ChiCTR2500114078 版本V1.0 版本创建时间2025/12/08 09:02:25 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：

 ChiCTR2500114078 

最近更新日期：

Date of Last Refreshed on：

 2025-12-08 09:02:19 

注册时间：

Date of Registration：

 2025-12-08 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

随机、开放、单剂量、两制剂、两序列、两周期、双交叉对照设计，评价餐后状态下单次口服受试制剂乌帕替尼缓释片与参比制剂乌帕替尼缓释片（商品名：RINVOQ?/瑞福?）在中国健康受试者中的生物等效性正式试验

Public title：

A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, two-way crossover bioequivalence study to evaluate the bioequivalence of a single oral dose of the test formulation of upadacitinib extended-release tablets and the reference formulation of upadacitinib extended-release tablets (trade name: RINVOQ?/Rifu?) under postprandial conditions in healthy Chinese subjects.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

随机、开放、单剂量、两制剂、两序列、两周期、双交叉对照设计，评价餐后状态下单次口服受试制剂乌帕替尼缓释片与参比制剂乌帕替尼缓释片（商品名：RINVOQ?/瑞福?）在中国健康受试者中的生物等效性正式试验

Scientific title：

A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, two-way crossover bioequivalence study to evaluate the bioequivalence of a single oral dose of the test formulation of upadacitinib extended-release tablets and the reference formulation of upadacitinib extended-release tablets (trade name: RINVOQ?/Rifu?) under 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：

陈桂玲 

研究负责人：

陈桂玲 

Applicant：

Chen Guiling 

Study leader：

Chen Guiling 

申请注册联系人电话：

Applicant telephone：

 +86 571 5613 1317

研究负责人电话：

Study leader's
telephone：

+86 571 5613 1317

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：

 chenguiling707@126.com

研究负责人电子邮件：

Study leader's E-mail：

 guiling.chen@shulan.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东新路848号

研究负责人通讯地址：

浙江省杭州市东新路836、848号

Applicant address：

No. 848, Dongxin Road, Gongshu District, Hangzhou City, Zhejiang Province

Study leader's address：

No. 848, Dongxin 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：

树兰（杭州）医院

Applicant's institution：

Shulan (Hangzhou) Hospital

研究负责人所在单位：

树兰（杭州）医院

Affiliation of the Leader：

Shulan (Hangzhou) Hospital

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伦审第(39)号

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：

树兰（杭州）医院临床试验伦理委员会

Name of the ethic committee：

Clinical Trial Ethics Review Committee of Shulan (Hangzhou) Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-11-12 00:00:00

伦理委员会联系人：

管文花

Contact Name of the ethic committee：

Guan Wenhua

伦理委员会联系地址：

浙江省杭州市拱墅区东新路848号

Contact Address of the ethic committee：

No. 848, Dongxin Road, Gongshu District, Hangzhou City, Zhejiang Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 571 56131318

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 wenhua.guan@shulan.com

研究实施负责（组长）单位：

树兰（杭州）医院

Primary sponsor：

Shulan (Hangzhou) Hospital

研究实施负责（组长）单位地址：

浙江省杭州市拱墅区东新路848号

Primary sponsor's address：

No. 848, Dongxin Road, Gongshu District, Hangzhou City, Zhejiang 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)：

浙江省

市(区县)：

Country：

China

Province：

Zhejiang

City：

单位(医院)：

树兰（杭州）医院

具体地址：

浙江省杭州市拱墅区东新路848号

Institution
hospital：

Shulan (Hangzhou) Hospital

Address：

No. 848, Dongxin Road, Gongshu District, Hangzhou City, Zhejiang Province

经费或物资来源：

山西泽辰医药科技有限公司

Source(s) of funding：

Shanxi Zechen Pharmaceutical Technology Co., Ltd.

