ChiCTR2500103046 版本V1.0 版本创建时间2025/05/23 09:36:13 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：

 ChiCTR2500103046 

最近更新日期：

Date of Last Refreshed on：

 2025-05-23 09:34:29 

注册时间：

Date of Registration：

 2025-05-23 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

丙酸氟替卡松雾化吸入用混悬液在健康受试者中的单剂量、空腹、随机、开放、两制剂、两周期、两交叉生物等效性研究

Public title：

Single dose, fasting, randomized, open label, two dose, two cycle, two crossover bioequivalence study of fluticasone propionate nebulized inhalation suspension in healthy subjects

注册题目简写：

English Acronym：

研究课题的正式科学名称：

丙酸氟替卡松雾化吸入用混悬液在健康受试者中的单剂量、空腹、随机、开放、两制剂、两周期、两交叉生物等效性研究

Scientific title：

Single dose, fasting, randomized, open label, two dose, two cycle, two crossover bioequivalence study of fluticasone propionate nebulized inhalation suspension in 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：

郭风雪 

研究负责人：

郭风雪 

Applicant：

Guofengxue 

Study leader：

Fengxue GUO 

申请注册联系人电话：

Applicant telephone：

 +86 17731998618

研究负责人电话：

Study leader's
telephone：

+86 319 2279896

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：

 fxguo2023@163.com

研究负责人电子邮件：

Study leader's E-mail：

 fxguo0266@163.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：

河北省邢台市信都区钢铁北路618号

研究负责人通讯地址：

河北省邢台市泉北西大街1628号

Applicant address：

No. 618, Iron and Steel North Road, Xindu District, Xingtai City, Hebei Province

Study leader's address：

No. 618, Gangtie North Road, Xingtai, Hebei

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：

邢台医学高等专科学校第二附属医院

Applicant's institution：

The Second Affiliated Hospital of Xingtai Medical College

研究负责人所在单位：

邢台医学高等专科学校第二附属医院

Affiliation of the Leader：

The Second Affiliated Hospital Of Xingtai Medical College

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：

 XYEYCTEC-HS-200

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：

邢台医学高等专科学校第二附属医院临床试验伦理委员会

Name of the ethic committee：

xingtaiyixuegaodengzhuankexuexiaodierfushuyiyuanlinchuangshiyanlunliweiyuanhui

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-04-16 00:00:00

伦理委员会联系人：

柳振芳

Contact Name of the ethic committee：

Liu ZhenFang

伦理委员会联系地址：

河北省邢台市泉北西大街1628号

Contact Address of the ethic committee：

No. 618, Gangtie North Road, Xingtai, Hebei

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 319 2279916

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 liuzhenfang.1983@163.com

研究实施负责（组长）单位：

邢台医学高等专科学校第二附属医院

Primary sponsor：

The Second Affiliated Hospital Of Xingtai Medical College

研究实施负责（组长）单位地址：

河北省邢台市泉北西大街1628号

Primary sponsor's address：

No. 618, Gangtie North Road, Xingtai, Hebei

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

市(区县)：

Country：

China

Province：

Sichuan

City：

单位(医院)：

四川普锐特药业有限公司

具体地址：

四川省成都高新区安泰五路566号

Institution
hospital：

Sichuan Prite Pharmaceutical Co., Ltd

Address：

No. 566, Antai 5th Road, Chengdu High-tech Zone, Sichuan Province

经费或物资来源：

四川普锐特药业有限公司

Source(s) of funding：

Sichuan Prite Pharmaceutical Co., Ltd

研究疾病：

4-16岁儿童及青少年哮喘急性发作  

Target disease：

Acute asthma exacerbation in children and adolescents aged 4-16 years

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：

本研究以四川普锐特药业有限公司生产的丙酸氟替卡松雾化吸入用混悬液（2ml:0.5mg）为受试制剂，原研GlaxoSmithKline Australia Pty Ltd.生产的丙酸氟替卡松雾化吸入用混悬液（2ml:0.5mg）为参比制剂，评价受试制剂和参比制剂在空腹条件下给药时的生物等效性。  

Objectives of Study：

In this study, the suspension for nebulization inhalation of Fluticasone Propionate (2 ml: 0.5 mg) produced by Sichuan Purity Pharmaceutical Co., Ltd. was used as the test preparation, and the suspension for nebulization inhalation of Fluticasone Propionate (2 ml: 0.5 mg) produced by the original research company GlaxoSmithKline Australia Pty Ltd. was used as the reference preparation. The bioequivalence of the test preparation and the reference preparation when administered under fasting conditions was evaluated.

