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：	ChiCTR2400094889
最近更新日期： Date of Last Refreshed on：	2025-10-17 15:15:04
注册时间： Date of Registration：	2024-12-30 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	德度司他片在中国健康成年受试者中的生物等效性研究
Public title：	Bioequivalence Study of Desidustat Tablets in Healthy Adult Subjects in China
注册题目简写：
English Acronym：
研究课题的正式科学名称：	德度司他片在中国健康成年受试者中的生物等效性研究
Scientific title：	Bioequivalence Study of Desidustat Tablets in Healthy Adult Subjects in China
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：	龙岗祥	研究负责人：	李伟
Applicant：	Long Gangxiang	Study leader：	Li Wei
申请注册联系人电话： Applicant telephone：	+86 151 1563 7272	研究负责人电话： Study leader's telephone：	+86 139 7368 2788
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：	longgangxiang-hncms@cms.net.cn	研究负责人电子邮件： Study leader's E-mail：	491864244@qq.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：	湖南省常德市澧县临江西路7号	研究负责人通讯地址：	湖南省益阳市赫山区康富北路118号
Applicant address：	7 Linjiang Road West, Li County, Changde, Hunan	Study leader's address：	No. 118, Kangfu North Road, Heshan District, Yiyang City, Hunan 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：	康哲(湖南)制药有限公司
Applicant's institution：	Kangzhe (Hunan) Pharmaceutical Co., Ltd.
研究负责人所在单位：	益阳市中心医院
Affiliation of the Leader：	Yiyang Central 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：	快审2024年[077]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：	益阳市中心医院临床试验伦理委员会
Name of the ethic committee：	Ethics Committee for Clinical Trials, Yiyang Central Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2024-12-11 00:00:00
伦理委员会联系人：	艾霜
Contact Name of the ethic committee：	Ai Shuang
伦理委员会联系地址：	益阳市赫山区康富北路118号
Contact Address of the ethic committee：	No. 118, Kangfu North Road, Heshan District, Yiyang City, Hunan Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 737 420 2083	伦理委员会联系人邮箱： Contact email of the ethic committee：	yyzxyygcpll@163.com

研究实施负责（组长）单位：

益阳市中心医院

Primary sponsor：

Yiyang Central Hospital

研究实施负责（组长）单位地址：

湖南省益阳市赫山区康富北路118号

Primary sponsor's address：

No. 118, Kangfu North Road, Heshan District, Yiyang City, Hunan 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)：	湖南	市(区县)：
Country：	China	Province：	Hunan	City：
单位(医院)：	康哲（湖南）制药有限公司	具体地址：	湖南省常德市澧县临江西路7号
Institution hospital：	Kangzhe (Hunan) Pharmaceutical Co., Ltd.	Address：	7 Linjiang Road West, Li County, Changde, Hunan

经费或物资来源：

申办方

Source(s) of funding：

Sponsor

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：

I期临床试验

Study phase：

1

研究设计：

随机交叉对照

Study design：

Cross-over

研究目的：

考察健康受试者在空腹条件下，单次口服1片由康哲（湖南）制药有限公司提供的德度司他片【研究制剂A，规格：25mg】与单次口服1片由康哲（湖南）制药有限公司提供的德度司他片【研究制剂B，规格：25mg】的药动学特征，考察两制剂间的生物等效性和安全性

Objectives of Study：

To investigate the pharmacokinetic characteristics of a single oral dose of one tablet of Desidustat Tablets [Test Formulation A, Specification: 25mg] provided by Kangzhe (Hunan) Pharmaceutical Co., Ltd. and a single oral dose of one tablet of Desidustat Tablets [Test Formulation B, Specification: 25mg] also provided by Kangzhe (Hunan) Pharmaceutical Co., Ltd., under fasting conditions in healthy subjects. The study will evaluate the bioequivalence and safety between the two formulations.

