ChiCTR2400090462 版本V1.0 版本创建时间2024/09/30 11:55:11 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：

ChiCTR2400090462 

最近更新日期：

Date of Last Refreshed on：

2024-09-30 11:54:56 

注册时间：

Date of Registration：

2024-09-30 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

丙酸氟替卡松乳膏的人体药代动力学对比研究

Public title：

Comparative study on pharmacokinetics of fluticasone propionate cream in humans

注册题目简写：

English Acronym：

研究课题的正式科学名称：

丙酸氟替卡松乳膏的人体药代动力学对比研究

Scientific title：

Comparative study on pharmacokinetics of fluticasone propionate cream in humans

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：

唐哲 

研究负责人：

杨水新 

Applicant：

Tang zhe 

Study leader：

Yang Shuixin 

申请注册联系人电话：

Applicant telephone：

+86 156 7587 4194

研究负责人电话：

Study leader's telephone：

+86 138 1923 3850

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：

1521835783@qq.com

研究负责人电子邮件：

Study leader's E-mail：

phase1@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：

浙江省湖州市吴兴区三环北路1558号

研究负责人通讯地址：

浙江省湖州市吴兴区三环北路1558号

Applicant address：

1558 Sanhuan North Road, Wuxing District, Huzhou City, Zhejiang Province

Study leader's address：

1558 Sanhuan North Road, Wuxing District, Huzhou City, Zhejiang 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：

湖州市中心医院

Applicant's institution：

Huzhou Central Hospital

研究负责人所在单位：

湖州市中心医院

Affiliation of the Leader：

Huzhou Central Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2024-048(Y)-01

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：

湖州市中心医院临床试验伦理委员会

Name of the ethic committee：

Clinical Trial Ethics Committee of Huzhou Central Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024-09-06 00:00:00

伦理委员会联系人：

范胜楠

Contact Name of the ethic committee：

Fan Shengnan

伦理委员会联系地址：

浙江省湖州市吴兴区三环北路1558号

Contact Address of the ethic committee：

1558 Sanhuan North Road, Wuxing District, Huzhou City, Zhejiang Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 572 270 9719

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

湖州市中心医院

Primary sponsor：

Huzhou Central Hospital

研究实施负责（组长）单位地址：

浙江省湖州市吴兴区三环北路1558号

Primary sponsor's address：

1558 Sanhuan North Road, Wuxing District, Huzhou City, Zhejiang 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)：

浙江

市(区县)：

Country：

China

Province：

Zhejiang

City：

单位(医院)：

浙江仙琚制药股份有限公司

具体地址：

浙江省仙居县福应街道现代工业集聚区丰溪西路15号

Institution
hospital：

Zhejiang Xianju Pharmaceutical Co., Ltd.

Address：

No. 15 Fengxi West Road, Modern Industrial Agglomeration Zone, Fuying Street, Xianju County, Zhejiang Province

经费或物资来源：

浙江仙琚制药股份有限公司

Source(s) of funding：

Zhejiang Xianju Pharmaceutical Co., Ltd.

Target disease：

Eczema/dermatitis

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：

以健康受试者为研究对象，受试制剂丙酸氟替卡松乳膏（规格：0.05% 15g:7.5mg/支，浙江仙琚制药股份有限公司）与参比制剂丙酸氟替卡松乳膏（商品名：Cutivate?，规格：0.05% 15g:7.5mg/支，GlaxoSmithKline (Ireland) Limited公司持证），通过药代动力学对比研究，评价受试制剂与参比制剂的体内暴露和安全性。  

Objectives of Study：

Taking healthy subjects as the research subjects, the test formulation fluticasone propionate cream (specification: 0.05% 15g: 7.5mg/vial, Zhejiang Xianju Pharmaceutical Co., Ltd.) and the reference formulation fluticasone propionate cream (trade name: Cutivate ?, Specification: 0.05% 15g: 7.5mg/vial, certified by GlaxoSmithKline (Ireland) Limited. Evaluate the in vivo exposure and safety of the test and reference formulations through pharmacokinetic comparative studies.

