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：	ChiCTR2500109725
最近更新日期： Date of Last Refreshed on：	2025-09-24 11:34:01
注册时间： Date of Registration：	2025-09-24 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	巴瑞替尼片生物等效性试验
Public title：	Bioequivalence test of baritinib tablets
注册题目简写：
English Acronym：
研究课题的正式科学名称：	巴瑞替尼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：	Baritinib tablets in Chinese healthy subjects are single-center, randomized, open, and single Dose, two preparations, two cycles, two sequences, double crossing, fasting/postprandial Bioequivalence test under state
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 34859951	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, Qiaonan Street, Panyu District, Guangzhou	Study leader's address：	No. 8 Fuyu East Road, Qiaonan Street, Panyu District, Guangzhou
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：	PYZXYYEC【2024-033（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：	2024-11-06 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：	广州市番禺区桥南街福愉东路8号
Contact Address of the ethic committee：	No. 8 Fuyu East Road, Qiaonan Street, Panyu District, Guangzhou
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：

广州市番禺区桥南街福愉东路8号

Primary sponsor's address：

No. 8 Fuyu East Road, Qiaonan Street, Panyu District, Guangzhou

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, Qiaonan Street, Panyu District, Guangzhou

经费或物资来源：

广州汇智成功药物研究有限公司

Source(s) of funding：

Guangzhou Huizhi Success Drug Research Co., LTD

研究疾病：

类风湿关节炎

Target disease：

Rheumatoid arthritis

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/餐后状态下，单次口服广州绿十字制药股份有限公司生产的受试制剂巴瑞替尼片（规格：4mg/片）或以Eli Lilly Nederland B.V.持有的参比制剂巴瑞替尼片（商品名：OLUMIANT®；规格：4mg/片），比较空腹/餐后状态下受试制剂与参比制剂在健康受试者体内的生物等效性。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：

1.Healthy subjects were given a single oral dose of Baritinib tablets (specification: 4mg/ tablet) produced by Guangzhou Green Cross Pharmaceutical Co., LTD., or Eli Lilly Nederland B.V., during fasting/postmeal conditions. Reference preparation Bariatinib tablets (Trade name: OLUMIANT®; Specification: 4mg/ tablet) to compare the bioequivalence of the test preparation and the reference preparation in healthy subjects under fasting/postprandial conditions. 2.To investigate the safety of test preparations and reference preparations in healthy subjects.

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

1. Fully understand the purpose, nature, method and possible adverse reactions of the test, volunteer as a subject, and  Prior to the commencement of any study procedure, I shall sign an informed consent and guarantee to be taken by me throughout the study  And test;
2. Male and female aged 18-45 years (including 18 and 45 years), with an appropriate sex ratio;
3. Male weight >=50.0kg, female weight >=45.0kg; Body mass index (BMI) was in the range of 19.0 to 26.0kg/m^2  (including critical values);
4. Vital signs examination, physical examination, clinical laboratory examination (blood routine, urine dry chemistry + urine sediment quantification, blood  Biochemistry, Blood transfusion, blood coagulation function, blood pregnancy test (female), alcohol breath test, drug abuse  Screening, COVID-19 screening, chest position, 12-lead electrocardiogram results showed no abnormality or abnormal clinical significance  The Righteous One;
5. Have no pregnancy plan during the screening period and the next 3 months and voluntarily take effective contraception (Appendix 2) and do not donate  Sperm and egg donation program;
6. Be able to communicate well with researchers and understand and comply with the requirements of the study.

