ChiCTR2500112110 版本V1.0 版本创建时间2025/11/10 17:13:50 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：

 ChiCTR2500112110 

最近更新日期：

Date of Last Refreshed on：

 2025-11-10 17:13:45 

注册时间：

Date of Registration：

 2025-11-10 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

磷酸泊沃昔替尼片在中国健康受试者的药代动力学及生物等效性的预试验

Public title：

Pre-clinical study on the pharmacokinetics and bioequivalence of Powdered Bortezomib Tablets in Chinese healthy subjects

注册题目简写：

English Acronym：

研究课题的正式科学名称：

磷酸泊沃昔替尼片在中国健康受试者的药代动力学及生物等效性的预试验

Scientific title：

Pre-clinical study on the pharmacokinetics and bioequivalence of Powdered Bortezomib Tablets in Chinese healthy 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：

谢娇娇 

研究负责人：

陈金亮 

Applicant：

Xie Jiaojiao 

Study leader：

Chen Jinliang 

申请注册联系人电话：

Applicant telephone：

 +86 152 2332 4712

研究负责人电话：

Study leader's
telephone：

+86 135 8848 2447

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：

 xiejiaojiao@cms.net.cn

研究负责人电子邮件：

Study leader's E-mail：

 kingbright10@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：

海南省海口市国家高新技术产业开发区科技大道22号海口国科中心C座6楼

研究负责人通讯地址：

浙江省杭州市萧山区育才北路 728 号

Applicant address：

6th Floor, Building C, Haikou Guoke Center, 22 Keji Avenue, National High-tech Industrial Development Zone, Haikou, Hainan

Study leader's address：

No. 728, Yucai North Road, Xiaoshan District, Hangzhou, Zhejiang

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：

海南德镁医药科技有限责任公司

Applicant's institution：

Hainan Demei Pharmaceutical Technology Co., Ltd

研究负责人所在单位：

浙江萧山医院

Affiliation of the Leader：

Zhejiang Xiaoshan 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：

 EC-2025092310

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：

浙江萧山医院药物临床试验伦理委员会

Name of the ethic committee：

Ethics Committee for Drug Clinical Trials, Xiaoshan Hospital, Zhejiang

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-09-23 00:00:00

伦理委员会联系人：

陈青莲

Contact Name of the ethic committee：

Chen Qinglian

伦理委员会联系地址：

浙江省杭州市萧山区育才北路 728 号

Contact Address of the ethic committee：

No. 728, Yucai North Road, Xiaoshan District, Hangzhou, Zhejiang

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 571 8220 1925

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 zjxshec@163.com

研究实施负责（组长）单位：

浙江萧山医院

Primary sponsor：

Zhejiang Xiaoshan Hospital

研究实施负责（组长）单位地址：

浙江省杭州市萧山区育才北路 728 号

Primary sponsor's address：

No. 728, Yucai North Road, Xiaoshan District, Hangzhou, Zhejiang

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

海南

市(区县)：

Country：

China

Province：

Hai'nan

City：

单位(医院)：

海南德镁医药科技有限责任公司

具体地址：

海南省海口市国家高新技术产业开发区科技大道22号海口国科中心C座6楼整层

Institution
hospital：

Hainan Dermavon Pharmaceutical Technology Co., Ltd.

Address：

6th Floor, Block C, Haikou National Science and Technology Center, No. 22 Science and Technology Avenue, National High tech Industrial Development Zone, Haikou City, Hainan Province

经费或物资来源：

海南德镁医药科技有限责任公司

Source(s) of funding：

Hainan Dermavon Pharmaceutical Technology Co., Ltd.

