ChiCTR2600120676 版本V1.0 版本创建时间2026/03/18 11:15:33 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：

 ChiCTR2600120676 

最近更新日期：

Date of Last Refreshed on：

 2026-03-18 11:15:28 

注册时间：

Date of Registration：

 2026-03-18 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

开放、单序列、两周期交叉对照评价H021片相对生物利用度的临床研究

Public title：

An open-label, single-sequence, two-period crossover comparative bioavailability study of H021 tablets

注册题目简写：

English Acronym：

研究课题的正式科学名称：

开放、单序列、两周期交叉对照评价H021片相对生物利用度的临床研究

Scientific title：

An open-label, single-sequence, two-period crossover comparative bioavailability study of H021 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：

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 18343113983

研究负责人电话：

Study leader's
telephone：

+86 571 56131317

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：

中国浙江省杭州市拱墅区东新路848号

研究负责人通讯地址：

中国浙江省杭州市拱墅区东新路848号

Applicant address：

848 Dongxin Road, Gongshu District, Hangzhou, Zhejiang, China

Study leader's address：

848 Dongxin Road, Gongshu District, Hangzhou, Zhejiang, 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：

树兰（杭州）医院

Applicant's institution：

Shulan (Hangzhou) Hospital

研究负责人所在单位：

树兰（衢州）医院

Affiliation of the Leader：

SHULAN(QUZHOU)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：

 2026伦审第（3）号（2026.01.30）

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：

 2026-01-30 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：

中国浙江省杭州市拱墅区东新路848号

Contact Address of the ethic committee：

848 Dongxin Road, Gongshu District, Hangzhou, Zhejiang, China

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：

中国浙江省杭州市拱墅区东新路848号

Primary sponsor's address：

848 Dongxin 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)：

浙江

市(区县)：

Country：

China

Province：

Zhejiang

City：

单位(医院)：

树兰（杭州）医院

具体地址：

中国浙江省杭州市拱墅区东新路848号

Institution
hospital：

Shulan (Hangzhou) Hospital

Address：

848 Dongxin Road, Gongshu District, Hangzhou, Zhejiang, China

经费或物资来源：

江苏柯菲平医药股份有限公司

Source(s) of funding：

Jiangsu Kefei Ping Pharmaceutical Co., Ltd.

研究疾病：

溃疡性结肠炎  

Target disease：

UC(ulcerative colitis)

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：

单臂 

Study design：

Single arm 

研究目的：

研究目的： 主要目的： 考察单次口服H021片（T）在中国健康受试者中的安全性和耐受性； 考察单次口服H021片（T）相较于H021片（R）的相对生物利用度（基于AUC0-t）。 次要目的： 考察单次口服H021片（T）在中国健康受试者体内的药代动力学； 考察单次口服H021片（T）相较于H021片（R）的相对生物利用度（基于Cmax、AUC0-∞）。  

Objectives of Study：

Study Objectives:Main Objectives:To evaluate the safety and tolerability of a single oral dose of H021 tablets (T) in healthy Chinese subjects;To determine the relative bioavailability of a single oral dose of H021 tablets (T) compared to H021 tablets (R) based on AUC0-t.Secondary Objectives:To investigate the pharmacokinetics of a single oral dose of H021 tablets (T) in healthy Chinese subjects;To determine the relative bioavailability of a single oral dose of H021 tablets (T) compared to H021 tablets (R) based on Cmax and AUC0-∞.

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.年龄18~55周岁（含18和55周岁）的健康成年受试者（健康是指经病史询问、体格和生命体征检查、胸部X线（正位）、实验室检查和12-导联心电图等检查结果正常或异常但经研究者判断无临床意义），男女兼有； 2.体重男性>=50.0kg，女性>=45.0kg，且体重指数（BMI）：19.0~26.0kg/m2（含19.0和26.0，体重指数BMI=体重（kg）/身高2（m2），保留小数点后1位）； 3.受试者自愿签署知情同意书； 4.受试者承诺自筛选至末次给予试验用药品后6个月内无生育计划、无捐精或捐卵计划，并采取适当的避孕措施，避免自己或伴侣怀孕； 5.受试者有良好的生活作息并且能够与研究者保持良好的沟通和遵守临床试验的各种要求。

Inclusion criteria

1.Healthy adult subjects aged 18 to 55 years old (inclusive of 18 and 55 years old) (health refers to normal or abnormal results of medical history inquiry, physical examination and vital signs, chest X-ray (orthopside), laboratory tests, and 12-lead electrocardiogram, etc., with the exception that the results have no clinical significance as judged by the researchers), both male and female are included. 2.For males, the weight should be >= 50.0 kg; for females, it should be >= 45.0 kg. Additionally, the body mass index (BMI) should be within the range of 19.0 to 26.0 kg/m2 (including 19.0 and 26.0. The BMI is calculated as weight (kg) divided by the square of height (m2), with the result rounded to one decimal place). 3.The subjects voluntarily signed the informed consent form. 4.The subjects have committed to having no plans for pregnancy, sperm donation or egg donation within 6 months from the screening stage until the last administration of the test drug, and to take appropriate contraceptive measures to prevent themselves or their partners from getting pregnant. 5.The subjects had a regular lifestyle and were able to maintain good communication with the researchers as well as comply with all the requirements of the clinical trial.