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.性别：男性和女性健康受试者，且入选的受试者应有适当的性别比例； 2.年龄：18周岁及以上健康受试者（包括18周岁）； 3.体重：男性受试者不应低于50.0kg，女性受试者不应低于45.0kg，身体质量指数【BMI=体重（kg）/身高^2（m^2）】在19.0~26.0kg/m^2范围内（包括边界值）； 4.受试者必须在试验前对本研究知情同意，并自愿签署书面的知情同意书； 5.受试者能够与研究者作良好的沟通，经培训能正确使用雾化吸入器装置，能够依照研究规定完成研究。

Inclusion criteria

1. Gender: male and female healthy subjects, and the enrolled subjects should have an appropriate sex ratio; 2. Age: Healthy subjects aged 18 years and above (including 18 years old); 3. Weight: male subjects should not be less than 50.0kg, female subjects should not be less than 45.0kg, body mass index [BMI = weight (kg)/height^2 (m^2)] within the range of 19.0~26.0kg/m^2 (including boundary value); 4. Subjects must give informed consent to this study before the trial and voluntarily sign a written informed consent form; 5. The subject can communicate well with the investigator, be trained to use the nebulizer device correctly, and be able to complete the study in accordance with the research regulations.

排除标准：

1.对丙酸氟替卡松及其相关化合物和辅料中任何成份过敏者，或对两种及以上药物（或食物）过敏者； 2.不能遵守统一饮食（如对标准餐食物不耐受等）者； 3.不能耐受静脉穿刺者，有晕针晕血史者； 4.存在研究者判断为异常有临床意义的心血管、肝脏、肾脏、内分泌、代谢、消化道、血液系统、呼吸系统、泌尿系统、感染、恶性肿瘤、神经-精神系统等重大病史或现有上述疾病者； 5.在筛选前6个月内接受过重大外科手术者，或者计划在试验期间进行手术者，及凡接受过会影响药物吸收、分布、代谢、排泄的手术者（阑尾炎手术除外）； 6.有哮喘病史或其他呼吸道疾病者（活动性或非活动性肺结核感染者、α-1抗胰蛋白酶缺乏症、支气管扩张症、囊性纤维化、慢性阻塞性肺病、结节病、肺纤维化、肺动脉高压、肺水肿或肺间质病变等）或气道高反应者； 7.未加治疗或治疗后未痊愈的全身性真菌、细菌、病毒或寄生虫感染，或眼部单纯疱疹者； 8.现患有口腔疾病者（如口腔溃疡、口腔黏膜破损、口腔念珠菌病等）； 9.既往或现患有青光眼、白内障者； 10.筛选期体格检查、生命体征监测、心电图检查、胸部CT检查、肺功能检查、实验室检查，经研究者判断异常有临床意义者； 11.乙肝表面抗原、丙肝抗体、梅毒特异性抗体或艾滋病抗体检查结果异常者； 12.既往长期（筛选前3个月内）饮用过量（一天8杯以上，1杯=200mL）茶、咖啡或含咖啡因的饮料者；或试验首次用药前48小时内，摄入任何含有咖啡因的食物或饮料（如咖啡、浓茶、巧克力等）者； 13.试验首次用药前48小时内，摄入过任何富含黄嘌呤或葡萄柚成份或其他影响药物吸收、分布、代谢、排泄等的饮料或食物者； 14.筛选前4周内使用过任何与丙酸氟替卡松有相互作用的药物（如CYP3A4抑制剂如酮康唑、利托那韦等）； 15.试验前6个月内使用过长效雌激素或孕激素注射剂或埋植片者；试验前30天内使用过短效避孕药者； 16.试验首次用药前14天内使用过任何处方药、非处方药、中草药、保健品者； 17.筛选前3个月每日吸烟量多于5支者，或研究首次用药前烟检阳性者以及入选后至整个试验期间不能接受禁止吸烟者； 18.试验首次用药前酒精呼气检查结果阳性，或筛选前6个月内每周饮酒超过14个标准单位（1标准单位含14g酒精，如360mL啤酒或45mL酒精量为40%的烈酒或150mL葡萄酒）； 19.试验首次用药前药物滥用尿液筛查检查结果阳性或试验前1年内有药物滥用史（如吗啡、甲基安非他明、氯胺酮、二亚甲基双氧安非他明、四氢大麻酚酸、可卡因等）者； 20.妊娠或哺乳期妇女或女性受试者血妊娠检查结果阳性者，以及在整个试验期间及研究结束后3个月内有妊娠或捐精捐卵计划，或不愿采取有效的避孕措施的男性受试者（或其伴侣）或女性受试者（具体避孕措施见附录1）； 21.筛选前14天内发生非保护性行为的女性受试者； 22.筛选前3个月内参加了其他临床试验且使用了试验用药品或试验器械者； 23.试验首次用药前3个月内献血或失血≥400mL，或计划在试验期间或试验结束后3个月内献血或血液成分者； 24.研究者认为受试者存在任何其他不适宜参加试验的情况。

