ChiCTR2600124804 版本V1.0 版本创建时间2026/05/18 11:30:26 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：

 ChiCTR2600124804 

最近更新日期：

Date of Last Refreshed on：

 2026-05-18 11:29:58 

注册时间：

Date of Registration：

 2026-05-18 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

评估雷贝拉唑钠肠溶片对TQ05105片pH依赖的药代动力学影响的单中心、开放、单剂量、固定序列、自身对照I期临床试验

Public title：

A single-center, open-label, single-dose, fixed-dose regimen, self-controlled Phase I clinical trial to evaluate the effect of rabeprazole sodium enteric-coated tablets on the pH-dependent pharmacokinetics of TQ05105 tablets

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评估雷贝拉唑钠肠溶片对TQ05105片pH依赖的药代动力学影响的单中心、开放、单剂量、固定序列、自身对照I期临床试验

Scientific title：

A single-center, open-label, single-dose, fixed-dose regimen, self-controlled Phase I clinical trial to evaluate the effect of rabeprazole sodium enteric-coated tablets on the pH-dependent pharmacokinetics of TQ05105 tablets

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：

黄洁 

研究负责人：

阳国平; 左笑丛 

Applicant：

Huang Jie 

Study leader：

Yang Guoping; Zuo Xiaocong 

申请注册联系人电话：

Applicant telephone：

 +86 731 8991 8665

研究负责人电话：

Study leader's
telephone：

+86 731 8991 8938

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：

 cellahuang1988@163.com

研究负责人电子邮件：

Study leader's E-mail：

 ygp9880@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：

中国湖南省长沙市岳麓区桐梓坡路138号

研究负责人通讯地址：

中国湖南省长沙市岳麓区桐梓坡路138号

Applicant address：

No. 138 Tongzipo Road, Yuelu District, Changsha City, Hunan Province, China

Study leader's address：

No. 138 Tongzipo Road, Yuelu District, Changsha City, Hunan Province, China

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：

中南大学湘雅三医院临床试验研究中心

Applicant's institution：

Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University

研究负责人所在单位：

中南大学湘雅三医院临床试验研究中心

Affiliation of the Leader：

Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South 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：

 26095

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：

中南大学湘雅三医院伦理委员会

Name of the ethic committee：

Institutional Review Board of The Third Xiangya Hospital of Central South University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-23 00:00:00

伦理委员会联系人：

李瑶

Contact Name of the ethic committee：

Yao Li

伦理委员会联系地址：

中南大学湘雅三医院科教楼

Contact Address of the ethic committee：

Science and Education Building, The Third Xiangya Hospital of Central South University

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 731 8861 8938

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：

中南大学湘雅三医院

Primary sponsor：

Xiangya Third Hospital of Central South University

研究实施负责（组长）单位地址：

湖南省长沙市岳麓区桐梓坡路138号

Primary sponsor's address：

No. 138, Tongzipo Road, Yuelu District, Changsha City, Hunan 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)：

湖南

市(区县)：

Country：

China

Province：

Hunan

City：

单位(医院)：

中南大学湘雅三医院

具体地址：

湖南省长沙市岳麓区桐梓坡路138号

Institution
hospital：

Xiangya Third Hospital of Central South University

Address：

No. 138, Tongzipo Road, Yuelu District, Changsha City, Hunan Province

经费或物资来源：

正大天晴药业集团股份有限公司

Source(s) of funding：

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

研究疾病：

中高危骨髓纤维化、急/慢性抗移植物宿主病、嗜血综合征等  

Target disease：

Intermediate/high-risk myelofibrosis, acute/chronic graft-versus-host disease, hemophagocytic syndrome, etc.

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：

 I期临床试验 

Study phase：

1

研究设计：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

主要研究目的：评价雷贝拉唑对TQ05105片药代动力学的影响。 次要研究目的：评价健康试验参与者单次口服TQ05105片以及与雷贝拉唑联合用药后的安全性和耐受性。  

Objectives of Study：

Primary Objective: To evaluate the effect of rabeprazole on the pharmacokinetics of TQ05105 tablets. Secondary Objective: To evaluate the safety and tolerability of single oral administration of TQ05105 tablets alone and in combination with rabeprazole in healthy study participants.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

试验参与者必须符合下列所有标准才能入选： 1.试验前签署知情同意书、并对试验内容、过程及可能出现的不良反应充分了解；能够按照试验方案要求完成研究； 2.试验参与者（包括伴侣）愿意自筛选至最后一次试验用药品给药后6个月内无妊娠计划、无捐精、捐卵计划，且自愿采取有效避孕措施； 3.年龄18~45周岁（含）以上的健康试验参与者，男女兼有； 男性试验参与者体重不低于50.0公斤、女性试验参与者体重不低于45.0公斤。体重指数（BMI）＝体重（kg）/身高^2（m^2），体重指数在18.0~28.0 kg/m^2范围内（包括临界值）。

