ChiCTR2100045456 版本V1.5 版本创建时间2021/11/29 15:23:18 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：

 ChiCTR2100045456 

最近更新日期：

Date of Last Refreshed on：

 2021-11-29 15:19:54 

注册时间：

Date of Registration：

 2021-04-15 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

地奈德乳膏的人体药代动力学对比研究

Public title：

Comparative study on human pharmacokinetics of desonide cream

注册题目简写：

English Acronym：

研究课题的正式科学名称：

地奈德乳膏的人体药代动力学对比研究

Scientific title：

Comparative study on human pharmacokinetics of desonide cream

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：

胡展晴 

研究负责人：

阳国平 

Applicant：

Hu Zhanqing 

Study leader：

Yang Guoping 

申请注册联系人电话：

Applicant telephone：

 +86 15607310928

研究负责人电话：

Study leader's
telephone：

+86 731 89918665

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：

 1390178555@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 1390178555@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：

湖南省长沙市河西岳麓区桐梓坡路138号

研究负责人通讯地址：

湖南省长沙市河西岳麓区桐梓坡路138号

Applicant address：

138 Tongzipo Road, Hexiyuelu District, Changsha, Hunan, China

Study leader's address：

138 Tongzipo Road, Hexiyuelu District, Changsha, Hunan, China

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：

中南大学湘雅三医院临床试验研究中心

Applicant's institution：

Clinical Trial Research Center of Xiangya Third Hospital of Central South University

研究负责人所在单位：

中南大学湘雅三医院临床试验研究中心

Affiliation of the Leader：

Clinical Trial Research Center of Xiangya Third Hospital of Central South University

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21056

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：

中南大学湘雅三医院伦理委员会医学伦理分委员会

Name of the ethic committee：

Ethics Committee of Xiangya Third Hospital of Central South University

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-03-30 00:00:00

伦理委员会联系人：

王晓敏

Contact Name of the ethic committee：

Wang Xiaomin

伦理委员会联系地址：

湖南省长沙市河西岳麓区桐梓坡路138号

Contact Address of the ethic committee：

138 Tongzipo Road, Hexiyuelu District, Changsha, Hunan, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

中南大学湘雅三医院临床试验研究中心

Primary sponsor：

Clinical trial research center of Xiangya Third Hospital of Central South University

研究实施负责（组长）单位地址：

中国湖南省长沙市岳麓区桐梓坡路138号

Primary sponsor's address：

138 Tongzipo Road, Hexiyuelu District, Changsha, Hunan, China

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)：

长沙

Country：

China

Province：

Hunan

City：

Changsha

单位(医院)：

中南大学湘雅三医院临床试验研究中心

具体地址：

河西岳麓区桐梓坡路138号

Institution
hospital：

Clinical trial research center of Xiangya Third Hospital of Central South University

Address：

138 Tongzipo Road, Hexiyuelu District

经费或物资来源：

湖北生物医药产业技术研究院有限公司

Source(s) of funding：

Hubei Biomedical Industry Technology Research Institute Co., Ltd.

研究疾病：

缓解皮质类固醇反应性皮肤炎的炎症和瘙痒症状  

Target disease：

Relieve inflammation and itching symptoms of corticosteroid-responsive dermatitis

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：

以湖北人福成田药业有限公司生产的地奈德乳膏为受试制剂，Perrigo New York Inc生产的地奈德乳膏（0.05%，Perrigo?）为参比制剂，研究局部给药后受试制剂与参比制剂的体内暴露量比，从而评价受试制剂的安全性。  

Objectives of Study：

The desonide cream produced by Hubei Renfu Chengtian Pharmaceutical Co., Ltd. is used as the test preparation, and the desonide cream (0.05%, Perrigo?) produced by Perrigo New York Inc is used as the reference preparation. The in vivo exposure ratio of the test preparation and the reference preparation to evaluate the safety of the test preparation.

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.年龄在18周岁至60周岁（含边界值）的中国健康志愿者，男女均可；
2.男性志愿者的体重≥50.0 kg，女性志愿者的体重≥45.0 kg，体重指数（BMI）在19 ~ 28 kg/m2之间，含临界值；
3.志愿者自愿签署书面的知情同意书。

Inclusion criteria

1. Chinese healthy volunteers aged from 18 to 60 years old (including boundary value), both male and female;
2. The weight of male volunteers was more than or equal to 50.0 kg, and that of female volunteers was more than or equal to 45.0 kg. The body mass index (BMI) was between 19 and 28 kg / m2, including the critical value;
3. Volunteers who voluntarily sign written informed consent.

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、泌尿生殖系统、血液学、免疫学、精神病学及代谢异常等任何临床严重疾病者或能干扰试验结果的任何其他疾病；
2.有药物、食物或其他物质过敏史；
3.试验前4周内接受过外科手术，或计划在研究期间进行外科手术者；
4.试验前14天内服用过任何药物者或保健品（包括中草药）；
5.试验前30天内使用过任何抑制或诱导肝脏对药物代谢的药物（如：诱导剂—巴比妥类、卡马西平、苯妥英、糖皮质激素、奥美拉唑；抑制剂—SSRI类抗抑郁药、西咪替丁、地尔硫卓、大环内酯类、硝基咪唑类、镇静催眠药、维拉帕米、氟喹诺酮类、抗组胺类）者；
6.研究前1个月内使用了外用皮科药物治疗者；
7.研究前1个月内接种过疫苗或减毒活疫苗，或计划会在研究期间接种疫苗者；
8.试验前3个月内参加任何临床试验且服用了任何临床试验药物者；
9.在入选前3个月内献血或大量失血（≥200 mL，不包括女性月经期失血）、接受输血或使用血制品者；
10.双腿和双臂毛发旺盛者；
11.妊娠或哺乳期妇女，以及受试者试验期间不能采用一种或一种以上的非药物避孕措施者；
12.对饮食有特殊要求，不能遵守统一饮食者；
13.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；
14.嗜烟者或试验前3个月每日吸烟量多于5支者或试验期间不能停止使用任何烟草类产品者；
15.酗酒者或试验前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150 mL葡萄酒）或试验期间不能停止使用任何含酒精产品者；
16.药物滥用者或试验前3个月使用过软毒品（如：大麻）或试验前1年服用硬毒品（如：可卡因、苯环己哌啶等）者；
17.生命体征异常者（收缩压<90 mmHg或>140 mmHg，舒张压<50 mmHg或>90 mmHg；心率<50 bpm或>100 bpm）或体格检查、心电图、实验室检查异常有临床意义（以临床研究医生判断为准）；
18.受试者可能因为其他原因而不能完成本研究或研究者认为不应纳入者。