排除标准：

1.有神经系统、心血管系统、血液和淋巴系统、免疫系统、肾脏、肝脏、胃肠道、呼吸系统、代谢及骨骼等系统疾病、感染性疾病、重要脏器疾病或病史，且研究者认为会影响受试者安全； 2.有临床意义的食物、药物过敏史或特应性变态反应性疾病史（如哮喘、荨麻疹、湿疹性皮炎等）或已知对试验用药品成分及辅料过敏者； 3.在筛选前3个月内接受过手术，或者计划在研究期间进行手术者； 4.存在可能显著影响药物吸收、分布、代谢和排泄的任何疾病或病史，或者可能对受试者构成危害的任何病情，如： i.筛选时有炎症性肠病、胃溃疡、十二指肠溃疡、胃肠道/直肠出血、持久性恶心或其他具有临床意义的胃肠道异常； ii.既往有较大的胃肠道手术史（比如：胃切除术、胃肠吻合术、肠切除术、胃旁路术、胃分割术或胃囊带术、胆囊切除术，但阑尾炎手术和脱肛术除外）； iii.筛选时有肝病或具有肝功能不全的病史或证据（如AST、ALT或总胆红素＞1.5倍ULN）； iv.筛选时有肾病或具有肾功能不全的病史或证据，表现为有临床意义的肌酐异常或尿成分异常（比如蛋白尿等）； 5.筛选前3个月内饮用过量（平均一天8杯以上，1杯=250 mL）茶、咖啡或含咖啡因的饮料；或给药前48h内，摄取茶或任何含有咖啡因的食物或饮料（如咖啡、巧克力等）者； 6.筛选前3个月内平均每日吸烟超过5支；或在整个试验期间不能禁止吸烟者； 7.筛选前3个月内经常饮酒者，即平均每天饮用超过2个单位的酒精（1单位=360mL啤酒或45mL酒精量为40%的烈酒或150mL葡萄酒）；或试验期间不能禁酒者；或酒精呼气试验呈阳性者； 8.筛选前3个月内献血或失血>=400mL（女性生理性失血除外）；或接受输血或使用血制品；或计划服药期间及停药后3个月内献血者； 9.筛选前3个月内服用过毒品；或12个月内有药物滥用史/依赖史；或筛选时尿药筛查呈阳性者； 10.筛选前3个月内接种过疫苗；或试验结束后3个月内计划接种疫苗者； 11.筛选前3个月内参加过其他药物或器械临床试验且接受试验用药品或器械治疗者； 12.筛选前14天内摄入大量富含葡萄柚（即西柚）的饮料或食物（如葡萄柚、葡萄柚汁、葡萄柚果酱等）；或给药前48 h内，摄入过任何富含葡萄柚（即西柚）的饮料或食物者； 13.筛选前14天内使用过任何处方药、非处方药、中草药或保健品者； 14.病毒学检查，即乙肝表面抗原定性、丙型肝炎病毒抗体、丙型肝炎病毒核心抗原、人免疫缺陷病毒抗原抗体联合检测、梅毒螺旋体特异抗体检查，异常有临床意义者； 15.既往有结核病史；或有任何活动性结核（TB）者； 16.不能耐受静脉穿刺；或有晕针、晕血史者； 17.女性受试者正处在哺乳期或妊娠期；或血妊娠检查结果呈阳性者； 18.对饮食有特殊要求，不能接受统一饮食（包括乳糖不耐受等）；或有吞咽困难者； 19.受试者可能因为其他原因不能完成本研究；或研究者认为受试者存在其他不适于参与该项研究的情况。

