ChiCTR2500109091 版本V1.0 版本创建时间2025/09/11 15:48:07 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：

 ChiCTR2500109091 

最近更新日期：

Date of Last Refreshed on：

 2025-09-11 15:47:25 

注册时间：

Date of Registration：

 2025-09-11 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

瑞舒伐他汀钙片的人体生物等效性研究

Public title：

Rosuvastatin Calcium Tablets Human Bioequivalence Study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

瑞舒伐他汀钙片在中国健康受试者中的单次给药、随机、开放、两制剂、两序列、两周期、双交叉、空腹和餐后状态下的生物等效性试验

Scientific title：

A Single-Dose, Randomized, Open-Label, Two-Preparation, Two-Sequence, Two-Period, Crossover Bioequivalence Study of Rosuvastatin Calcium Tablets in Chinese Healthy Subjects Under Fasting and Fed Conditions

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：

沈珍 

研究负责人：

樊莲莲/韩杨云 

Applicant：

Zhen Shen 

Study leader：

Fan Lianlian/Han Yunyun 

申请注册联系人电话：

Applicant telephone：

 +86 838 241 8213

研究负责人电话：

Study leader's
telephone：

+86 838 2312773

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：

 941201850@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 510791761@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：

四川省德阳市旌阳区泰山北路173号

研究负责人通讯地址：

四川省德阳市旌阳区泰山北路一段173号

Applicant address：

173 Taishan Road North, Jingyang District, Deyang, Sichuan, China

Study leader's address：

173, 1st Section, North Taishan Road, Jingyang District, Deyang City, Sichuan 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：

德阳市人民医院

Applicant's institution：

Deyang People's Hospital

研究负责人所在单位：

德阳市人民医院

Affiliation of the Leader：

People's Hospital of Deyang City

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：

 2025-01-067-K01

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：

德阳市人民医院临床试验伦理委员会

Name of the ethic committee：

Clinical trial Ethics Committee of Deyang People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-08-20 00:00:00

伦理委员会联系人：

肖雪

Contact Name of the ethic committee：

Xiao Xue

伦理委员会联系地址：

四川省德阳市旌阳区泰山北路一段173号

Contact Address of the ethic committee：

173, 1st Section, North Taishan Road, Jingyang District, Deyang City, Sichuan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 838 2312773

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 891627253@qq.com

研究实施负责（组长）单位：

德阳市人民医院

Primary sponsor：

People's Hospital of Deyang City

研究实施负责（组长）单位地址：

四川省德阳市旌阳区泰山北路一段173号

Primary sponsor's address：

173, 1st Section, North Taishan Road, Jingyang District, Deyang City, Sichuan 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)：

四川省

市(区县)：

Country：

China

Province：

Sichuan

City：

单位(医院)：

德阳市人民医院

具体地址：

四川省德阳市旌阳区泰山北路一段173号

Institution
hospital：

People's Hospital of Deyang City

Address：

173, 1st Section, North Taishan Road, Jingyang District, Deyang City, Sichuan Province

经费或物资来源：

浙江诺得药业有限公司

Source(s) of funding：

Zhejiang NuoDe Pharmaceutical Co., Ltd.

研究疾病：

高脂蛋白血症  

Target disease：

hyperlipoproteinemia

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:以 AstazenecaUKLimited 持证的瑞舒伐他汀钙片为参比制剂，以浙江诺得药业有限公司研发的瑞舒伐他汀钙片为受试制剂，通过单中心随机、开放、单次给药、两周期、两序列、双交叉临床研究来评价两种制剂在空腹和餐后状态下的人体生物等效性。 次要研究目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。  