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. Informed Consent: Subjects must provide informed consent for the trial after being fully informed about the trial content, procedures, and potential adverse reactions. They must voluntarily sign a written informed consent form prior to participating in the study.
2. Communication and Compliance: Subjects must be able to communicate effectively with the investigators and comply with the protocol requirements throughout the trial.
3. Gender: Both males and females are eligible.
4. Age: Subjects must be 18 years of age or older (inclusive of the boundary value).
5. Weight: Male subjects must weigh >=50 kg; female subjects must weigh >=45 kg. The Body Mass Index (BMI = weight (kg) / height² (m²)) must be within the range of 19.0 to 26.0 kg/m² (inclusive of the boundary values).
6. Contraception Requirements: From the time of signing the informed consent form until 3 months after the last dose of the study medication, subjects must not plan to become pregnant or donate sperm/eggs. During this period, they must agree to use at least one highly effective or acceptable non-hormonal method of contraception

排除标准：

1) 已知有过敏史，或对本试验用药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，如胃肠道穿孔、胃肠道瘘、食管疾病、胃炎、胃肠道溃疡、肠炎、胃食管反流、胰腺炎，活动性胃肠道出血或进行过消化道手术，且研究者认为目前仍有临床意义者；或服用试验用药前7天内有消化道症状（腹泻、便秘、恶心、呕吐、排便不规律，或腹泻便秘交替性发作），且研究者认为不宜参加本研究者； 3) 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、代谢及骨骼异常，或能干扰研究结果的任何其他疾病或家族史（如：肝硬化、结核、高血压、糖尿病（或家族史）、骨质疏松症、青光眼（或家族史）、白内障、感染、水痘、肝功能障碍、肾功能障碍、视觉障碍等）者； 4) 患有任何增加出血性风险的疾病者，如活动性溃疡伴出血、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) 在筛选前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，或计划在研究期间进行手术者； 6) 不能忍受静脉穿刺和/或有晕血、晕针史者； 7) 酗酒者，或服用试验用药前6个月内经常饮酒，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%的白酒或150mL葡萄酒】； 8) 滥用药物者，或服用试验用药前3个月内使用过软毒品（如：大麻）或服用试验用药前1年内使用过毒品（如：可卡因、苯环己哌啶等）者； 9) 嗜烟者；或服用试验用药前3个月内每日吸烟量多于5支者，或研究期间不能停止使用任何烟草类产品者； 10) 服用试验用药前3个月内每天饮用过量茶、咖啡或含咖啡因的饮料（8杯以上，1杯=250mL）者； 11) 对饮食有特殊要求，不能遵守统一饮食或吞咽困难者； 12) 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）； 13) 体格检查、生命体征检查、12导联心电图及实验室检查异常者（经临床医师判断有临床意义不宜参加本研究）； 14) 乙肝表面抗原、丙肝抗体、艾滋病抗体或梅毒抗体检查结果，任一项为阳性者； 15) 服用试验用药前1个月内接种过疫苗，或计划在研究期间接种疫苗者； 16) 服用试验用药前1个月内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），以及转运体OAT3抑制剂（如，对氨基马尿酸、丙磺舒、特立氟胺）者； 17) 服用试验用药前1个月内使用过其他任何药物或保健品（包括处方药、非处方药、中药制剂、功能性维生素和保健品）者； 18) 研究前有特殊饮食和/或运动因素可能影响研究期间药物吸收、分布、代谢、排泄者，包括但不限于：服用试验用药前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）、酸橙、杨桃、木瓜、石榴或由其制备的食物或饮料者； 19) 服用试验用药前3个月内献过血或失血≥400mL，或1个月内接受过输血或使用血制品者，或打算在研究期间或研究结束后3个月内献血（包括血液成份）者； 20) 服用试验用药前3个月内使用了任何其他临床试验用药或入组了任何其他药物临床研究者； 21) 依从性差或可能因为其他原因不能完成本研究，或研究者判断不适宜参加本研究者；女性受试者除上述要求外，符合下列条件的也应排除： 22) 筛选首次给药前30天内使用口服避孕药者； 23) 筛选首次给药前6个月内使用长效雌激素或孕激素注射剂或埋植片者，或现有性激素埋植剂者； 24) 筛选前14天内与伴侣发生无避孕或无保护性措施的性行为者； 25) 血妊娠检查结果异常有临床意义者； 26) 哺乳期者。首次入住排除标准： 27) 入住I期临床研究中心前72h内，吸烟量多于5支者； 28) 入住呼气酒精测试阳性者； 29) 入住尿液药物筛查阳性者； 30) 入住生命体征测量异常有临床意义者； 31) 入住I期临床研究中心前72h内，食用过咖啡因、茶碱、嘌呤的饮料（如咖啡、浓茶、巧克力、可乐等）或食物（如动物内脏、海鲜、浓肉汤或肉汁等），或食用葡萄柚、西柚、火龙果、芒果等可能影响代谢的水果或饮料者，或入住前72h内有剧烈运动等； 32) 筛选至入住当天，发生急性疾病且经研究医生评估不适宜参加研究者； 33) 筛选至入住当天，使用过任何药物（包括处方药、非处方药、中药制剂、功能性维生素和保健品）者； 34) 筛选至入住当天，发生过无保护措施性行为者； 35) 筛选至入住当天，因任何原因节食或特殊饮食（如高钾、低钠）者； 36) 女性受试者入住血妊娠检查结果异常有临床意义者。