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.签署知情同意书当日年龄18至60周岁（含边界值），男女均可；男性体重≥50kg，女性体重≥45 kg；体重指数（BMI）≥18 kg/m2且≤30 kg/m2； 2.承诺给药前24 h至试验结束不在背部使用乳膏、润肤剂或其他类似产品； 3.承诺在试验期间不擅自洗浴，不从事任何剧烈或容易引起疲劳的活动； 4.有生育能力的受试者（男性或女性）必须同意在试验期间和末次给药后3个月内采用一种经医学认可的避孕措施，并且在试验期间及试验结束后3个月内无捐献精子/卵子计划； 5.自愿参加本次临床试验，能与研究者良好沟通，遵从整个研究的要求，且签署了书面的知情同意书。

Inclusion criteria

1.On the day of signing the informed consent form, the age range is 18 to 60 years old (including threshold values), and both males and females are eligible; Male weight ≥ 50kg, female weight ≥ 45kg; Body mass index (BMI) ≥ 18 kg/m2 and ≤ 30 kg/m2; 2. Promise not to use cream, moisturizer or other similar products on the back 24 hours before administration until the end of the trial; 3. Promise not to take baths or engage in any strenuous or fatigue inducing activities without authorization during the trial period; 4. Subjects with fertility (male or female) must agree to use a medically approved contraceptive measure during the trial period and within 3 months after the last dose , and have no plans to donate sperm/eggs during the trial period and within 3 months after the end of the trial; 5. Voluntarily participate in this clinical trial, communicate well with the researchers, comply with the requirements of the entire study, and sign a written informed consent form.

排除标准：

1.既往或目前正患有循环系统、内分泌系统、神经系统、消化系统、呼吸系统、血液学、免疫学、精神病学及代谢异常等重大疾病，且研究者认为可能干扰试验结果或可能对受试者参加试验带来潜在危害的任何疾病； 2.有药物、两种及以上食物或其他物质过敏史，特别是对外用或全身用皮质激素、丙酸氟替卡松或任一药物辅料有过敏史者，或者外用或系统用糖皮质激素曾发生过不良反应者； 3.正在使用药物，尤其是作用于血管的药物（收缩剂或舒张剂）、能够调节血流的处方药或非处方药，如硝酸甘油、抗高血压药、抗组胺药、非甾体类抗炎药、阿司匹林、含抗组胺药或/和苯丙醇胺或酚妥拉明的非处方药； 4.筛选前1个月内背部皮肤使用过外用药物，或在任何部位皮肤使用过外用皮质激素类药物； 5.筛选前6个月内有酗酒史，即平均每周饮酒超过14单位酒精（1单位=360 mL啤酒或45 mL酒精量为40%的白酒或150 mL葡萄酒）者，或酒精呼气试验结果大于0.0 mg/100mL； 6.筛选前3个月内平均每日吸烟大于10支者，或在研究期间无法停止使用任何形式的烟草； 7.每周期给药前48 h至试验结束无法停止食用含咖啡因、酒精类等饮料和食品（包括巧克力、茶、咖啡、可乐等），或富含黄嘌呤成分的食物（如沙丁鱼、动物肝脏等）或葡萄柚、葡萄柚产品、火龙果、芒果、柚子、橘子、杨桃、番石榴等影响药物代谢的食品； 8.筛选前6个月有药物滥用史（包括非医疗目的地使用各类麻醉药品和精神药品）或尿液药物筛查（包括：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）阳性； 9.筛选时生命体征检查、体格检查、临床实验室检查（血常规、尿常规、血生化、传染病筛查、凝血功能）和12-导联心电图检查，结果显示异常有临床意义者； 10.筛选前3个月内参加过其它临床试验者； 11.筛选前3个月内有献血行为者，6个月内献血或其他原因失血总和达到或超过400 mL者（女性生理期失血除外），或计划在研究期间或研究结束后1周内献血或血液成份者； 12.筛选前2周内使用过任何药物者（包括处方药、非处方药、中草药制剂及方剂等）； 13.筛选前6个月内接受过经研究者判断会影响药物吸收、分布、代谢、排泄的手术者，或计划在研究期间进行手术； 14.筛选前4周内接种过疫苗，或计划在试验期间接种任何疫苗者； 15.静脉穿刺采血不耐受、晕针或晕血史者； 16.对饮食有特殊要求或乳糖不耐受，不能接受统一饮食； 17.女性受试者筛选前14天内与伴侣发生非保护性性行为； 18.妊娠或哺乳期女性，或女性受试者血妊娠检查阳性者； 19.根据研究者的判断，有其他不适宜入组情况者。

