ChiCTR2600119475 版本V1.0 版本创建时间2026/02/27 15:17:01 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：

 ChiCTR2600119475 

最近更新日期：

Date of Last Refreshed on：

 2026-02-27 15:16:52 

注册时间：

Date of Registration：

 2026-02-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

评价XY03-EA片在健康研究参与者中对转运体OAT1底物阿德福韦酯人体药代动力学影响的临床研究

Public title：

Clinical study evaluating the impact of XY03-EA tablets on the human pharmacokinetics of the transporter OAT1 substrate adefovir dipivoxil in participants of a health research study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评价XY03-EA片在健康研究参与者中对转运体OAT1底物阿德福韦酯人体药代动力学影响的临床研究

Scientific title：

Clinical study evaluating the impact of XY03-EA tablets on the human pharmacokinetics of the transporter OAT1 substrate adefovir dipivoxil in participants of a health research study

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 56131317

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

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：

 2026伦审第(4)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：

 2026-02-11 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：

浙江省杭州市东新路848号

Contact Address of the ethic committee：

No. 848, Dongxin Road, Gongshu District, Hangzhou

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：

浙江省杭州市东新路848号

Primary sponsor's address：

No. 848, Dongxin Road, Gongshu District, Hangzhou

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：

浙江省杭州市东新路848号

Institution
hospital：

Shulan (Hangzhou) Hospital

Address：

No. 848, Dongxin Road, Gongshu District, Hangzhou

经费或物资来源：

石家庄以岭药业股份有限公司

Source(s) of funding：

Shijiazhuang Yiling Pharmaceutical Co., Ltd

研究疾病：

急性缺血性卒中  

Target disease：

Acute ischemic stroke

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：

单臂 

Study design：

Single arm 

研究目的：

主要目的 评价在健康研究参与者中XY03-EA片对转运体OAT1底物阿德福韦人体内药代动力学的影响程度，初步评价XY03-EA片对转运体OAT1是否有抑制作用，为XY03-EA片与其它药物合用提供参考。 次要目的 1）评价XY03-EA片与转运体OAT1底物阿德福韦酯合用后的安全性； 2）评价单次口服XY03-EA片，XY03-EA及其代谢产物XY03-D的药代动力学特征。  

Objectives of Study：

Main objectiveTo evaluate the extent of the impact of the XY03-EA tablet on the in vivo pharmacokinetics of the substrate of the transporter OAT1, namely adefovir, in healthy research participants, and to preliminarily assess whether the XY03-EA tablet has an inhibitory effect on the transporter OAT1, providing a reference for the combination of XY03-EA tablet with other drugs. Secondary objectives1) To evaluate the safety of the combination of the XY03-EA tablet with the substrate of the transporter OAT1, adefovir;2) To evaluate the pharmacokinetic characteristics of a single oral administration of the XY03-EA tablet, as well as the XY03-EA and its metabolite XY03-D.

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.研究参与者必须在试验前对本试验知情同意，并对试验内容、过程及可能出现的不良反应充分了解，且自愿签署了书面的知情同意书；
2.年龄18~45周岁（含边界值）的中国健康男性或女性参与者；
3.男性参与者体重≥50kg，女性参与者体重≥45kg，且体重指数（BMI）在18.0~26.0 kg/m2之间，BMI=体重（kg）/身高（m2），包括边界值；
4.研究参与者能够与研究者进行良好的沟通并能够依照方案规定完成试验。

Inclusion criteria

1.The research participants must have given their informed consent for the trial before the experiment, fully understood the content, process and possible adverse reactions of the trial, and voluntarily signed a written informed consent form.
2. Male or female participants aged 18 to 45 years old (inclusive of the boundary values), who are healthy Chinese individuals;
3. Male participants had a body weight of 50 kg or more, female participants had a body weight of 45 kg or more, and their body mass index (BMI) was within the range of 18.0 to 26.0 kg/m2 (including the boundary values). BMI = weight (kg) / height (m2).
4. The research participants were able to communicate well with the researchers and were able to complete the trial in accordance with the protocol.

