ChiCTR2300068553 版本V1.2 版本创建时间2023/02/23 10:16:26 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：

 ChiCTR2300068553 

最近更新日期：

Date of Last Refreshed on：

 2023-02-23 10:15:53 

注册时间：

Date of Registration：

 2023-02-23 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

糠酸莫米松鼻喷雾剂在健康受试者中的单中心、随机、开放、两制剂、两序列、交叉设计的生物等效性临床试验

Public title：

Mometasone furoate nasal spray in a single-center, randomized, open-label, two-formulation, two-sequence, cross-designed bioequivalence clinical trial in healthy subjects

注册题目简写：

English Acronym：

研究课题的正式科学名称：

糠酸莫米松鼻喷雾剂在健康受试者中的单中心、随机、开放、两制剂、两序列、交叉设计的生物等效性临床试验

Scientific title：

Mometasone furoate nasal spray in a single-center, randomized, open-label, two-formulation, two-sequence, cross-designed bioequivalence clinical trial 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：

孙思平 

研究负责人：

陈桂玲 

Applicant：

Sun Sipin 

Study leader：

Chen Guilin 

申请注册联系人电话：

Applicant telephone：

 15695710737

研究负责人电话：

Study leader's
telephone：

18343113983

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：

 jylin@cuizepharma.com

研究负责人电子邮件：

Study leader's E-mail：

 chenguiling707@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：

浙江省杭州市经济技术开发区白杨街道25号路339号2幢3A03室

研究负责人通讯地址：

杭州市下城区东新路848号

Applicant address：

Room 3A03, Building 2, No. 339, No. 25 Road, Baiyang Street, Hangzhou Economic and Technological Development Zone, Zhejiang Province

Study leader's address：

No. 848, Dongxin Road, Xiacheng District, Hangzhou

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：

浙江萃泽医药科技有限公司

Applicant's institution：

Zhejiang Cuize Pharmaceutical Technology Co., Ltd

研究负责人所在单位：

树兰（杭州）医院

Affiliation of the Leader：

Shulan (Hangzhou) 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：

 2023伦审第（1）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：

树兰（杭州）医院临床试验伦理委员会

Name of the ethic committee：

Clinical Trial Ethics Committee of Shulan (Hangzhou) Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-01-11 00:00:00

伦理委员会联系人：

Guan Wenhua

Contact Name of the ethic committee：

Guan Wenhua

伦理委员会联系地址：

杭州市下城区东新路848号

Contact Address of the ethic committee：

No. 848, Dongxin Road, Xiacheng District, Hangzhou

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 571 56131318

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：

树兰（杭州）医院

Primary sponsor：

Shulan(Hangzhou) Hosipital

研究实施负责（组长）单位地址：

杭州市下城区东新路848号

Primary sponsor's address：

No. 848, Dongxin Road, Xiacheng District, Hangzhou

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)：

杭州

Country：

China

Province：

Zhejiang

City：

Hangzhou

单位(医院)：

浙江仙琚医药科技有限公司

具体地址：

钱塘新区白杨街道25号

Institution
hospital：

Zhejiang Xianju Pharmaceutical Technology Co., Ltd

Address：

25 Baiyang Street, Qiantang New District

国家：

中国

省(直辖市)：

浙江

市(区县)：

杭州

Country：

China

Province：

Zhejiang

City：

Hangzhou

单位(医院)：

树兰（杭州）医院

具体地址：

拱墅区东新路848号

Institution
hospital：

Shulan (Hangzhou) Hospital

Address：

848 Dongxin Road, Gongshu District

经费或物资来源：

浙江仙琚医药科技有限公司

Source(s) of funding：

Zhejiang Xianju Pharmaceutical Technology Co., Ltd

研究疾病：

中至重度季节性过敏性鼻炎症状  

Target disease：

Moderate to severe seasonal allergic rhinitis symptoms

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：

主要目的：以浙江仙琚医药科技有限公司提供的糠酸莫米松鼻喷雾剂（规格：每瓶60揿，每揿含糠酸莫米松50μg，药物浓度为0.05%（g/g））作为受试制剂，以MSD Belgium BVBA/SPRL持有的糠酸莫米松鼻喷雾剂（规格：每瓶60揿，每揿含糠酸莫米松50μg，药物浓度为0.05%（g/g）；商品名：Nasonex?/内舒拿?）作为参比制剂，评价受试制剂（T）和参比制剂（R）在空腹条件下给药的生物等效性。 次要目的：考察受试制剂（T）和参比制剂（R）在健康受试者中的安全性。  