Objectives of Study：

Main research objective: To evaluate the human bioequivalence of the test formulation (rosuvastatin calcium tablets developed by Zhejiang Nuode Pharmaceutical Co., Ltd.) and the reference formulation (rosuvastatin calcium tablets licensed by AstraZeneca UK Limited) under fasting and fed conditions through a single-center, randomized, open-label, single-dose, two-period, two-sequence, crossover clinical study. Secondary research objective: To observe the safety of the test formulation and the reference formulation in Chinese 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. 年龄≥18周岁且≤65 周岁(包含18和65周岁)的中国男性或女性受试者,男女比例适当:；
2.体重:男性>50 kg,女性≥45 kg，且体重指数(BMI)在 19.0~26.0 kghm2[包含边界值，体重指数=体重(kg)/身高2(m2)]:；
3.筛选时受试者的生命体征、体格检查、实验室检查、12 导联心电图以及胸部X片等检查结果正常或异常经研究者判定为无临床意义者:；
4.既往或现在无下列疾病或病史，或有下列疾病或病史但经研究者判断无临床意义者，包括但不限于心血管系统、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:特别是患有胃肠功能障碍、消化性溃疡、胃肠手术等有影响药物吸收、分布、代谢和排泄的疾病的受试者。
5.受试者从签署知情同意书开始至末次给药后3个月内无妊娠计划且自愿采取非药物性有效避孕措施，避免受试者或其配偶怀孕且无捐精、捐卵计划:；
6.受试者理解并遵守研究流程，自愿参加，并签署知情同意书。

Inclusion criteria

1.Chinese male or female subjects aged >=18 years and <=65 years (inclusive), with an appropriate male-to-female ratio; 2.Body weight: male >50 kg, female >=45 kg, and body mass index (BMI) between 19.0 and 26.0 kg/m^2 (inclusive, BMI = weight (kg)/height2 (m^2)); 3.At screening, the subject's vital signs, physical examination, laboratory tests, 12-lead electrocardiogram, and chest X-ray results are normal or abnormal but judged by the investigator as clinically insignificant; 4.Subjects have no history or current evidence of the following diseases or conditions, or if present, are judged by the investigator as clinically insignificant, including but not limited to cardiovascular, digestive, urogenital, respiratory, hematological, endocrine, immune, neuropsychiatric, musculoskeletal systems, etc. particularly subjects with gastrointestinal dysfunction, peptic ulcers, gastrointestinal surgery, or other diseases that may affect drug absorption, distribution, metabolism, and excretion; 5.Subjects have no pregnancy plans from the signing of the informed consent form until 3 months after the last dose and voluntarily adopt effective non-pharmacological contraceptive measures to prevent pregnancy of the subject or their spouse, with no plans for sperm or egg donation; 6.Subjects understand and comply with the study procedures, voluntarily participate, and sign the informed consent form.

排除标准：

1.有肌病、肌痛、肌肉以及肌腱损伤病史或肌病/横纹肌溶解症等易忠因素(如:本人或家族史中有遗传性肌肉疾病、服药后曾发生过肌毒性)者:；
2.有肝病史或活动性肝病，包括原因不明的血清转氨酶持续升高和任何血清转氨酶升高超过正常值上限(ULN)50%者肌酐超过正常值上限10%者:；
3.筛选前3个月内接受过手术，或者在本研究期间及试验结束后2周内有手术计划者，或者凡接受过会影响药物吸收、分布、代谢、排泄手术的受试者:；
4.存在研究者判定为有临床意义的食物、药物过敏史:或已知对瑞舒伐他汀钙片及其辅料过敏者:或其他变态反应性疾病史(、麻疹、湿疹性皮炎).
5.人类免疫缺陷病毒(HIV)抗体、乙肝表面抗原(HBSAg)、丙肝病毒(HCV)抗体或梅毒螺旋体抗体(TP-Ab)任一项检查结果为阳性者:；
6.筛选前 12 个月内有药物滥用史或者筛选期尿药滥用筛查阳性者:；
7.筛选前6个月内经常饮酒者，即平均每周饮酒超过14单位酒精(1单位≈285 ml, 酒精含量为 3.5%的啤酒或 25 ml 酒精含量为 40%的烈酒或 85ml 酒精含量为12%的葡萄酒)，或者给药前48h直至研究结束不能放弃饮酒者，或者鍗选期酒精呼气测试大于 0.0 mg/100 ml 者:；
8.筛选前3个月平均每日吸烟超过5支(含5支)或者给药前48h直至研究结束不能放弃吸烟者:；
9.筛选前3个月内接受输血或使用血制品或其他原因导致失血>400mL者(女性生理性失血除外):；
10.筛选前3个月内参加过其它临床试验的受试者，或非本人来参加临床试验者:；
11.筛选前2周内使用过任何处方药(含疫苗)、非处方药、中药或保健品的受试者:；
12.筛选前3个月内接种过疫苗，或计划在试验期间接种疫苗者:；
13.试验首次给药前 48 小时食用富含黄嘌呤的饮料(咖啡、茶)或食物(动物肝脏)，或食用巧克力、葡萄柚、柚子、芒果可能影响代谢的水果或果汁者:；
14.对饮食有特殊要求者、不能遵守提供的饮食和相应的规定者:乳糖及半乳糖不耐受者:；
15.处于妊娠期或哺乳期:筛选前 14 天内发生过无保护性行为的女性受试者:血妊娠检查阳性者:；
16.对片剂吞咽困难的受试者:；
17.不能耐受静脉穿刺/留置针采血或有晕针、晕血史者:；
18.研究者认为不适合参加该研究的其他受试者。
19.受试者自愿退出。