排除标准：

1.过敏体质，如对两种或以上药物、食物和花粉过敏者，和/或已知对研究药物（XY03-EA片及阿德福韦酯片）组分或者其辅料有过敏史者；
2.既往或现患有心源性休克、严重的传导阻滞、病窦综合征、心力衰竭、持续性快速型心律失常、尖端扭转型室速（Tdp)或室性心动过速、有临床意义的T波改变病史、心肌梗死、心绞痛、QT延长综合征史或有长QT综合征症状及家族史者；
3.有任何临床严重疾病史或研究者认为可能影响试验结果的疾病或情况，包括但不限于神经/精神系统、呼吸系统、心脑血管系统、内分泌系统、泌尿系统、血液学、免疫学（包括个人或家族史遗传性免疫缺陷）、消化道系统（有吞咽困难或任何影响药物吸收的胃肠道疾病史）、恶性肿瘤等；
4.患有任何增加出血性风险的疾病，如急性胃炎或胃及十二指肠溃疡等；
5.生命体征、体格检查、实验室检查、12-导联心电图等检查经研究者判定异常有临床意义者；
6.筛选前6个月内接受过重大手术或者手术切口没有完全愈合；重大手术包括但不限于任何有显著出血风险、延长全身麻醉期、或切开活检或明显创伤性损伤的手术者，或计划在试验期间进行外科手术者；
7.筛选前28天内曾使用过任何抑制或诱导肝脏药物代谢酶的药物（如：诱导剂——巴比妥类、卡马西平、苯妥英、糖皮质激素、奥美拉唑；抑制剂——SSRI类抗抑郁药、西咪替丁、地尔硫卓、维拉帕米、大环内酯类、硝基咪唑类、镇静催眠药、氟喹诺酮类、抗组胺类）者；
8.入住研究机构当天药物滥用筛查阳性者；
9.筛选前3个月内参加过任何药物或医疗器械的临床试验者（参加临床试验的定义以研究参与者接受试验药物或医疗器械治疗为准）；
10.有药物滥用史，和/或筛选前3个月内使用过毒品者，和/或习惯性使用任何药物者，包括中草药制剂；
11.筛选期乙肝表面抗原（HBsAg）、丙肝抗体（Anti-HCV）、人类免疫缺陷病毒（HIV）抗体、梅毒抗体（TPPA）检查任意一项阳性者；
12.筛选前3个月内平均每日抽烟5支以上者，或试验期间不能禁烟者；
13.筛选前3个月内经常饮酒者，即每周饮酒超过14个单位的酒精（1单位=10mL乙醇，即1单位=200mL酒精量为5%的啤酒或25mL酒精量为40%的烈酒或83mL酒精量为12%的葡萄酒）或酒精呼气检查阳性者，或试验期间不能禁酒者；
14.试验期间对饮食有特殊要求，不能遵守统一饮食者；
15.筛选前3个月内失血或献血超过400mL者，和/或1个月内献血小板者；
16.筛选前14天内使用过任何药物者；
17.筛选前4周内注射疫苗者，和/或计划在接受研究药物后1个月内接种疫苗者；
18.研究参与者在签署知情同意书后3个月内有妊娠计划（包括捐精、捐卵）和/或不愿采取有效避孕方法者（避孕方式见章节13）；
19.在研究药物给药前48小时直至研究结束，不能控制特殊饮食（包括火龙果、芒果、柚类和/或黄嘌呤饮食，含咖啡因的食品或饮料，浓茶、含酒精类饮料等），剧烈运动，或有其他影响药物吸收、分布、代谢、排泄等因素者；
20.筛选前30天内使用过口服避孕药者；
21.筛选前6个月内使用过长效雌激素和/或孕激素注射剂或埋植片者；
22.育龄女性处于妊娠期或哺乳期，或首次给药前14天内发生非保护性性行为者；
23.研究者认为不适合参加本试验的其他情况，如有可能增加试验风险、影响研究参与者对方案依从性或影响研究参与者完成试验的生理或者心理疾病或状况者。