Objectives of Study：

Main purpose: to take the mometasone furoate nasal spray provided by Zhejiang Xianju Pharmaceutical Technology Co., Ltd. (specification: 60 mug per bottle, 50μg of mometasone furoate per bottle, drug concentration of 0.05% (g/g)) as the test preparation, with MSD Belgium BVBA/SPRL held by Mometasone furoate nasal spray (specification: 60 mug per bottle, 50μg mometasone furoate per bottle, drug concentration of 0.05% (g/g); Trade Name: Nasonex?/Nesuna ?) as a reference preparation to evaluate the bioequivalence of the test preparation (T) and the reference preparation (R) administered under fasting conditions. Secondary objective: To investigate the safety of the test preparation (T) and reference preparation (R) in 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 试验前签署知情同意书，并对试验内容、过程及可能出现的不良反应充分了解；
2 能够按照试验方案要求完成研究；
3 受试者（包括伴侣）自给药前2周至最后一次研究药物给药后6个月内无妊娠计划且自愿采取有效避孕措施，具体避孕措施见附录一；
4 年龄为18～65周岁男性和女性受试者（包括临界值）；
5 男性受试者体重不低于50公斤、女性受试者体重不低于45公斤。体重指数（BMI）＝体重（kg）/身高2（m2），体重指数在18.0~28.0 kg/m2范围内（包括临界值）；
6 体格检查、生命体征正常或异常无临床意义。

Inclusion criteria

1 Sign the informed consent form before the trial, and fully understand the content, process and possible adverse reactions of the test;
2. Be able to complete the study in accordance with the requirements of the test protocol;
3 Participants (including partners) had no pregnancy plan and voluntarily adopted effective contraception from 2 weeks before administration to 6 months after the last study drug administration, as shown in Appendix 1 for specific contraceptive measures;
4 Male and female subjects aged 18~65 years (including cut-off values);
5 Male subjects weighed at least 50 kg and female subjects weighed at least 45 kg. Body mass index (BMI) = body weight (kg) / height 2 (m2), body mass index in the range of 18.0~28.0 kg/m2 (including critical value);
6 Physical examination and vital signs are normal or abnormal and have no clinical significance.

排除标准：

1 筛选前6个月吸烟者/未戒烟者；或试验期间不能停止使用任何烟草类产品，或烟碱筛查结果阳性；
2 对本品或其他糖皮质激素有过敏史，过敏体质（两种或两种以上药物、食物及环境过敏，尤其是大豆、酒精、鸡蛋）者；
3 筛选前6个月内经常饮酒者，即每周饮酒超过14单位酒精（1单位=360 mL啤酒或45 mL酒精量为40%的烈酒或150mL葡萄酒），或者不能保证试验期间放弃饮酒者；
4 筛选前3个月内献血或大量失血（>400 mL）者；
5 筛选前3个月内接受过手术或计划在试验期间接受手术者，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/皮肤手术除外）；
6 患有活动性或静止性结核病史者；
7 有急性上呼吸道感染者；
8 筛选前1个月服用了任何影响 CYP3A4 酶（如酮康唑、伊曲康唑、克拉霉素、利托那韦、含可比司他产品等）的药物者，详见附录六；
9 筛选前14天内服用了任何处方药、非处方药、任何维生素产品或草药，或接种过疫苗者；
10 筛选前3个月内每天饮用过量茶、咖啡和/或含咖啡因的饮料（8杯以上，1杯=250 mL）者；
11 对饮食有特殊要求，不能接受统一饮食，或最近在饮食或运动习惯上有重大变化者；
12 给药前3个月内服用过研究药品、使用过糖皮质激素治疗或参加了药物临床试验者；
13 筛选时外鼻部检查或口咽部检查异常有临床意义者；
14 有白内障、青光眼、结膜炎或目前患有其它眼部感染者；
15 静脉条件差，或由于纹身造成采血困难，或不能耐受静脉穿刺术者；
16 心电图、胸部X线/CT检查后经研究者判断异常有临床意义者；
17 女性受试者在筛查期或试验过程中正处在哺乳期或血清妊娠结果阳性；
18 临床实验室检查有临床意义异常、或其它临床发现显示有临床意义的下列疾病，包括但不限于胃肠道、肾、肝、神经、血液、内分泌、肿瘤、肺、免疫、呼吸系统（a.病史有长期鼻塞、流涕、头痛、鼻出血等症状；b.哮喘、慢性呼吸道疾病等；c.过敏性鼻炎、慢性鼻炎、鼻窦炎病史）、精神或心脑血管疾病；
19 病毒性肝炎（包括乙肝和丙肝）、艾滋病抗体、梅毒螺旋体抗体筛选阳性者；
20 从筛选阶段至研究给药前发生急性疾病者；
21 给药前48小时内食用过火龙果、芒果、柚子、酸橙、杨桃或由其制备的食物或饮料者；
22 给药前48小时内摄取了巧克力、任何含咖啡因或富含黄嘌呤食物或饮料者；
23 给药前48小时内服用过任何含酒精的制品；
24 酒精或毒品筛查阳性或在过去五年内有药物滥用史；
25 研究者认为受试者不适合参加试验。