Exclusion criteria：

1. Known Allergy History: Known history of allergy, hypersensitivity, intolerance, or contraindication to any component of the study medication. 2. Gastrointestinal Disease: Past or current chronic or active gastrointestinal disease (e.g., gastrointestinal perforation, fistula, esophageal disease, gastritis, peptic ulcers, colitis, gastroesophageal reflux, pancreatitis, active gastrointestinal bleeding, or previous gastrointestinal surgery) that the investigator considers clinically significant; or gastrointestinal symptoms within 7 days before dosing (diarrhea, constipation, nausea, vomiting, irregular bowel movements, or alternating diarrhea and constipation) that the investigator deems inappropriate for study participation. 3. Other Clinical Conditions: Presence of other clinically relevant diseases that need exclusion, including but not limited to cardiovascular, endocrine, neurological, respiratory, urinary, hematological, immunological, psychiatric, metabolic, or skeletal abnormalities, or any other condition or family history that could interfere with study outcomes (e.g., cirrhosis, tuberculosis, hypertension, diabetes [or family history], osteoporosis, glaucoma [or family history], cataracts, infections, chickenpox, liver dysfunction, renal impairment, visual disorders). 4. Increased Bleeding Risk: Any condition that increases bleeding risk, such as active ulcer with bleeding, clinically significant thrombocytopenia or anemia, active pathological bleeding, or history of intracranial hemorrhage. 5. Recent Surgery: Surgery within 3 months prior to screening, including surgeries affecting drug absorption, distribution, metabolism, or excretion, or planned surgery during the study period. 6. Inability to Tolerate Venipuncture: Inability to tolerate venipuncture or history of fainting due to blood or needle exposure. 7. Alcohol Abuse: History of alcoholism or regular alcohol consumption exceeding 14 units per week (1 unit ~ 360 mL beer, 45 mL 40% alcohol by volume spirits, or 150 mL wine) within 6 months before dosing. 8. Drug Abuse: History of substance abuse, including use of soft drugs (e.g., marijuana) within 3 months before dosing or hard drugs (e.g., cocaine, phencyclidine) within 1 year before dosing. 9. Smoking Habit: Smokers who have smoked more than 5 cigarettes daily within 3 months before dosing or cannot stop using tobacco products during the study. 10. Excessive Caffeine Consumption: Consumption of excessive tea, coffee, or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) within 3 months before dosing. 11. Special Dietary Requirements: Special dietary requirements that prevent adherence to a standardized diet or difficulty swallowing. 12. Carbohydrate Intolerance: Lactose, galactose, or fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase deficiency, or complete lactase deficiency (history of diarrhea after drinking milk). 13. Physical Examination Abnormalities: Abnormal findings in physical examination, vital signs, 12-lead ECG, or laboratory tests deemed clinically significant by a physician. 14. Infectious Diseases: Positive test results for hepatitis B surface antigen, hepatitis C antibodies, HIV antibodies, or syphilis antibodies. 15. Vaccination: Vaccination within 1 month before dosing or planned vaccination during the study period. 16. Liver Enzyme Modulators: Use of medications that inhibit or induce hepatic drug-metabolizing enzymes within 1 month before dosing (e.g., inducers-barbiturates, carbamazepine, phenytoin, rifampicin; inhibitors-SSRIs, cimetidine, cyclosporine, macrolides, verapamil, quinolones, sedative hypnotics, azole antifungals, HIV protease inhibitors) and OAT3 inhibitors (e.g., para-aminohippuric acid, probenecid, teriflunomide). 17. Other Medications or Supplements: Use of any other medications or supplements (including prescription, over-the-counter, traditional Chinese medicine, functional vitamins, and health supplements) within 1 month before dosing. 