Exclusion criteria：

1. Any major diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities that the researcher believes may interfere with the trial results or potentially harm the subjects' participation in the trial; 2. Individuals with a history of allergies to drugs, two or more types of food, or other substances, especially to corticosteroids, fluticasone propionate, or any drug excipients used externally or systemically, or who have experienced adverse reactions to corticosteroids used externally or systemically; 3. Currently using medication, especially drugs that act on blood vessels (constrictors or relaxants), prescription or over-the-counter drugs that can regulate blood flow, such as nitroglycerin, antihypertensive drugs, antihistamines, nonsteroidal anti-inflammatory drugs, aspirin, over-the-counter drugs containing antihistamines and/or phenylpropanolamine or phentolamine; 4. Have used topical medications on the back skin or have used topical corticosteroids on any part of the skin within the previous month of screening; 5. Have a history of alcoholism within 6 months before screening, that is, drink more than 14 units of alcohol (1 unit=360 mL beer or 45 mL Baijiu or 150 mL wine with 40% alcohol) every week on average, or the alcohol breath test result is greater than 0.0 mg/100mL; 6. Those who smoke an average of more than 10 cigarettes per day within the first 3 months of screening, or are unable to stop using any form of tobacco during the study period; 7. From 48 hours before the weekly administration to the end of the test, it is impossible to stop eating caffeine, alcohol and other beverages and foods (including chocolate, tea, coffee, cola, etc.), or foods rich in xanthine (such as sardine, animal liver, etc.) or grapefruit, grapefruit products, pitaya, mango, pomelo, orange, carambola, guava and other foods that affect drug metabolism; 8. Individuals with a history of drug abuse (including non-medical use of various types of narcotics and psychotropic drugs) or positive urine drug screening (including morphine, methamphetamine, ketamine, methylenedioxymethamphetamine, tetrahydrocannabinol) within the first 6 months of screening; 9. During screening, vital signs examination, physical examination, clinical laboratory examination (blood routine, urine routine, blood biochemistry, infectious disease screening, coagulation function), and 12 lead electrocardiogram examination show clinically significant abnormalities; 10. Select individuals who have participated in other clinical trials within the previous 3 months; 11. Individuals who have donated blood within the past 3 months, those who have lost 400 mL or more of blood due to blood donation or other reasons within the past 6 months (excluding menstrual bleeding in females), or those who plan to donate blood or blood components during the study period or within 1 week after the end of the study; 12. Screening for individuals who have used any medication within the past 2 weeks (including prescription drugs, over-the-counter drugs, herbal preparations, and prescriptions); 13. Select individuals who have undergone surgery within the previous 6 months that, according to the researcher's assessment, may affect drug absorption, distribution, metabolism, and excretion, or who plan to undergo surgery during the study period; 14. Those who have received the vaccine within the previous 4 weeks or plan to receive any vaccine during the trial period; 15. Those who are intolerant to venipuncture blood collection, have a history of needle or blood dizziness; 16. If there are special dietary requirements or lactose intolerance, a unified diet cannot be accepted; 17. Female participants engaged in unprotected sexual activity with their partners within 14 days prior to screening; 18. Pregnant or lactating women, or female subjects with positive blood pregnancy test results; According to the researcher's judgment, there are other situations that are not suitable for inclusion. AI