Exclusion criteria：

1 Smokers/non-quitters screened in the previous 6 months; or the use of any tobacco-based product cannot be stopped during the test, or the nicotine screening result is positive;
2 Those who have a history of allergy to this product or other glucocorticoids, allergic constitution (two or more drugs, food and environmental allergies, especially soy, alcohol, eggs);
3 Regular drinkers in the 6 months prior to screening, i.e. those who drank more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits or 150 mL of wine with 40% alcohol), or who were not guaranteed to give up drinking during the trial period;
4 Those who donated blood or lost a large amount of blood (> 400 mL) within 3 months before screening;
5 Those who have undergone surgery within 3 months prior to screening or plan to undergo surgery during the trial, and those who have undergone surgery that will affect drug absorption, distribution, metabolism and excretion (except appendicitis/skin surgery);
6 People with a history of active or stationary tuberculosis;
7 People with acute upper respiratory tract infection;
8 Those who took any drugs that affect CYP3A4 enzymes (such as ketoconazole, itraconazole, clarithromycin, ritonavir, products containing cobistita, etc.) 1 month before screening, see Appendix 6 for details;
9 Those who have taken any prescription drug, over-the-counter drug, any vitamin product or herbal medicine, or have been vaccinated within 14 days prior to screening;
10 Those who consumed excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day for the 3 months prior to screening;
11. Those who have special dietary requirements, cannot accept a unified diet, or have recently had significant changes in diet or exercise habits;
12. Those who have taken investigational drugs, used glucocorticoids or participated in drug clinical trials within 3 months prior to administration;
13 Abnormal external nasal examination or oropharyngeal examination at the time of screening with clinical significance;
14 Those with cataracts, glaucoma, conjunctivitis or other eye infections;
15 Those with poor vein condition, or difficulty in blood collection due to tattoos, or inability to tolerate venipuncture;
16 After electrocardiogram, chest X-ray/CT examination, the investigator judged that the abnormality was clinically significant;
17. Female subjects were breastfeeding or had a positive serum pregnancy result during the screening period or during the trial;
18 Clinical laboratory tests have abnormal clinical significance, or other clinical findings show clinically significant diseases of the following diseases, including but not limited to gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immunological, respiratory system (a. history with long-term nasal congestion, runny nose, headache, nosebleeds and other symptoms; b. Asthma, chronic respiratory diseases, etc.; c. History of allergic rhinitis, chronic rhinitis, sinusitis), psychiatric or cardiovascular and cerebrovascular diseases;
19 Positive screening for viral hepatitis (including hepatitis B and C), AIDS antibody, and treponemal antibody;
20 Acute illness from the screening stage to the study administration;
21 Those who have consumed dragon fruit, mango, grapefruit, lime, star fruit or food or beverages prepared by them within 48 hours before administration;
22 Those who ingest chocolate, any caffeinated or xanthine-rich food or beverage within 48 hours prior to administration;
23 Have taken any alcohol-containing product within 48 hours prior to administration;
24 positive alcohol or drug screening or history of substance abuse within the past five years;
25 The investigators deemed participants unsuitable to participate in the trial.

研究实施时间：

Study execute time：

从 From 2023-01-22 00:00:00至 To 2024-01-20 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-02-22 00:00:00 至 To 2024-01-20 00:00:00

干预措施：

Interventions：

组别：

实验组

样本量：

 22

Group：

Experimental group

Sample size：

干预措施：

第一周期接受受试制剂200ug，期间清洗期为7天，第二周期接受参比制剂200ug

干预措施代码：

Intervention：

In the first period, 200 ug of the test preparation was accepted, and the cleaning period was 7 days. In the second period, 200 ug of the reference preparation was accepted

Intervention code：

组别：

对照组

样本量：

 22

Group：

Control group

Sample size：

干预措施：

第一周期接受参比制剂200ug，期间清洗期为7天，第二周期接受受试制剂200ug

干预措施代码：

Intervention：

In the first period, 200 ug of reference preparation was accepted, and the cleaning period was 7 days. In the second period, 200 ug of test preparation was accepted

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)：

 树兰（杭州）医院 

单位级别：

 三甲 

Institution
hospital：

Shulan (Hangzhou) Hosipital

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

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

零时间到最终采血点（t）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 concentration-time curve from zero time to the final collection point (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：

零时间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 concentration curve from zero time to infinite time

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

达峰时间

指标类型：

次要指标

Outcome：

Peak time

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

消除终末端半衰期

指标类型：

次要指标

Outcome：

Eliminate the terminal half-life

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

消除速率常数

指标类型：

主要指标

Outcome：

Elimination rate constant

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 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）：

研究中每名受试者接受的用药方案顺序“TR”或“RT”将由随机表确定。随机表使用SAS（9.4或以上版本）的生成，44例受试者按照1:1的比例随机分配至TR、RT两个序列组，每组22人。

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

The sequence of regimens "TR" or "RT" received by each participant in the study will be determined by a random table. The randomization table was generated using SAS (version 9.4 or above), and 44 subjects were randomly assigned to two sequence groups of TR and RT in a 1:1 ratio, with 20 peo

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：

Blinding：

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）：

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：

无/No

注册人：

Name of Registration：

  2023-02-23 10:14:21