研究疾病：

特应性皮炎  

Target disease：

Atopicdcrmatis

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：

主要研究目的 研究餐后状态下单次口服受试制剂乌帕替尼缓释片（规格：15mg，山西鑫煜制药股份有限公司生产）与参比制剂乌帕替尼缓释片（RINVOQ?/瑞福?，规格：15mg；AbbVie Ireland NL B.V.生产）在健康受试者体内的药代动力学，评价餐后状态口服两种制剂的生物等效性。 次要研究目的 研究受试制剂乌帕替尼缓释片和参比制剂乌帕替尼缓释片在健康受试者中的安全性。  

Objectives of Study：

Main research objective:To investigate the pharmacokinetics of the test formulation upatidenol sustained-release tablets (specification: 15mg, produced by Shanxi Xinyu Pharmaceutical Co., Ltd.) and the reference formulation upatidenol sustained-release tablets (RINVOQ?/Rifu?, specification: 15mg; produced by AbbVie Ireland NL B.V.) in healthy subjects after a single oral administration, and to evaluate the bioequivalence of the two formulations in the post-meal state.Secondary research objective:To study the safety of the test formulation upatidenol sustained-release tablets and the reference formulation upatidenol sustained-release tablets 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：

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； 2.能够按照试验方案要求完成研究； 3.受试者（包括伴侣）自给药前2周至最后一次研究药物给药后6个月内无妊娠计划且自愿采取有效避孕措施，具体避孕措施见附录5； 4.年龄为18周岁及以上健康男性和女性受试者（包括18周岁）； 5.男性受试者体重不低于50公斤、女性受试者体重不低于45公斤。体重指数（BMI）＝体重（kg）/身高（m^2），体重指数在19.0～26.0kg/m^2范围内（包括临界值）； 6.体格检查、生命体征正常或异常无临床意义。

Inclusion criteria

1.Before the trial, sign the informed consent form and fully understand the content, process and possible adverse reactions of the trial. 2. Be capable of completing the research in accordance with the requirements of the test plan; 3. The subjects (including their partners) had no pregnancy plans from 2 weeks before self-administration of the drug to 6 months after the last administration of the study drug and voluntarily adopted effective contraceptive measures. The specific contraceptive measures are detailed in Appendix 5. 4. Healthy male and female subjects aged 18 and above (including 18 years old); Male subjects should weigh no less than 50 kilograms and female subjects no less than 45 kilograms. Body mass Index (BMI) = weight (kg)/height (m^2). The BMI should be within the range of 19.0 to 26.0kg/m^2 (including the critical value). 6. Normal or abnormal physical examination and vital signs have no clinical significance.

排除标准：

1.筛选前三个月内使用过任何临床试验药物或入组任何药物/医疗器械临床试验者；
2.对试验药品组分或类似物有过敏史，过敏体质（两种或两种以上药物及食物过敏）；
3.筛选前3个月每日吸烟量多于5支者，或试验期间不能停止使用任何烟草类产品者；
4.筛选前3个月内接受过大手术或者计划在试验结束后3个月内接受手术；
5.筛选前6个月内经常饮酒者，即每周饮酒超过14单位酒精（1单位=360mL啤酒或45mL酒精量为40%的烈酒或150mL葡萄酒），或者不能保证试验期间放弃饮酒者；
6.筛选前3个月内献血或大量失血（＞450mL）（不包括女性生理期失血量），接受输血或使用血制品者，试验期间计划献血者；
7.筛选前3个月内接受过JAK抑制剂、生物免疫调节剂或其他免疫抑制剂治疗者；
8.筛选前14天内服用了任何处方药、非处方药、任何维生素产品或草药；
9.筛选前1个月内服用了任何改变肝酶活性的药物，或合并有以下CYP3A4、CYP2D6、P-gp或Bcrp的抑制剂或诱导剂，如伊曲康唑、酮康唑或决奈达隆等；
10.筛选前1个月内接种疫苗或减毒活疫苗，或计划在试验期间接种疫苗者；
11.筛选前2周内服用过特殊饮食（包括火龙果、芒果、柚子等）或有剧烈运动，或其他影响药物吸收、分布、代谢、排泄等因素者；
12.有吞咽困难、不能整片吞服药物者；
13.对食物有特殊要求，不能遵守统一饮食或不能耐受标准餐；
14.有慢性或复发性感染，或具有严重或机会性感染史，或筛选前6个月发生过全身感染（包括带状疱疹、播散性单纯疱疹等病毒感染），或曾在结核病流行区或真菌病流行区居住或旅行者；
15.有结核病史、肿瘤家族史或重度肝功能损害者；
16.心电图异常有临床意义；
17.女性受试者在筛查期或试验过程中正处在哺乳期或血清妊娠结果阳性；
18.临床实验室检查（血生化、血常规、尿常规、凝血功能检查）、胸部正位片检查异常有临床意义；
19.有心血管系统、消化系统、泌尿生殖系统、呼吸系统、血液系统、内分泌系统、免疫系统、精神神经系统、骨骼系统等慢性疾病或严重疾病史；特别是患有胃肠功能障碍、消化性溃疡、胃肠手术等影响药物吸收、分布、代谢和排泄的疾病史或手术史；
20.乙肝表面抗原定性、丙型肝炎病毒抗体、丙型肝炎病毒核心抗原、人免疫缺陷病毒（HIV）抗原抗体联合检测、梅毒螺旋体特异性抗体测定任一检查结果阳性者；
21.在服用研究药物前24小时摄取了巧克力、任何含咖啡因或富含黄嘌呤食物或饮料；
22.在服用研究用药前24小时内服用过任何含酒精的制品或酒精呼气测试阳性；
23.尿液药物筛查阳性者或在过去五年内有药物滥用史；
24.晕针、晕血或静脉采血困难者；
25.从筛选阶段至服药前发生急性疾病或有伴随用药；
26.受试者可能因为其他原因而不能完成本试验或经研究者判断认为不适合参加本项试验。