Exclusion criteria：

1.People with allergic constitution, such as those allergic to two or more drugs, foods and pollen, and/or those with a known history of allergy to the components of the study drugs (XY03-EA tablets and Adefovir Dipivoxil tablets) or their excipients;
2. Those who have had or currently have cardiogenic shock, severe conduction block, sick sinus syndrome, heart failure, persistent rapid arrhythmia, torsade de pointes (Tdp) or ventricular tachycardia, a history of clinically significant T-wave changes, myocardial infarction, angina pectoris, QT prolongation syndrome, or have symptoms or a family history of long QT syndrome;
3. Any history of severe clinical diseases or conditions that the investigator believes may affect the trial results, including but not limited to neurological/spiritual systems, respiratory systems, cardiovascular systems, endocrine systems, urinary systems, hematological systems, immunological systems (including personal or family history of hereditary immune deficiencies), digestive systems (with history of difficulty in swallowing or any gastrointestinal diseases affecting drug absorption), malignant tumors, etc.
4. Have any diseases that increase the risk of bleeding, such as acute gastritis or gastric and duodenal ulcers, etc.
5. Abnormal findings in vital signs, physical examination, laboratory tests, 12-lead electrocardiogram, etc., which have clinical significance as determined by the researchers;
6. Exclusion criteria: Those who have undergone major surgery within the past 6 months or whose surgical incisions have not fully healed; major surgeries include but are not limited to any surgeries with significant bleeding risks, prolonged general anesthesia periods, or incisional biopsies or obvious traumatic injuries, or those who plan to undergo surgery during the trial.
7. Exclude those who have used any drugs that inhibit or induce liver drug-metabolizing enzymes within the past 28 days (such as inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, verapamil, macrolides, nitroimidazoles, sedative-hypnotics, fluoroquinolones, antihistamines).
8. Those who tested positive for drug abuse on the day of admission to the research institution;
9. Select those who have participated in any clinical trials of drugs or medical devices within the past three months (the definition of participation in clinical trials is based on the fact that the research participants received treatment with the trial drugs or medical devices).
10. Those with a history of drug abuse, and/or those who have used drugs within the previous 3 months before screening, and/or those who habitually use any drugs, including herbal preparations;
11. Those who test positive for any one of the following: hepatitis B surface antigen (HBsAg), hepatitis C antibody (Anti-HCV), human immunodeficiency virus (HIV) antibody, or syphilis antibody (TPPA) during the screening period will be included.
12. Select those who smoked an average of more than 5 cigarettes per day in the previous 3 months, or those who were unable to quit smoking during the trial.
13. Select individuals who have consumed alcohol frequently within the past three months, that is, those who have consumed more than 14 units of alcohol per week (1 unit = 10 mL of ethanol, which is equivalent to 1 unit = 200 mL of 5% alcohol beer, 25 mL of 40% alcohol spirits, or 83 mL of 12% alcohol wine) or those with a positive alcohol breath test result, or those who were unable to abstain from alcohol during the trial period.
14. During the experiment, there are specific dietary requirements. Those who cannot follow the unified diet are excluded.
15. Select those who have lost or donated more than 400 mL of blood within the past three months, and/or those who have donated platelets within the past month.
16. Exclude those who have used any medication within the past 14 days;
17. Select those who received vaccinations within the previous 4 weeks, and/or those who plan to receive vaccinations within 1 month after taking the study medication;
18. Participants in the study who had a pregnancy plan (including sperm donation, egg donation) within 3 months after signing the informed consent form and/or who were unwilling to use effective contraceptive methods (contraceptive methods are described in Chapter 13);
19. From 48 hours before the administration of the drug until the end of the study, it is not allowed to follow a special diet (including dragon fruit, mango, citrus fruits and/or xanthine diet, caffeinated foods or beverages, strong tea, alcoholic beverages, etc.), engage in vigorous exercise, or have any other factors that may affect the absorption, distribution, metabolism, or excretion of the drug.
20. Select those who have used oral contraceptives within the past 30 days;
21. Exclude those who have used long-acting estrogen and/or progestin injections or implants within the past 6 months;
22. Women of childbearing age who are currently pregnant or breastfeeding, or who have engaged in unprotected sexual intercourse within 14 days prior to the first administration of the medication;
23. The researchers also identified other circumstances that were not suitable for participation in this trial, such as conditions that might increase the risk of the trial, affect the participants' compliance with the protocol, or cause physical or psychological disorders or conditions that would prevent the participants from completing the trial.

研究实施时间：

Study execute time：

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

征募观察对象时间：

Recruiting time：

从 From 2026-03-04 00:00:00 至 To 2027-03-02 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 14

Group：

Experimental group

Sample size：

干预措施：

D1、D6 早单次口服阿德福韦酯片，D4-D7每8h口服XY03-EA片

干预措施代码：

Intervention：

On days 1 and 6, take a single oral dose of Adefovir Dipivoxil Tablets. From day 4 to day 7, take XY03-EA Tablets every 8 hours.

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：

安全性指标（血常规、尿常规、血生化、凝血功能）

指标类型：

次要指标

Outcome：

Safety indicators (blood routine, urine routine, blood biochemistry, coagulation function)

Type：

Secondary indicator

测量时间点：

筛选、出组或提前退出

测量方法：

采集静脉血、尿液

Measure time point of outcome：

Screening, elimination or early withdrawal

Measure method：

Collecting venous blood and urine

指标中文名：

阿德福韦酯片药代动力学参数

指标类型：

主要指标

Outcome：

Pharmacokinetic parameters of adefovir dipivoxil tablets

Type：

Primary indicator

测量时间点：

给药前0时和给药后15min、30min、1h至给药后48h

测量方法：

采集静脉血

Measure time point of outcome：

At 0 minutes before administration and 15 minutes, 30 minutes, 1 hour, up to 48 hours after administ

Measure method：

Collecting venous blood

指标中文名：

XY03-EA片药代动力学参数

指标类型：

主要指标

Outcome：

Pharmacokinetic parameters of XY03-EA tablet

Type：

Primary indicator

测量时间点：

给药前0时和给药后5min、15min、30min至给药后8h

测量方法：

采集静脉血

Measure time point of outcome：

At 0 minutes before administration and at 5 minutes, 15 minutes, 30 minutes, and up to 8 hours after

Measure method：

Collecting venous blood

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血样

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：

标本中文名：

尿液

组织：

Sample Name：

urine

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 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:

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、电子采集系统

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

Original medical records, electronic collection system

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-02-27 15:16:52