研究疾病：

无  

Target disease：

None

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：

主要目的：初步评估中国健康成人研究参与者空腹下单剂量口服磷酸泊沃昔替尼片两个制剂（30mg）的生物等效性  

Objectives of Study：

Primary objective: To preliminarily evaluate the bioequivalence of two formulations (30mg) of Powdered Poxatinib Phosphate Tablets administered orally in a single dose to healthy adult study participants in China on an empty stomach

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)自愿参加本试验，并签署知情同意书，能够和研究者进行良好的沟通，并且理解和遵守本试验的各项要求和限制条件； 2)年龄18周岁及以上，男性和女性； 3)男性体重≥50.0 kg，女性体重≥45.0 kg；体重指数在18.0~27.0 kg/m2（包括边界值）； 4)自签署知情同意书至试验末次给药后3个月内无怀孕或捐精、捐卵计划，且此期间必须遵守避孕的相关规定，必须同意采取至少一种高效或可接受的非激素避孕方法，或男性伴侣已在筛选访视前至少6个月行绝育手术等。

Inclusion criteria

1.Voluntary participation in this trial, signing an informed consent form, the ability to communicate effectively with the researchers, and understanding and complying with all the requirements and restrictions of this trial. 2.Age 18 and above, both male and female. 3.Male body weight>=50.0 kg, female body weight >=45.0 kg; body mass index within 18.0~27.0 kg/m2 (inclusive of boundary values).. 4.Within 3 months from the signing of the informed consent form until the last administration of the trial, if there is no pregnancy or plan to donate sperm or eggs, and during this period, relevant contraception regulations must be followed, and at least one efficient or acceptable non hormonal contraceptive method must be agreed upon, or if the male partner has undergone sterilization surgery at least 6 months before the screening visit.