Inclusion criteria

The participants in the trial must meet all of the following criteria to be eligible: 1. Sign the informed consent form before the trial, fully understand the trial content, process and possible adverse reactions; and be able to complete the study as per the trial protocol; 2. The trial participants (including their partners) are willing to refrain from pregnancy planning, sperm donation, and egg donation for the next 6 months after the last administration of the trial medication, and voluntarily take effective contraceptive measures; 3. Healthy trial participants aged 18 to 45 years (inclusive) of either gender; Male trial participants have a body weight of no less than 50.0 kilograms, and female trial participants have a body weight of no less than 45.0 kilograms. Body Mass Index (BMI) = weight (kg) / height^2 (m^2), with a BMI within the range of 18.0 to 28.0 kg/m^2 (including the critical value).

排除标准：

符合一条或多条下列标准的试验参与者将被排除： 1.生命体征、体格检查、心电图、临床实验室检查异常有临床意义且研究医生判断不适合参加临床试验者； 2.既往1年内或现患有循环系统、消化系统、呼吸系统、泌尿系统、神经系统、血液系统、内分泌代谢、肿瘤、免疫、精神等严重或慢性疾病者或可能干扰试验结果的任何其他疾病者； 3.筛选时血常规检查中血小板计数、中性粒细胞绝对值低于参考值下限者； 4.患有任何增加出血性风险的疾病，如痔疮、急性胃炎或胃及十二指肠溃疡等； 5)筛选时谷丙转氨酶＞1.2×正常值上限（ULN），或谷草转氨酶＞1.2×ULN，或碱性磷酸酶＞1.2×ULN，或总胆红素＞1.2×ULN，或经研究医生判断异常有临床意义者； 6.筛选前5年内患有任何恶性肿瘤； 7.存在可能影响研究药物吸收、分布、代谢或排泄的状态（如无法吞咽等）或接受过可能影响药物吸收、分布、代谢或排泄的胃肠道切除术者； 8.对雷贝拉唑、TQ05105或其辅料成分过敏者，或过敏体质者（如对两种或两种以上物质过敏，包括药物过敏史、易发生皮疹、湿疹、荨麻疹、哮喘等）； 9.筛选前4周内使用过任何CYP3A4、CYP2C9和CYP2C19酶的强或中诱导剂或抑制剂（详见附录 2）； 10.筛选前4周内使用过任何处方药、非处方药、中草药或食物补充剂（如维生素、钙补充剂等）； 11.筛选前3个月内使用任何抑酸剂治疗； 12.筛选前3个月内或药物的5个半衰期内（以时间较长者为准）参加过任何药物临床试验并使用了任何临床试验药物者； 13.人类免疫缺陷病毒（HIV）抗体、乙肝表面抗原（HBsAg）、丙型肝炎病毒（HCV）抗体或梅毒螺旋体抗体的检查结果为阳性； 14.筛选时肾小球滤过率（GFR）＜90 mL/min/1.73m^2； 15.筛选前3个月内平均每日吸烟大于5支； 16.筛选前3个月内有药物滥用史，或尿液药物筛查阳性者； 17.筛选前3个月内经常饮酒者，即每周饮酒超过14单位酒精（1单位=360 mL啤酒或45 mL酒精量为40%的烈酒或150 mL葡萄酒），或酒精呼气试验阳性者； 18.筛选前4周内献血或失血＞＝200 mL，或进行血浆置换； 19.给药前72 h内进食过任何含有酒精（或酒精呼气试验阳性）、葡萄柚汁/西柚汁或咖啡、茶、可乐、巧克力的食物或饮料者； 20.妊娠期或哺乳期女性试验参与者，或血妊娠结果阳性或超出正常值上限者，或育龄期女性试验参与者筛选前2周内发生非保护性行为； 21.筛选前2周内进行剧烈运动（如马拉松运动员、举重运动员）； 22.研究者认为具有其他任何不宜参加此试验因素者。