排除标准：

1) 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；
2) 有吞咽困难或任何影响药物吸收的胃肠道疾病史者；
3) 存在任何血液循环系统、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任何慢性或严重疾病史，或可能干扰试验结果的任何其他疾病，或既往或现有结核病史者，或3个月内的手术史；
4) 筛选前3个月内患有带状疱疹者；
5) 存在深静脉血栓风险或肺栓塞风险因素者，如高龄、肥胖、有深静脉血栓或肺栓塞病史者，或VTE高危评分（基于Caprini模型）> 2 分者；
6) 血管穿刺条件差，或不能耐受静脉穿刺者，或有晕针晕血史者；
7) 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，或尿液成瘾药物吗啡、甲基安非他明（冰毒）、氯胺酮、二亚甲基双氧安非他明（摇头丸）、四氢大麻酚酸（大方案编号：HZCG-2024-B0910-41 版本号：V1-广州医科大学附属番禺中心医院版本日期：2024/09/10 45 / 70 麻）筛查试验任何一项或多项结果为阳性者；
8) 筛选前3个月内参加过或正在参加其他的药物临床试验者；
9) 筛选前3个月内献血包括成分血或大量失血（≥400mL），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) 女性处在妊娠期、哺乳期，或女性在计划给药前14天内有未保护性行为或血妊娠检查结果阳性者；
11) 给药前1个月内使用了任何与巴瑞替尼有潜在相互作用的药（如：免疫抑制药物：硫唑嘌呤、他克莫司或环孢素等；转运蛋白：丙磺舒、来氟米或来氟米特、布洛芬、双氯芬酸、地高辛等；细胞色素P450酶：酮康唑、氟康唑、辛伐他汀、炔雌醇或左炔诺孕酮等；胃pH调节剂：奥美拉唑）；
12) 给药前14天内使用过任何处方药、非处方药、中草药和维生素者；
13) 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) 筛选前3个月内每日吸烟量大于5支，或试验期间不能停止使用任何烟草类产品者；
15) 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），或酒精测试阳性者，或不同意在试验期间避免饮酒者；
16) 在筛选前3个月内每天饮用过量浓茶、咖啡和/或含咖啡因的饮料（8杯以上，1杯 =250mL）；
17) 在服药前48h内摄取过浓茶、巧克力、咖啡或含咖啡因、含酒精、含黄嘌呤（如凤尾鱼、沙丁鱼、牛肝、牛肾等）、葡萄柚（汁）或西柚（汁）的食物或饮料者；
18) 对饮食有特殊要求，不能接受统一饮食（如不能耐受牛奶、鸡蛋、黄油、培根等食物）者；
19) 肌酐清除率＜ 80mL/min 且由临床医师判断为有临床意义者【肌酐清除率 (mL/min)=[(140-年龄)×体重(kg)]/[72×Scr(mg/dl)]或肌酐清除率(mL/min)=[(140-年龄)×体重(kg)]/[0.818×Scr(μmol/L)]，女性受试者按计算结果×0.85】；
20) 新冠筛查结果为阳性者；
21) 体格检查、生命体征检查异常且由临床医师判断为有临床意义者；
22) 实验室检查、12-导联心电图检查、胸部正位异常并经临床医师判断有临床意义者；
23) 人类免疫缺陷病毒（HIV）抗体、乙型肝炎病毒表面抗原（HBsAg）或丙型肝炎病毒（HCV）抗体、梅毒螺旋体抗体（Anti-TP）任何一项或多项检查结果为阳性者；
24) 在研究前筛选阶段或研究用药前发生急性疾病者；
25) 其它研究者判定不适宜参加本项临床研究的受试者。

Exclusion criteria：

1. Known allergy to any drug, food, etc., or history of specific allergic reactions (such as asthma, rubella, eczema) Sexual dermatitis) or severe allergic constitution, and the investigator judged clinical significance; 2. Have a history of dysphagia or any gastrointestinal disease that affects drug absorption; 3. There is any blood circulation system, digestive system, urinary system, respiratory system, nervous system, immune system Any history of chronic or serious medical conditions, such as endocrine, mental, or metabolic disorders, that may interfere with the test Test results for any other disease, or previous or existing history of tuberculosis, or history of surgery within 3 months; 4. Patients with shingles within 3 months before screening; 5. Risk factors for deep vein thrombosis or pulmonary embolism, such as advanced age, obesity, deep vein thrombosis or pulmonary embolism Patients with history of obstruction or VTE risk score (based on Caprini model) > 2; 6. Poor vascular puncture conditions, or can not tolerate venous puncture, or have a history of fainting needle and fainting blood; 7. Those with a history of drug abuse in the 6 months prior to screening, or who have used drugs in the 3 months prior to screening, including for non-medical purposes Repeated, heavy use of various narcotic drugs and psychotropic substances, or urine addiction drugs morphine, methamphetamine Positive results for any one or more of the screening tests for tamine (methamphetamine), ketamine, dimethylene dioxyamphetamine (ecstasy), tetrahydrocannabinol (cannabis); 8. Participants who have participated in or are participating in other drug clinical trials within 3 months before screening; 9. Blood donation within 3 months prior to screening includes constituent blood or large blood loss (≥400mL), receiving blood transfusion or using blood products This; Or intends to donate blood (including blood components) during or within 3 months after the end of the trial; 10. The woman is pregnant, breastfeeding, or the woman has unprotected sex or a blood pregnancy in the 14 days prior to the planned dosing Those with positive test results; 11. Use of any drug with potential interaction with baritinib within 1 month prior to administration (e.g., immunosuppressive drugs: Azathioprine, tacrolimus or cyclosporine; Transporters: Prosulfa, leflunomide or leflunomide, Burol Fen, diclofenac, digoxin, etc.; Cytochrome P450 enzymes: ketoconazole, fluconazole, simvastatin, ethinylestradiol Alcohol or levonorgestrel; Gastric pH regulator: omeprazole); 12. Have used any prescription drugs, over-the-counter drugs, Chinese herbs and vitamins within 14 days prior to administration; 13. Those who received vaccination within 3 months prior to screening, or who plan to receive vaccination during the trial; 14. Smoking more than 5 cigarettes per day in the 3 months prior to screening, or not stopping the use of any tobacco products during the trial This; 15. Average alcohol intake of more than 2 units per day in the 3 months prior to screening (1 unit =360mL beer, or 150mL Red wine, or 45mL distilled liquor), or those who tested positive for alcohol or did not agree to avoid drinking alcohol during the test; 16. Excessive consumption of strong tea, coffee, and/or caffeinated beverages per day (more than 8 cups, 1 cup) in the 3 months prior to screening =250mL); 17. Ingested strong tea, chocolate, coffee, or caffeine, alcohol, or xanthine (such as phoenix) within 48 hours before taking the drug Food or drink of tail fish, sardines, ox liver, ox kidney, etc.), grapefruit (juice) or grapefruit (juice); 18. Have special requirements for diet, can not accept unified diet (such as can not tolerate milk, eggs, butter, bacon, etc Food). 19. Creatinine clearance rate < 80mL/min and was judged by clinical doctors as having clinical meaning [creatinine clearance rate] (mL/min) = [(140 - age) by weight (kg)] / [72 x Scr (mg/dl)] or creatinine clearance (mL/min) = [(140 - years Age)× body weight (kg)]/[0.818×Scr(μmol/L)], calculated results for female subjects ×0.85]; 20. Patients with positive screening results for COVID-19; 21. Abnormal physical examination and vital signs examination and judged by clinicians to be clinically significant; 22. Laboratory examination, 12-lead electrocardiogram examination, chest orthostatic abnormality and the judgment of clinicians have clinical significance This; 23. Antibodies to human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg), or hepatitis C Test positive for any one or more of the HCV antibodies and treponema pallidum antibodies (Anti-TP) This; 24. Acute disease occurred during the pre-study screening stage or before the study medication; 25. Subjects determined by other investigators to be unsuitable for participation in this clinical study.