排除标准：

1)已知有过敏史，或对本试验药物的任何成份有变态反应、超敏反应、不耐受或禁忌症者； 2)既往或目前有慢性或活动性消化道疾病，如食管疾病、胃食管反流、胃肠道穿孔、胃肠道瘘、胃炎、胃肠道溃疡、吸收不良综合征、炎症性肠病、部分性或完全性肠梗阻、乳糜泻、肠炎、胰腺炎，活动性胃肠道出血或进行过消化道手术如胃束带/胃切除术、胆囊切除术、肠切除术（阑尾切除术除外），且研究者认为目前仍有临床意义者；或试验药物给药前7天内有消化道症状，且研究者认为不宜参加本试验者； 3)有心血管、脑血管、外周血管或血栓性疾病或未控制的高血压病史者（筛选时收缩压> 140 mmHg，或舒张压> 90 mmHg，且经重复检测确认）; 4)患有任何增加出血性风险的疾病者，如急性胃炎或活动性溃疡伴出血、具有临床意义的血小板减少或贫血，以及有活动性病理性出血或有颅内出血病史者； 5)筛选前5年内有恶性肿瘤病史者，皮肤基底细胞癌或鳞状细胞癌治愈者除外； 6)筛选前6个月内有临床表现异常需排除的其他疾病，包括但不限于，循环系统、内分泌系统、神经系统、呼吸系统、泌尿系统、血液学、免疫学、精神病学、代谢和骨骼的异常，以及需要全身性抗生素、抗真菌或抗病毒治疗的慢性或活动性感染性疾病（包括潜伏期治疗的结核病）； 7)试验药物给药前3个月内接受过手术包括影响药物吸收、分布、代谢和排泄的手术，或计划在试验期间进行手术者； 8)酗酒者，或试验药物给药前6个月内经常饮酒，即每周饮酒超过14单位酒精，或本次试验入组前酒精呼气检查结果大于0.0 mg/100mL者；或拒绝整个试验期间停止饮酒或停止摄入任何含酒精制品者； 9)滥用药物者，或试验药物给药前3个月内使用过软毒品（如：大麻）或试验药物给药前1年内使用过硬毒品（如：可卡因、苯环己哌啶等）者，或本次试验入组前尿药筛查阳性者； 10)嗜烟者；或试验药物给药前3个月内每日吸烟量多于4支者，或试验期间不能停止使用任何烟草类产品（包括电子烟）者； 11)试验药物给药前3个月内每天饮用过量（8杯以上，1杯=250 mL）茶、咖啡或含咖啡因的饮料者； 12)试验药物给药前1个月内接种过疫苗，或计划在试验期间接种疫苗者； 13)试验药物给药前1个月内使用过口服避孕药者，或试验药物给药前6个月内使用过长效雌激素或孕激素注射剂或埋植剂者；或现有性激素埋植剂者； 14)当前治疗或在试验药物给药前15天或5个半衰期内使用过其他任何药物或保健品（含中草药）者，包括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、苯妥英钠、利福平等；抑制剂-SSRI类抗抑郁药、西咪替丁、环孢素、大环内酯类、维拉帕米、喹诺酮类、镇静催眠药、吡咯类抗真菌药、HIV蛋白酶抑制剂等），以及影响转运体P-gp和BCRP活性的药物（如，雷诺嗪、维拉帕米、伊曲康唑、克拉霉素、利托那韦和姜黄素、环孢素A等）; 15)体格检查、生命体征检查、胸部正位片、12-导联心电图及实验室检查异常且经临床医师或研究者判断有临床意义不宜参加本试验者； 16)乙型肝炎表面抗原、血清梅毒螺旋体特异性抗体，抗人类免疫缺陷病毒（HIV）抗体，或丙型肝炎病毒（HCV）抗体检查结果，任一项为阳性者； 17)试验前有特殊饮食和/或运动因素可能影响试验期间药物吸收、分布、代谢、排泄者，包括但不限于：试验药物给药前7天内摄入过有可能影响药物代谢的特殊饮食（包括火龙果、芒果、柚子[葡萄柚]、圣·约翰草[贯叶连翘]、橙子、柑橘、杨桃、木瓜、石榴或由其制备的食物或饮料者，或入住前72小时内，摄入过含咖啡因（如咖啡、浓茶、巧克力等）或富含黄嘌呤成分（如，动物内脏、海鲜、浓肉汤或肉汁等）的食物或饮料者，或入住前72小时内有剧烈运动等；或拒绝在整个试验期间避免具有此类饮食或行为者； 18)试验药物给药前3个月内献过血或失血≥400 mL，或4个月内接受过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； 19)试验药物给药前3个月内使用了任何其他临床试验药物或入组了任何其他药物临床试验者； 20)女性在试验药物给药前14天内有过无保护性行为者，或妊娠期或哺乳期女性； 21)不能忍受静脉穿刺和/或有晕血、晕针史者； 22)对饮食有特殊要求，不能遵守统一饮食或吞咽困难者； 23)乳糖、半乳糖或果糖不耐受、葡萄糖-半乳糖吸收不良、蔗糖酶-异麦芽糖酶不足或全乳糖酶缺乏症等罕见遗传性问题者（曾发生过喝牛奶腹泻者）； 24)依从性差或可能因为其他原因不能完成本试验，或研究者判断不适宜参加本试验者。