Exclusion criteria：

1. Those who are allergic to any of the ingredients in fluticasone propionate and its related compounds and excipients, or those who are allergic to two or more drugs (or food); 2. Those who cannot comply with the uniform diet (such as intolerance to standard meals, etc.); 3. Those who cannot tolerate venipuncture, and those who have a history of fainting and blood sickness; 4. Those who have a history of major diseases such as cardiovascular, liver, kidney, endocrine, metabolic, digestive tract, blood system, respiratory system, urinary system, infection, malignant tumor, neuro-psychiatric system, etc., judged by the investigator to be abnormal and clinically significant, or those who have existing diseases above above; 5. Those who have undergone major surgical operations within 6 months before screening, or those who plan to undergo surgery during the trial, and those who have undergone surgeries that will affect the absorption, distribution, metabolism, and excretion of drugs (except for appendicitis surgery); 6. Those with a history of asthma or other respiratory diseases (active or inactive tuberculosis infection, α-1 antitrypsin deficiency, bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, pulmonary edema or pulmonary interstitial lesions, etc.) or airway hyperreactive; 7. Systemic fungal, bacterial, viral or parasitic infections that have not been treated or have not been cured after treatment, or ocular herpes simplex; 8. Those who are currently suffering from oral diseases (such as oral ulcers, oral mucosal damage, oral candidiasis, etc.); 9. Those who have suffered from glaucoma and cataract in the past or now; 10. Those who have physical examination, vital signs monitoring, electrocardiogram examination, chest CT examination, pulmonary function examination, and laboratory examination during the screening period, and the abnormalities are judged by the investigator to be clinically significant; 11. Those with abnormal test results of hepatitis B surface antigen, hepatitis C antibody, syphilis-specific antibody or AIDS antibody; 12. Those who have drunk excessive amounts of tea, coffee or caffeinated beverages (more than 8 cups a day, 1 cup = 200mL) for a long time (within 3 months before screening) in the past; or those who ingested any food or beverage containing caffeine (such as coffee, strong tea, chocolate, etc.) within 48 hours before the first dose of the trial; 13. Those who have ingested any beverage or food rich in xanthine or grapefruit or other beverages or foods that affect the absorption, distribution, metabolism, and excretion of drugs within 48 hours before the first dose of the test; 14. Use of any drugs that interact with fluticasone propionate within 4 weeks before screening (such as CYP3A4 inhibitors such as ketoconazole, ritonavir, etc.); 15. Those who have used long-acting estrogen or progesterone injections or implants within 6 months before the test; Those who have used short-acting contraceptives within 30 days before the trial; 16. Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, and health care products within 14 days before the first dose of the trial; 17. Those who smoke more than 5 cigarettes per day in the 3 months before screening, or those who have a positive smoking test before the first dose of the study, and those who cannot accept smoking prohibition after selection and the whole trial period; 18. Positive alcohol breath test result before the first dose of the trial, or drinking more than 14 standard units of alcohol per week within 6 months before screening (1 standard unit contains 14g of alcohol, such as 360mL of beer or 45mL of spirits with 40% alcohol or 150mL of wine); 19. Those who have a positive urine screening test result of drug abuse before the first drug use of the test or a history of drug abuse (such as morphine, methamphetamine, ketamine, dimethylenedioxyamphetamine, tetrahydrocannabinolic acid, cocaine, etc.) within 1 year before the test; 20. Pregnant or lactating women or female subjects with positive blood pregnancy test results, as well as male subjects (or their partners) or female subjects who have a pregnancy or sperm donation and egg donation plan during the entire trial period and within 3 months after the end of the study, or who are unwilling to take effective contraceptive measures (see Appendix 1 for specific contraceptive measures); 21. Female subjects who have had non-protective sexual behavior within 14 days prior to screening; 22. Those who have participated in other clinical trials within 3 months before screening and have used investigational drugs or experimental devices; 23. Those who donated or lost 400mL of blood or blood loss within 3 months before the first dose ≥of the trial, or planned to donate blood or blood components during the trial or within 3 months after the end of the trial; 24. In the opinion of the investigator, the subject has any other conditions that are not suitable to participate in the trial.