Exclusion criteria：

1.Select those who have used any clinical trial drugs within the past three months or have participated in any clinical trials of drugs or medical devices.
2.Have a history of allergies to the components of the test drug or its analogues, or have an allergic constitution (allergic to two or more drugs and foods);
3.Select those who smoked more than 5 cigarettes per day in the previous 3 months, or those who were unable to stop using any tobacco products during the trial period;
4.Exclude those who have undergone major surgery within the past 3 months or who plan to undergo surgery within 3 months after the end of the trial;
5.Select individuals who have consumed alcohol frequently within the past 6 months, that is, those who have consumed more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine), or those who cannot guarantee to give up alcohol during the trial period;
6.Exclude individuals who have donated blood within the past 3 months or who have experienced significant blood loss (more than 450 mL) (excluding menstrual blood loss for women), those who have received blood transfusions or used blood products, and those who plan to donate blood during the trial period.
7.Exclude those who have received treatment with JAK inhibitors, biological immunomodulators, or other immunosuppressants within the past 3 months;
8.Have taken any prescription drugs, over-the-counter drugs, any vitamin products or herbal remedies within the past 14 days?;
9.Subjects who have taken any drugs that alter liver enzyme activity within the past 1 month, or who are concurrently using any inhibitors or inducers of CYP3A4, CYP2D6, P-gp or Bcrp, such as itraconazole, ketoconazole or dronedarone, etc., will be excluded from the study.
10.Exclude those who received vaccinations or attenuated live vaccines within the previous 1 month, or those who plan to receive vaccinations during the trial period;
11.Exclude those who have taken special diets (such as dragon fruit, mango, grapefruit, etc.) within the past two weeks, or have engaged in intense exercise, or have any other factors that may affect the absorption, distribution, metabolism, or excretion of the drug;
12.Those who have difficulty in swallowing and are unable to take the medicine in its entirety;
13.Have special dietary requirements and cannot follow a uniform diet or cannot tolerate standard meals;
14.Those with chronic or recurrent infections, or with a history of severe or opportunistic infections, or who have experienced systemic infections within the previous 6 months (including herpes zoster, disseminated herpes simplex virus infections, etc.), or who have resided or traveled in areas with a tuberculosis epidemic or fungal disease epidemic;
15.Those with a history of tuberculosis, a family history of tumors, or severe liver dysfunction;
16.Abnormalities in electrocardiogram have clinical significance.
17.Female subjects were in the lactation period or were experiencing a positive serum pregnancy test result during the screening period or the trial process;
18.Clinical laboratory tests (blood biochemistry, blood routine, urine routine, coagulation function tests), and abnormal findings in chest X-ray examinations have clinical significance.
19.Have a history of chronic or severe diseases in the cardiovascular system, digestive system, urinary reproductive system, respiratory system, blood system, endocrine system, immune system, nervous system, and skeletal system; especially having a history of diseases or surgeries that affect drug absorption, distribution, metabolism and excretion, such as gastrointestinal dysfunction, peptic ulcers, gastrointestinal surgeries, etc.
20.Anyone whose test results for hepatitis B surface antigen determination, hepatitis C virus antibody, hepatitis C virus core antigen, human immunodeficiency virus (HIV) antigen-antibody combination detection, or syphilis spirochete-specific antibody are positive;
21.Within 24 hours prior to taking the study medication, consumed chocolate, any food or beverage containing caffeine or rich in xanthine.
22.Within 24 hours prior to taking the study medication, had consumed any alcoholic products or had a positive alcohol breath test;
23.Those with a positive result in urine drug screening or who have a history of drug abuse in the past five years;
24.Those who experience dizziness during acupuncture, blood transfusion, or have difficulty with venous blood collection;
25.From the screening stage until the onset of acute illness or the initiation of concomitant medication;
26.The subjects may be unable to complete this trial for other reasons, or may be deemed unsuitable by the researchers to participate in this trial.