Exclusion criteria：

1.Individuals with a known history of allergies, or those who have allergic reactions, hypersensitivity reactions, intolerance, or contraindications to any component of the investigational drug. 2.Those who have had or currently have chronic or active gastrointestinal diseases, such as esophageal disease, gastroesophageal reflux, gastrointestinal perforation, gastrointestinal fistula, gastritis, gastrointestinal ulcer, malabsorption syndrome, inflammatory bowel disease, partial or complete intestinal obstruction, celiac disease, enteritis, pancreatitis, active gastrointestinal bleeding, or have undergone gastrointestinal surgeries such as gastric banding/gastrectomy, cholecystectomy, and intestinal resection (excluding appendectomy), and researchers believe that they still have clinical significance at present; Those who have digestive symptoms within 7 days before the administration of the investigational drug and are deemed unsuitable by the researcher to participate in this trial. 3.Individuals with a history of cardiovascular, cerebrovascular, peripheral vascular or thrombotic diseases or uncontrolled hypertension (systolic blood pressure>140 mmHg or diastolic blood pressure>90 mmHg at screening, confirmed by repeated testing).. 4.Individuals with any disease that increases the risk of bleeding, such as acute gastritis or active ulcers with bleeding, clinically significant thrombocytopenia or anemia, as well as those with active pathological bleeding or a history of intracranial hemorrhage. 5.Individuals with a history of malignant tumors within the past 5 years, excluding those cured of basal cell carcinoma or squamous cell carcinoma of the skin. 6.Other diseases with abnormal clinical manifestations that need to be excluded within 6 months before screening, including but not limited to circulatory system, endocrine system, nervous system, respiratory system, urinary system, hematology, immunology, psychiatry, metabolic and skeletal abnormalities, as well as chronic or active infectious diseases requiring systemic antibiotics, antifungal or antiviral treatment (including tuberculosis with latent treatment).. 7.Those who have undergone surgery within 3 months prior to administering the investigational drug, including surgeries that affect drug absorption, distribution, metabolism, and excretion, or those who plan to undergo surgery during the trial period. 8.Alcoholics, or those who frequently drink alcohol within 6 months before the administration of the investigational drug, that is, more than 14 units of alcohol [1 unit ≈ 360 mL beer or 45 mL Baijiu or 150 mL wine with 40% alcohol] every week, or those whose alcohol breath test results are greater than 0.0 mg/100mL before enrollment in this trial; Or refuse to stop drinking alcohol or consuming any alcoholic products throughout the entire trial period. 9.Individuals who abuse drugs, or have used soft drugs (such as marijuana) within the past 3 months before administering the experimental drug, or have used hard drugs (such as cocaine, phencyclidine, etc.) within the past 1 year before administering the experimental drug, or have tested positive for urinary drug screening before enrollment in this trial. 10.Smokers; Those who smoke more than 4 cigarettes per day within 3 months before administering the investigational drug, or those who cannot stop using any tobacco products (including electronic cigarettes) during the trial period. 11.Individuals who have consumed excessive amounts (8 or more cups, 1 cup=250 mL) of tea, coffee, or caffeinated beverages daily within 3 months prior to administering the investigational drug. 12.Individuals who have received the vaccine within one month prior to administering the investigational drug, or who plan to receive the vaccine during the trial period. 13.Those who have used oral contraceptives within one month before administering the experimental drug, or those who have used long-acting estrogen or progesterone injections or implants within six months before administering the experimental drug; Or those who currently have sex hormone implants. 14.Current treatment or use of any other medication or health supplement (including traditional Chinese medicine) within 15 days or 5 half lives (whichever is longer) before the administration of the investigational drug, including any medication that inhibits or induces liver drug metabolism enzymes (such as inducers barbiturates, carbamazepine, phenytoin sodium, rifampicin; inhibitors SSRI antidepressants, cimetidine, cyclosporine, macrolides, verapamil, quinolone, sedative hypnotic drugs, pyrrole antifungal drugs, HIV protease inhibitors, etc.), as well as drugs that affect the activity of transporter P-gp and BCRP (such as ranazine, verapamil, itraconazole, clarithromycin, etc.) Ritonavir, curcumin, cyclosporine A, etc. 15.Individuals who have undergone physical examination, vital sign examination, chest radiograph, 12 lead electrocardiogram, and laboratory tests, and are deemed clinically significant by clinical physicians or researchers, are not suitable to participate in this trial. 16.Individuals who test positive for either hepatitis B surface antigen, serum Treponema pallidum specific antibody, anti human immunodeficiency virus (HIV) antibody, or hepatitis C virus (HCV) antibody. 17.Individuals who have special dietary and/or exercise factors prior to the trial that may affect drug absorption, distribution, metabolism, and excretion during the trial period, including but not limited to: those who have consumed special diets (including dragon fruit, mango, grapefruit, St. John's wort, orange, citrus, starfruit, papaya, pomegranate, or foods or beverages prepared from them) that may affect drug metabolism within 7 days prior to the administration of the trial drug, or those who have consumed foods or beverages containing caffeine (such as coffee, strong tea, chocolate, etc.) or foods or beverages rich in xanthine components (such as animal organs, seafood, thick meat soup, or meat juice, etc.) within 72 hours prior to check-in, or those who have engaged in vigorous exercise within 72 hours prior to check-in; The sentence is:; Or refuse to avoid such diets or behaviors throughout the entire trial period. 18.Individuals who have donated blood or lost ≥ 400 mL within 3 months prior to administering the investigational drug, or who have received blood transfusions or used blood products within 4 months, or who intend to donate blood (including blood components) during or within 3 months after the end of the trial. 19.Within 3 months prior to the administration of the investigational drug, any other clinical trial drug was used or any other drug clinical trial participant was enrolled. 20.Women who have had unprotected sex within 14 days prior to the administration of the investigational drug, or women who are pregnant or breastfeeding. 21.Those who cannot tolerate venipuncture and/or have a history of dizziness or needle sickness. 22.Individuals with special dietary requirements who cannot adhere to a uniform diet or have difficulty swallowing. 23.Individuals with rare genetic problems such as lactose, galactose, or fructose intolerance, glucose galactose malabsorption, insufficient sucrase isomaltase, or lactase deficiency (those who have experienced milk diarrhea).. 24.Poor compliance or possible inability to complete this trial for other reasons, or the researcher's judgment that participants are not suitable to participate in this trial