研究实施时间：

Study execute time：

从 From 2025-05-31 00:00:00至 To 2025-07-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-05-31 00:00:00 至 To 2025-07-31 00:00:00

干预措施：

Interventions：

组别：

B组

样本量：

 18

Group：

Group B

Sample size：

干预措施：

第一周期参比制剂（原研 GlaxoSmithKline Australia Pty Ltd.生产的丙酸氟替卡松雾化吸入用混悬液（2ml:0.5mg））;第二周期受试制剂（四川普锐特药业有限公司生产的丙酸氟替卡松雾化吸入用混悬液（2ml:0.5mg））

干预措施代码：

Intervention：

The first cycle of reference preparation (original GlaxoSmithKline Australia Pty Ltd. production of fluticasone propionate nebulized inhalation suspension (2ml: 0.5mg)); The second cycle of test preparation (fluticasone propionate nebulized inhalation suspension (2ml: 0.5mg) produced by Sichuan Prite Pharmaceutical Co., Ltd.)

Intervention code：

组别：

A组

样本量：

 18

Group：

Group A

Sample size：

干预措施：

第一周期受试制剂（四川普锐特药业有限公司生产的丙酸氟替卡松雾化吸入用混悬液（2ml:0.5mg））;第二周期参比制剂（原研 GlaxoSmithKline Australia Pty Ltd.生产的丙酸氟替卡松雾化吸入用混悬液（2ml:0.5mg））

干预措施代码：

Intervention：

The first cycle of the test preparation (fluticasone propionate aerosol inhalation suspension (2ml: 0.5mg) produced by Sichuan Prite Pharmaceutical Co., Ltd.); Second cycle reference preparation (original GlaxoSmithKline Australia Pty Ltd. fluticasone propionate nebulized inhalation suspension (2ml: 0.5mg))

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 河北 

市(区县)：

  

Country：

China

Province：

Hebei

City：

单位(医院)：

 邢台医学高等专科学校第二附属医院 

单位级别：

 三级 

Institution
hospital：

The Second Affiliated Hospital Of Xingtai Medical College

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

峰浓度

指标类型：

主要指标

Outcome：

Cmax

Type：

Primary indicator

测量时间点：

0h及给药后6min、10min、15min、20min、25min、30min、40min、50min、1h、1.25h、1.5h、1.75h、2h、3h、5h、6h、8h、12h、24h、48h

测量方法：

Measure time point of outcome：

0h、6min、10min、15min、20min、25min、30min、40min、50min、1h、1.25h、1.5h、1.75h、2h、3h、5h、6h、8h、12h、24h、48h

Measure method：

指标中文名：

零到t时间的药时曲线下面积

指标类型：

主要指标

Outcome：

AUC0-t

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

零到无穷大时间的药时曲线下面积

指标类型：

主要指标

Outcome：

AUC0-∞

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：

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）：

由统计单位应用SAS（9.4或以上版本）软件采用区组随机生成受试者随机分配表

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

The statistical unit used SAS (version 9.4 or above) software to randomly generate the participant randomization table using the group

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）：

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：

本试验数据采集/管理系统为EDC系统，数据管理员根据方案设计eCRF，eCRF中包含除外部数据结果外方案中规定的全部数据点。由EDC系统直接导出eCRF（PDF格式），经申办方审查和批准后定稿。

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

The data collection/management system for this experiment is an EDC system. The data administrator designs eCRF according to the plan, which includes all data points specified in the plan except for external data results. Export eCRF directly from the EDC system (in PDF format), and finalize it after review and approval by the sponsor.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-05-23 09:34:29