Exclusion criteria：

1.There are diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidneys, liver, gastrointestinal tract, respiratory system, metabolism and bones, as well as infectious diseases, diseases of important organs or medical histories, and the researchers believe that these will affect the safety of the subjects.
2.Those with a clinically significant history of food or drug allergies, or atopic allergic diseases (such as asthma, urticaria, eczema, etc.) or those who are known to be allergic to the ingredients and excipients of the investigational drug;
3.Those who had undergone surgery within the previous 3 months, or those who plan to undergo surgery during the study period;
4.Any disease or medical history that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or any condition that may pose a risk to the subject, such as: i. Inflammatory bowel disease, gastric ulcer, duodenal ulcer, gastrointestinal/rectal bleeding, persistent nausea or other clinically significant gastrointestinal abnormalities at the time of screening; ii. A history of major gastrointestinal surgery (such as: gastrectomy, gastroenterostomy, intestinal resection, gastric bypass, gastric division or gastric sac banding, cholecystectomy, but appendicitis surgery and rectal prolapse surgery are excluded); iii. Liver disease or a history or evidence of liver dysfunction at the time of screening (such as AST, ALT or total bilirubin > 1.5 times ULN); iv. Kidney disease or a history or evidence of renal dysfunction at the time of screening, manifested by clinically significant creatinine abnormalities or abnormal urine components (such as proteinuria, etc.).
5.Exclude those who have consumed excessive amounts (an average of more than 8 cups per day, 1 cup = 250 mL) of tea, coffee or caffeinated beverages within the previous 3 months; or those who consumed tea or any food or beverage containing caffeine (such as coffee, chocolate, etc.) within 48 hours before administration.
6.Those who smoked an average of more than 5 cigarettes per day over the past 3 months; or those who were unable to refrain from smoking throughout the entire trial period.
7.Select those who frequently consumed alcohol within the previous 3 months, that is, those who consumed more than 2 units of alcohol per day on average (1 unit = 360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine); or those who were unable to abstain from alcohol during the trial; or those whose alcohol breath test was positive.
8.Screen those who have donated blood or lost blood by more than 400 mL within the past 3 months (excluding physiological blood loss in women); or have received blood transfusion or used blood products; or are scheduled to donate blood during the medication period and within 3 months after discontinuation of the medication.
9.Those who have taken drugs within the past 3 months; or have a history of drug abuse or dependence within the past 12 months; or those whose urine drug test is positive at the time of screening.
10.Those who received the vaccine within the past 3 months; or those who plan to receive the vaccine within the next 3 months after the trial.
11.Select those who have participated in other clinical trials of drugs or devices within the past three months and have received treatment with the trial drugs or devices.
12.Exclude those who have consumed a large amount of beverages or foods rich in grapefruit (such as grapefruit, grapefruit juice, grapefruit jam, etc.) within the previous 14 days; or those who have consumed any beverages or foods rich in grapefruit (i.e. grapefruit) within 48 hours before administration.
13.Exclude those who have used any prescription drugs, over-the-counter drugs, herbal medicines or health supplements within the past 14 days.
14.Viral testing, including qualitative detection of hepatitis B surface antigen, hepatitis C virus antibody, hepatitis C virus core antigen, combined detection of human immunodeficiency virus antigen and antibody, and specific antibody test for Treponema pallidum, for those with abnormal results of clinical significance;
15.Have a history of tuberculosis; or have any active tuberculosis (TB).
16.Unable to tolerate venipuncture; or those with a history of fainting during injections or blood transfusions;
17.The female subjects are in the lactation period or pregnancy period; or those whose blood pregnancy test results are positive.
18.Have special dietary requirements and cannot accept a uniform diet (including lactose intolerance, etc.); or have difficulty in swallowing.
19.The participants may not be able to complete this study for other reasons; or the researchers may deem that the participants have other conditions that make them unsuitable to participate in this research.

研究实施时间：

Study execute time：

从 From 2026-03-19 00:00:00至 To 2027-03-19 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-03-20 00:00:00 至 To 2027-03-18 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 10

Group：

Trial group

Sample size：

干预措施：

受试者至少隔夜禁食10h后，将空腹单次给予试验药物（H021片（T）），清洗期后给予对照药物（H021片（R））

干预措施代码：

Intervention：

After the subjects fasted for at least 10 hours overnight, the test drug (H021 tablets (T)) was administered in a single dose on an empty stomach. Aft

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)：

  

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：

相对生物利用度（基于 AUC0-t）

指标类型：

主要指标

Outcome：

Relative Bioavailability (based on AUC0-t)

Type：

Primary indicator

测量时间点：

D1~D14

测量方法：

Measure time point of outcome：

Days 1 to 14

Measure method：

指标中文名：

相对生物利用度（基于 Cmax、AUC0-∞）

指标类型：

次要指标

Outcome：

Relative Bioavailability (based on Cmax and AUC0-∞)

Type：

Secondary indicator

测量时间点：

D1~D14

测量方法：

Measure time point of outcome：

Days 1 to 14

Measure method：

指标中文名：

药代动力学参数（包括 H021 及代谢产物 M2 的 AUC0-∞、AUC0-t、Cmax、Tmax、Tlag、Kel、MRT、t1/2、CL/F、Vd/F、AUC_%Extrap）

指标类型：

主要指标

Outcome：

Pharmacokinetic Parameters (including AUC0-∞, AUC0-t, Cmax, Tmax, Tlag, Kel, MRT, t1/2, CL/F, Vd/F, and AUC_%Extrap for H021 and metabolite M2)

Type：

Primary indicator

测量时间点：

D1~D14

测量方法：

Measure time point of outcome：

Days 1 to 14

Measure method：

指标中文名：

安全性指标（包括：不良事件、生命体征（呼吸频率、坐位血压、脉搏和耳温）、体格检查、实验室检查（血常规、尿常规、血生化、凝血功能常规检查）、血妊娠检查和 12-导联心电图检查）

指标类型：

副作用指标

Outcome：

Safety Outcomes (including adverse events, vital signs (respiratory rate, sitting blood pressure, pulse rate, and ear temperature), physical examination, laboratory tests (complete blood count, urinalysis, blood biochemistry, coagulation function tests), blood pregnancy test, and 12-lead electrocardiogram)

Type：

Adverse events

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：

PK血样

组织：

Sample Name：

PK blood sample

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 55 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:

不公开/Private

盲法：

无

Blinding：

None

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：

原始病历、电子统计系统

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

Original medical records, electronic statistics system

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-03-18 11:15:28