研究实施时间：

Study execute time：

从 From 2024-12-10 00:00:00至 To 2025-12-10 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-12-11 00:00:00 至 To 2024-12-14 00:00:00

干预措施：

Interventions：

组别：	R-T组(空腹）	样本量：	11
Group：	R-T group (fasting)	Sample size：	11
干预措施：	第一周期受试者空腹口服参比制剂（R）4mg（1片），7天后受试者空腹口服受试制剂（T）4mg（1片）。	干预措施代码：
Intervention：	In the first cycle, the subjects took the reference formulation (R) 4mg(1 tablet) orally while fasting, and after 7 days, the subjects took the test formulation (T) 4mg(1 tablet) orally while fasting.	Intervention code：

组别：	T-R组（空腹）	样本量：	11
Group：	T-R group (fasting)	Sample size：	11
干预措施：	第一周期受试者空腹口服受试制剂（T）4mg（1片），7天后受试者空腹口服参比制剂（R）4mg（1片）。	干预措施代码：
Intervention：	In the first cycle, the subjects took the test formulation (T) 4mg (1 tablet) orally while fasting, and after 7 days, the subjects took the reference formulation (R) 4mg (1 tablet) orally while fasting.	Intervention code：

组别：	T-R组（餐后）	样本量：	13
Group：	T-R group (after meals)	Sample size：	13
干预措施：	第一周期受试者空腹口服受试制剂（T）4mg（1片），7天后受试者空腹口服参比制剂（R）4mg（1片）。	干预措施代码：
Intervention：	In the first cycle, the subjects took the test formulation (T) 4mg (1 tablet) orally while fasting, and after 7 days, the subjects took the reference formulation (R) 4mg (1 tablet) orally while fasting.	Intervention code：

组别：	R-T组（餐后）	样本量：	13
Group：	R-T group (after meals)	Sample size：	13
干预措施：	第一周期受试者空腹口服参比制剂（R）4mg（1片），7天后受试者空腹口服受试制剂（T）4mg（1片）。	干预措施代码：
Intervention：	In the first cycle, the subjects took the reference formulation (R) 4mg(1 tablet) orally while fasting, and after 7 days, the subjects took the test formulation (T) 4mg(1 tablet) orally while fasting.	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：	给药后从0至无穷期间的血药浓度时间曲线下面积	指标类型：	主要指标
Outcome：	AUC0-∞	Type：	Primary indicator
测量时间点：	2周期血样采集后	测量方法：	采用LC-MS/MS法测定
Measure time point of outcome：	After2 cycles of blood sample collection	Measure method：	Determination using LC-MS/MS method

指标中文名：	从给药0h到最后一个可准确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：	2周期血样采集后	测量方法：	采用LC-MS/MS法测定
Measure time point of outcome：	After2 cycles of blood sample collection	Measure method：	Determination using LC-MS/MS method

指标中文名：	血浆药物峰浓度	指标类型：	主要指标
Outcome：	Cmax	Type：	Primary indicator
测量时间点：	2周期血样采集后	测量方法：	采用LC-MS/MS法测定
Measure time point of outcome：	After2 cycles of blood sample collection	Measure method：	Determination using LC-MS/MS 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：

结束

/Completed

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）：

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)：

The statistical unit applies SAS (9.4 or later) to generate a random allocation table using block randomization

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）：	论文发表后一年内，国家生物信息中心 https://ngdc.cncb.ac.cn/gsa
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Within one year of publication, China Nation center for Bioinformation https://ngdc.cncb.ac.cn/gsa.
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：	2025-09-24 11:33:48