Exclusion criteria：

1.Subjects with a history of myopathy, myalgia, muscle or tendon injuries, or predisposing factors for myopathy/rhabdomyolysis (e.g., personal or family history of hereditary muscle disorders, prior drug-induced myotoxicity); 2.Subjects with a history of liver disease or active liver disease, including unexplained persistent elevation of serum transaminases or any elevation of serum transaminases exceeding 50% of the upper limit of normal (ULN) or serum creatinine levels exceeding 10% of the ULN; 3.Subjects who have undergone surgery within 3 months prior to screening, plan to undergo surgery during the study or within 2 weeks after study completion, or have a history of surgery that may affect drug absorption, distribution, metabolism, or excretion; 4.Subjects with a history of clinically significant food or drug allergies (as determined by the investigator) known hypersensitivity to rosuvastatin calcium tablets or their excipients or other allergic diseases (e.g., asthma, urticaria, eczematous dermatitis); 5.Subjects with positive test results for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or Treponema pallidum antibody (TP-Ab); 6. Subjects with a history of drug abuse within 12 months prior to screening or positive urine drug screen during screening; 7. Subjects who regularly consumed alcohol within 6 months prior to screening (averaging >14 units of alcohol per week 1 unit ≈ 285 mL of beer with 3.5% alcohol, 25 mL of spirits with 40% alcohol, or 85 mL of wine with 12% alcohol), or unable to abstain from alcohol from 48 hours prior to dosing until study completion, or with alcohol breath test results >0.0 mg/100 mL during screening; 8. Subjects who smoked an average of >5 cigarettes per day within 3 months prior to screening or unable to abstain from smoking from 48 hours prior to dosing until study completion; 9.Subjects who received blood transfusions or blood products within 3 months prior to screening or experienced blood loss >400 mL for other reasons (excluding physiological blood loss in females); 10. Subjects who participated in other clinical trials within 3 months prior to screening or did not participate in the trial personally; 11.Subjects who used any prescription drugs (including vaccines), over-the-counter drugs, traditional Chinese medicines, or health supplements within 2 weeks prior to screening; 12. Subjects who received vaccinations within 3 months prior to screening or plan to receive vaccinations during the trial; 13. Subjects who consumed xanthine-rich beverages (e.g., coffee, tea) or foods (e.g., animal liver), chocolate, grapefruit, pomelo, mango, or other fruits or juices that may affect metabolism within 48 hours prior to the first dose; 14. Subjects with specific dietary requirements, inability to comply with provided diets and related regulations, or lactose/galactose intolerance; 15. Female subjects who are pregnant or breastfeeding; those who have had unprotected sexual intercourse within 14 days prior to screening; those with a positive blood pregnancy test. 16.16. Subjects who have difficulty swallowing tablets; 16. Subjects who have difficulty swallowing tablets; 17.Subjects who cannot tolerate venipuncture/intravenous cannulation for blood collection or have a history of needle or blood phobia; 18.Other subjects deemed by the investigator as unsuitable for participation in the study; 19.Subjects who voluntarily withdraw.

研究实施时间：

Study execute time：

从 From 2025-08-20 00:00:00至 To 2025-11-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-09-20 00:00:00 至 To 2025-09-30 00:00:00

干预措施：

Interventions：

组别：

B组

样本量：

 12

Group：

Group B

Sample size：

干预措施：

空腹状态先服用参比制剂再服用受试制剂,清洗期为7天。

干预措施代码：

Intervention：

Take the reference preparation before taking the test preparation under fasting conditions, the washing period is 7 days.