Exclusion criteria：

Participants who meet one or more of the following criteria will be excluded: 1. Those with abnormal vital signs, physical examination results, electrocardiogram findings, or clinical laboratory tests that have clinical significance and are judged by the study doctor to be unsuitable for participating in the clinical trial; 2. Those who have had serious or chronic diseases in the past 1 year or currently have diseases in the circulatory system, digestive system, respiratory system, urinary system, nervous system, blood system, endocrine and metabolic system, tumors, immunity, or mental health, or any other diseases that may interfere with the test results; 3. Those whose platelet count and absolute neutrophil value in the blood routine test at the screening stage are lower than the lower limit of the reference value; 4. Those with any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis or gastric and duodenal ulcers, etc.; 5. Those whose alanine aminotransferase (ALT) is > 1.2 × the upper limit of normal (ULN), or aspartate aminotransferase (AST) is > 1.2 × ULN, or alkaline phosphatase is > 1.2 × ULN, or total bilirubin is > 1.2 × ULN, or judged by the study doctor to have clinically significant abnormalities; 6. Those who have had any malignant tumor within the past 5 years; 7. Those with conditions that may affect the absorption, distribution, metabolism or excretion of the study drug (such as inability to swallow, etc.) or those who have undergone gastrointestinal resection surgery that may affect the absorption, distribution, metabolism or excretion of the drug; 8. Those who are allergic to rabeprazole, TQ05105 or its excipient components, or have an allergic constitution (such as having an allergy to two or more substances, including a history of drug allergy, prone to rash, eczema, urticaria, asthma, etc.); 9. Those who have used any strong or moderate inducers or inhibitors of CYP3A4, CYP2C9 and CYP2C19 enzymes within 4 weeks before screening (see Appendix 2); 10. Those who have used any prescription drugs, over-the-counter drugs, herbal medicines or food supplements (such as vitamins, calcium supplements, etc.) within 4 weeks before screening; 11. Those who have received any acid-suppressing treatment within 3 months before screening; 12. Those who have participated in any drug clinical trials within 3 months before screening or during the 5 half-life period of the drug (whichever is longer) and have used any clinical trial drugs; 13. Those with positive results for HIV antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or syphilis spirochete antibody; 14. Those with a glomerular filtration rate (GFR) of < 90 mL/min/1.73m^2 at screening; 15. Those who smoke more than 5 cigarettes per day within the past 3 months; 16. Those who have a history of drug abuse within the past 3 months, or have a positive urine drug screening; 17. Those who frequently drink alcohol, that is, consume more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol liquor or 150 mL of wine), or have a positive alcohol breath test; 18. Those who have donated blood or lost blood >= 200 mL within 4 weeks before screening, or undergone plasma exchange; 19. Those who have consumed any food or beverage containing alcohol (or have a positive alcohol breath test), grapefruit juice/western grape juice or coffee, tea, cola, chocolate within 72 hours before administration; 20. Those who are pregnant or lactating, or have a positive blood pregnancy result or exceed the upper limit of the normal value, or those who have unprotected sexual activity within 2 weeks before screening; 21. Those who have engaged in intense exercise (such as marathon runners, weightlifters) within 2 weeks before screening; 22. Those who, in the researcher's opinion, have any other factors that are not suitable for participating in this trial.

研究实施时间：

Study execute time：

从 From 2026-04-17 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-05-18 00:00:00 至 To 2026-07-01 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 16

Group：

Experimental group

Sample size：

干预措施：

TQ05105片:分别于D1和D8早晨空腹状态下给药1次（D8空腹口服雷贝拉唑钠肠溶片40 mg，间隔1 h后服用TQ05105片15 mg），单次给药剂量15mg，用约240 mL水送服。 雷贝拉唑钠肠溶片：分别于D2和D8早晨空腹状态下给药1次.单次给药剂量40mg，用约240 mL水送服。

干预措施代码：

Intervention：

TQ05105 Tablet: Administer 1 dose in the morning on D1 and D8 (on an empty stomach) (On D8, take 40 mg of Rabeprazole Sodium Enteric-coated Tablets orally on an empty stomach, followed by 15 mg of TQ05105 Tablet 1 hour later). The single dose is 15 mg, and it is taken with approximately 240 mL of water. Rabeprazole Sodium Enteric-coated Tablets: Administer 1 dose in the morning on D2 and D8 (on an empty stomach). The single dose is 40 mg, and it is taken with approximately 240 mL of water.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖南 

市(区县)：

  

Country：

China

Province：

Hunan

City：

单位(医院)：

 中南大学湘雅三医院 

单位级别：

 三甲 

Institution
hospital：

The Third Xiangya Hospital of Central South University

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：

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：

生命体征

指标类型：

次要指标

Outcome：

Vital signs

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

12导联心电图

指标类型：

次要指标

Outcome：

12-lead ECG

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

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：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

达峰时间

指标类型：

次要指标

Outcome：

Tmax

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

半衰期

指标类型：

次要指标

Outcome：

t1/2

Type：

Secondary 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 45 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）：

无

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

None

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：

无

Blinding：

None

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

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）：

文章发表

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

Article published

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：

数据采集：由研究者或其授权的CRC通过独立的账号进入数据管理系统，进行数据采集。 数据管理：数据管理员根据方案设计eCRF，eCRF中包含除外部数据外方案中规定的全部数据点。由EDC系统直接导出eCRF(PDF格式)。

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

Data collection: The researcher or their authorized CRC accesses the data management system through an independent account to conduct data collection. Data management: The data manager designs the eCRF according to the protocol, and the eCRF includes all the data points stipulated in the protocol except for external data. The eCRF (in PDF format) is directly exported by the EDC system.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-05-18 11:29:58