研究实施时间：

Study execute time：

从 From 2024-10-10 00:00:00至 To 2025-01-10 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-10-12 00:00:00 至 To 2024-10-20 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：

受试者在第一周期用受试制剂，第二周期用参比制剂。

干预措施代码：

Intervention：

The subjects took the test formulation in the first cycle and the reference formulation in the second cycle.

Intervention code：

组别：

R-T组

样本量：

6

Group：

R-TGroup

Sample size：

干预措施：

受试者在第一周期用参比制剂，第二周期用受试制剂。

干预措施代码：

Intervention：

The subjects tookthe reference formulation in the first cycle and the test formulation in the second cycle.

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)：

湖州市中心医院 

单位级别：

三甲甲等 

Institution
hospital：

Huzhou Central Hospital

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：

Cmax

Type：

Primary indicator

测量时间点：

18个采血点

测量方法：

根据血药浓度-时间实测数据直接获得

Measure time point of outcome：

18 blood collection points

Measure method：

Directly obtained from the measured data of blood drug concentration time.

指标中文名：

达峰时间

指标类型：

主要指标

Outcome：

Tmax

Type：

Primary indicator

测量时间点：

18个采血点

测量方法：

根据血药浓度-时间实测数据直接获得

Measure time point of outcome：

18 blood collection points

Measure method：

Directly obtained from the measured data of blood drug concentration time.

指标中文名：

从给药到可最后一个检测最低血药浓度的时间t的曲线下面积

指标类型：

主要指标

Outcome：

AUC0-t

Type：

Primary indicator

测量时间点：

18个采血点

测量方法：

通过线性梯形法则计算

Measure time point of outcome：

18 blood collection points

Measure method：

Calculate using the linear trapezoidal rule

指标中文名：

从给药到外推至无穷远时间的曲线下面积

指标类型：

主要指标

Outcome：

AUC0-∞

Type：

Primary indicator

测量时间点：

18个采血点

测量方法：

AUC0-∞=AUC0-t+Ct/λz，Ct是最后可测量浓度，λz是消除速率常数

Measure time point of outcome：

18 blood collection points

Measure method：

AUC0- ∞=AUC0-t+Ct/ λ z. Ct is the final measurable concentration, λ Z is the elimination rate constant

指标中文名：

消除速率常数

指标类型：

主要指标

Outcome：

λz

Type：

Primary indicator

测量时间点：

18个采血点

测量方法：

使用线性回归方法计算的半对数药时曲线终末段的斜率，取斜率的相反数

Measure time point of outcome：

18 blood collection points

Measure method：

Calculate the slope of the final segment of the semi logarithmic drug time curve using linear regression method, taking the opposite of the slope

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 60 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）：

在筛选时，每名受试者将使用筛选号进行识别，筛选号按照签署知情同意书的先后顺序进行排序，以S+三位阿拉伯数字表示，如S001。 筛选合格的受试者将在D-1天按照筛选号从小到大获得随机号：随机号以1+三位阿拉伯数字表示，如1001~1012。纳入研究中的每名受试者给药顺序将由随机表确定。

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

During screening, each subject will be identified using a screening number, which will be sorted in the order of signing the informed consent form and represented by S+three Arabic numerals, such as S001. Qualified subjects will receive a random number from the screening number in ascending order on Day D-1: the random number is represented by 1+three Arabic numerals, such as 1001~1012. The order of administration for each subject included in the study will be determined by a random table.

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 tags

是否共享原始数据：

IPD sharing

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）：

NA

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

NA

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：

NA

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

NA

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：

  2024-09-30 11:54:56