Intervention code：

组别：

C组

样本量：

 16

Group：

Group C

Sample size：

干预措施：

餐后状态先服用受试制剂再服用参比制剂,清洗期为7天。

干预措施代码：

Intervention：

Take the test preparation before taking the reference preparation under postprandial conditions, the washing period is 7 days.

Intervention code：

组别：

A组

样本量：

 12

Group：

Group A

Sample size：

干预措施：

空腹状态先服用受试制剂再服用参比制剂,清洗期为7天。

干预措施代码：

Intervention：

Take the test preparation before taking the reference preparation under fasting conditions, the washing period is 7 days.

Intervention code：

组别：

D组

样本量：

 16

Group：

Group D

Sample size：

干预措施：

餐后状态先服用参比制剂再服用受试制剂,清洗期为7天。

干预措施代码：

Intervention：

Take the reference preparation before taking the test preparation under postprandial conditions, the washing period is 7 days.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 四川省 

市(区县)：

  

Country：

China

Province：

Sichuan

City：

单位(医院)：

 德阳市人民医院 

单位级别：

 三级甲等 

Institution
hospital：

People's Hospital of Deyang City

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

峰浓度

指标类型：

主要指标

Outcome：

Peak concentration,Cmax

Type：

Primary indicator

测量时间点：

0-72h

测量方法：

本试验拟采用高效液质联用（HPLC-MS/MS）法测定不同时间点血浆中瑞舒伐他汀的血药浓度。

Measure time point of outcome：

0-72h

Measure method：

This trial intends to use high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) to determine the plasma concentration of rosuvastatin at different time points.

指标中文名：

达峰时间

指标类型：

次要指标

Outcome：

Peak time,Tmax

Type：

Secondary indicator

测量时间点：

0-72h

测量方法：

本试验拟采用高效液质联用（HPLC-MS/MS）法测定不同时间点血浆中瑞舒伐他汀的血药浓度。

Measure time point of outcome：

0-72h

Measure method：

This trial intends to use high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) to determine the plasma concentration of rosuvastatin at different time points.

指标中文名：

血药浓度-时间曲线下面积

指标类型：

主要指标

Outcome：

Area under the concentration-time curve of the drug,AUC0-t

Type：

Primary indicator

测量时间点：

0-72h

测量方法：

本试验拟采用高效液质联用（HPLC-MS/MS）法测定不同时间点血浆中瑞舒伐他汀的血药浓度。

Measure time point of outcome：

0-72h

Measure method：

This trial intends to use high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) to determine the plasma concentration of rosuvastatin at different time points.

指标中文名：

不良事件

指标类型：

次要指标

Outcome：

Adverse event

Type：

Secondary indicator

测量时间点：

D1-D11

测量方法：

观察所有受试者在生床研究期间发生的任何不良事件，通过生命体征、体格检查、实验室检查、心电图检查和不良事件进行评估。

Measure time point of outcome：

D1-D11

Measure method：

All subjects were monitored for any adverse events that occured during the cinical study period, with assessments conducted through vital signs, physical examinations, laboratory tests, electrocardiograms, and recording of adverse events.

指标中文名：

推算到无限大时间的血药浓度-时间曲线下面积

指标类型：

主要指标

Outcome：

Area Under the plasma concentration-time Curve from time zero to infinity,AUC0-∞

Type：

Primary indicator

测量时间点：

0-72h

测量方法：

本试验拟采用高效液质联用（HPLC-MS/MS）法测定不同时间点血浆中瑞舒伐他汀的血药浓度。

Measure time point of outcome：

0-72h

Measure method：

This trial intends to use high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) to determine the plasma concentration of rosuvastatin at different time points.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

全血

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 65 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）：

本试验采用区组随机的方法，统计学单位人员在电子计算机上用SAS 9.4或以上版本的PLAN过程产生受试者随机表

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

This trial adopted a block randomization method, where the statistical unit personnel used the PLAN procedure in SAS version 9.4 or above to generate the subject randomization schedule on an electronic computer.

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）：

不共享

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

prviate

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：

  2025-09-11 15:47:25