -1 of the trial. Eligible subjects were randomly assigned to different dosing sequences (T-R-R group / R-T-R group/R-R-T group) according to the random table. The randomization table was generated by the statistical unit Nanjing Yingfeng Medical Technology Co., Ltd. using SAS version 9.4 software according to the 1:1 block randomization method, the seed number was 20230625, the block length was 10, and the block number was 5. A total of 36 subjects were enrolled in the fasting trial, and the randomization number was K001-K036.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

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，分析测试人员将采用盲态分析，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 study. Except for the biological sample analysis and testing personnel, other personnel such as clinical investigators, project management personnel, project monitoring personnel, data management and statistical analysis personnel are not blinded.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

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）：

太美 eCollect EDC V5，https://www.trialos.com.cn/login/

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

TaiMei eCollect EDC V5,https://www.trialos.com.cn/login/

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：

太美 eCollect EDC V5，https://www.trialos.com.cn/login/

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

TaiMei eCollect EDC V5,https://www.trialos.com.cn/login/

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-02-25 14:57:53