研究实施时间：

Study execute time：

从 From 2025-11-01 00:00:00至 To 2026-02-28 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-11-10 00:00:00 至 To 2025-11-20 00:00:00

干预措施：

Interventions：

组别：

T-R组

样本量：

 6

Group：

T-R group

Sample size：

干预措施：

第一周期：T制剂，第二周期：R制剂

干预措施代码：

Intervention：

First Period: Formulation T, Second Period: Formulation R

Intervention code：

组别：

R-T组

样本量：

 6

Group：

R-T group

Sample size：

干预措施：

第一周期：R制剂，第二周期：T制剂

干预措施代码：

Intervention：

First Period: Formulation R, Second Period: Formulation T

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)：

 浙江萧山医院 

单位级别：

 三级 

Institution
hospital：

Zhejiang Xiaoshan Hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

药代动力学

指标类型：

主要指标

Outcome：

Pharmacokinetic

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

安全性评价

指标类型：

次要指标

Outcome：

Safety evaluation

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 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）：

本研究为单中心、随机、开放、两序列、两周期、自身交叉设计。12名研究参与者按1:1的比例被随机分配至2个给药顺序组。随机分配表由生物统计人员采用随机数字表法产生。

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

This study was a single-center, randomized, open-label, two-sequence, two-period, and self-crossover design. Twelve study participants were randomly assigned to two drug administration sequence groups in a 1:1 ratio. The random allocation table was generated by biostatisticians using a random number table method.

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：

本研究设计为开放性试验，生物样本将采用盲态分析，在样本分析过程中，分析人员不知道研究参与者每周期的给药分配。除生物样本分析人员外，其他人员如临床研究者、研究参与者、项目管理人员、项目监查人员、数据管理及数据分析人员等均不设盲。

Blinding：

This study is designed as an open-label trial, and the biological samples will undergo blinded analysis. During the sample analysis process, the analysts are unaware of the drug allocation for each period of the study participants. Except for the biological sample analysts, other personnel such as clinical researchers, study participants, project managers, project monitors, data management, and data analysis personnel are not blinded.

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

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：

电子采集和管理系统

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

Electronic Data Capture, EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-11-10 17:13:45