研究实施时间：

Study execute time：

从 From 2025-12-05 00:00:00至 To 2026-12-05 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-12-08 00:00:00 至 To 2025-12-09 00:00:00

干预措施：

Interventions：

组别：

RT组

样本量：

 18

Group：

RT Group

Sample size：

干预措施：

餐后试验健康受试者在服药前 30min（+/-1min）开始进食标准餐，控制进餐速度，服药前结束即可，然后服用相应参比制剂。之后隔 5 天交叉给药进行第二周期研究，第二周期的服药时间与第一周期一致，并于第二周期给药后 48h 行出组检查

干预措施代码：

Intervention：

In the postprandial test, healthy subjects should start having a standard meal 30 minutes (+/-1 minute) before taking the medicine, control the eating speed, and finish the meal before taking the medicine, then take the corresponding reference preparation. Then, cross-administration was conducted every 5 days for the second cycle study. The administration time of the second cycle was the same as that of the first cycle, and a group exit examination was performed 48 hours after the administration of the second cycle

Intervention code：

组别：

TR组

样本量：

 18

Group：

TR Group

Sample size：

干预措施：

餐后试验健康受试者在服药前 30min（+/-1min）开始进食标准餐，控制进餐速度，服药前结束即可，然后服用相应受试制剂。之后隔 5 天交叉给药进行第二周期研究，第二周期的服药时间与第一周期一致，并于第二周期给药后 48h 行出组检查

干预措施代码：

Intervention：

In the postprandial test, healthy subjects started to have a standard meal 30 minutes (+/-1 minute) before taking the medicine, controlled the eating speed, and finished the meal before taking the medicine. Then they took the corresponding test preparation. Then, cross-administration was conducted every 5 days for the second cycle study. The administration time of the second cycle was the same as that of the first cycle, and a group exit examination was performed 48 hours after the administration of the second cycle

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江省 

市(区县)：

  

Country：

China

Province：

Zhejiang

City：

单位(医院)：

 树兰（杭州）医院 

单位级别：

 三级甲等 

Institution
hospital：

Shulan (Hangzhou) Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

临床实验室检查

指标类型：

次要指标

Outcome：

Laboratory tests

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

药代动力学参数

指标类型：

主要指标

Outcome：

Pharmacokinetic parameters

Type：

Primary 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

 使用后销毁  

说明

Fate of sample：

Destruction 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）：

本研究采用随机、开放、单剂量、两制剂、两序列、两周期、双交叉对照试验设计。随机表由统计单位应用SAS 9.4或以上版本按1:1区组随机产生。采用区组随机方法，将受试者按照1:1的比例随机分配到两组（TR组和RT组）中的某一组。随机化结果中应保留随机化种子，以保证随机化结果的重现性。

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

This study adopted a randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-cross-over controlled trial design. The randomization table was generated by the statistical unit using SAS 9.4 or above version in a block randomization manner. The subjects were randomly assigned to one of the two groups (TR group and RT group) at a 1:1 ratio using the block randomization method. The randomization results should retain the randomization seed to ensure the reproducibility of the randomization results.

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

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：

EDC

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

EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-12-08 09:02:19