18. Dietary and Exercise Factors: Special dietary habits or exercise factors that may affect drug absorption, distribution, metabolism, or excretion, including consumption of foods or beverages known to influence drug metabolism (e.g., dragon fruit, mango, grapefruit, St. John's Wort, lime, starfruit, papaya, pomegranate) within 7 days before dosing. 19. Blood Donation or Loss: Blood donation or loss >=400 mL within 3 months before dosing, transfusion or use of blood products within 1 month before dosing, or plans to donate blood (including components) within 3 months after the study ends. 20. Other Clinical Trials: Participation in another clinical trial or use of investigational drugs within 3 months before dosing. 21. Poor Compliance: Poor compliance or inability to complete the study for any other reason as determined by the investigator. Additional Exclusion Criteria for Female Subjects: 22. Oral Contraceptives: Use of oral contraceptives within 30 days before first dosing. 23. Hormonal Contraception: Use of long-acting estrogen or progesterone injections or implants within 6 months before first dosing, or existing hormonal implants. 24. Unprotected Sexual Activity: Unprotected sexual activity within 14 days before screening. 25. Pregnancy Test: Clinically significant abnormal pregnancy test result. 26. Breastfeeding: Currently breastfeeding. Exclusion Criteria for Initial Admission: 27. Smoking: Smoking more than 5 cigarettes within 72 hours before admission. 28. Alcohol Breath Test: Positive breath alcohol test upon admission. 29. Drug Screening: Positive urine drug screen upon admission. 30. Vital Signs Abnormality: Clinically significant abnormal vital signs upon admission. 31. Caffeine, Theophylline, Purine Consumption: Consumption of caffeine, theophylline, purine-containing beverages (e.g., coffee, strong tea, chocolate, cola) or foods (e.g., animal organs, seafood, strong meat broth or juice), or fruits/beverages that can affect metabolism (e.g., grapefruit, pomelo, dragon fruit, mango) within 72 hours before admission, or vigorous exercise. 32. Acute Illness: Acute illness from screening to admission day that the study doctor deems unsuitable for participation. 33. Medication Use: Use of any medications (including prescription, over-the-counter, traditional Chinese medicine, functional vitamins, and health supplements) from screening to admission day. 34. Unprotected Sexual Activity: Unprotected sexual activity from screening to admission day. 35. Dietary Restrictions: Fasting or special diets (e.g., high potassium, low sodium) from screening to admission day. 36. Pregnancy Test: Clinically significant abnormal pregnancy test result for female subjects upon admission.

研究实施时间：

Study execute time：

从 From 2024-12-27 00:00:00至 To 2025-12-26 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-12-30 00:00:00 至 To 2025-01-03 00:00:00

干预措施：

Interventions：

组别：	A-B组	样本量：	12
Group：	A-B group	Sample size：	12
干预措施：	第一周期：A制剂，第二周期：B制剂	干预措施代码：
Intervention：	First Period: Formulation A, Second Period: Formulation B	Intervention code：

组别：	B-A组	样本量：	12
Group：	B-A group	Sample size：	12
干预措施：	第一周期：B制剂，第二周期：A制剂	干预措施代码：
Intervention：	First Period: Formulation B, Second Period: Formulation A	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	湖南省	市(区县)：
Country：	China	Province：	Hunan	City：
单位(医院)：	益阳市中心医院	单位级别：	三甲
Institution hospital：	Yiyang Central Hospital	Level of the institution：	Tertiary A

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：	主要指标
Outcome：	Safety evaluation	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：

结束

/Completed

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）：

随机数字表

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

Random number table

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：	无
Blinding：	none
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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：	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：	2024-12-30 14:33:28