Exclusion criteria：

1. Patients who have suffered or are suffering from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities, or any other diseases that can interfere with the test results;
2. Patients with allergic history of drugs, food or other substances;
3. Patients who had undergone surgery within 4 weeks before the trial or planned to undergo surgery during the study period;
4. Subjects who had taken any medicine or health products (including Chinese herbal medicine) within 14 days before the trial;
5. Any drugs (such as: inducer barbiturates, carbamazepine, phenytoin, glucocorticoid, omeprazole) that inhibit or induce liver metabolism were used within 30 days before the trial; Inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines);
6. Subjects who were treated with topical dermatology drugs within one month before the study;
7. Subjects who have been vaccinated or live attenuated vaccine within one month before the study, or who plan to be vaccinated during the study period;
8. Subjects who participated in any clinical trial and took any clinical trial drug within 3 months before the trial;
9. Subjects who donated blood or lost a large amount of blood (>= 200 ml, excluding female menstrual blood loss), received blood transfusion or used blood products within 3 months before inclusion;
10. Subjects with strong hair on both legs and arms;
11. Subjects of pregnant or lactating women, and subjects who cannot use one or more non drug contraceptives during the trial period;
12. Subjects with special dietary requirements could not follow the same diet;
13. Subjects who drank too much tea, coffee and / or caffeinated beverages (more than 8 cups, 1 cup = 250 ml) every day;
14. Smokers or subjects who smoked more than 5 cigarettes per day three months before the experiment or who could not stop using any tobacco products during the experiment;
15. Alcoholics or regular drinkers within 6 months before the trial, i.e. those who drank more than 14 units of alcohol per week (1 unit = 360 ml beer or 45 ml spirits with 40% alcohol or 150 ml wine) or could not stop using any alcoholic products during the trial;
16. Drug abusers or subjects who used soft drugs (such as marijuana) three months before the trial or hard drugs (such as cocaine, phencyclidine, etc.) one year before the trial;
17. Subjects with abnormal vital signs (systolic blood pressure < 90 mmHg or > 140 mmHg, diastolic blood pressure < 50 mmHg or > 90 mmHg; Heart rate < 50 BPM or > 100 BPM) or abnormal physical examination, ECG and laboratory examination have clinical significance (subject to the judgment of clinical research doctors);
18. Subjects who may not be able to complete the study for other reasons or who the researcher thinks should not be included.

研究实施时间：

Study execute time：

从 From 2021-04-15 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-04-15 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

Group 1

样本量：

 6

Group：

Group 1

Sample size：

干预措施：

T-R

干预措施代码：

Intervention：

T-R

Intervention code：

组别：

Group 2

样本量：

 6

Group：

Group 2

Sample size：

干预措施：

R-T

干预措施代码：

Intervention：

R-T

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖南 

市(区县)：

 长沙 

Country：

China

Province：

Hu'nan

City：

Changsha

单位(医院)：

 中南大学湘雅三医院临床试验研究中心 

单位级别：

 三级甲等 

Institution
hospital：

Clinical Trial Research Center of Xiangya Third Hospital of Central South University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

血药浓度

指标类型：

主要指标

Outcome：

plasma concentration

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 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）：

本研究采用区组随机方法，组间比例1:1，让每位受试者随机的的进入（T-R）组或(R-T)组。该随机数据具有重现性，所设定的随机数初值种子参数需要保存。 在筛选时，每名受试者将使用筛选号进行识别。筛选号举例为B-DND-K001。试验的第-1天进行随机。按照筛选号从小到大，每名合格的受试者将获得一个试验号。试验号举例为DND-K001。 受试者人数设定为12人，受试者的试验号为：DND-K001~DND-K012。试验每周期给药一次，健康受试者随机分为两组，每组6人，两周期给药序列分别为T-R及R-T，受试者每周期按照随机表给予对应的试验药物。在第一周期给药前脱落的受试者可进行替补。

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

This study adopts a block randomization method with a 1:1 inter-group ratio, allowing each subject to randomly enter the (T-R) group or (R-T) group. The random data is reproducible, and the set initial seed parameter of the random number needs to be saved. During screening, each subject will be identified

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

是Yes

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）：

文章发表

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

Articles published

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：

电子病例报告表（eCRF）：数据管理员根据试验方案设计构建，并根据逻辑核查计划（DVP）设置逻辑核查，通过测试并获申办方批准后发布使用。 数据录入：原始数据由研究中心指定接受过数据录入培训的人员录入至 EDC 中，或由Ⅰ期临床试验管理系统导出数据包，再通过数据匹配导入至 EDC 中。对于入组受试者需收集 EDC 中要求的全部数据；对于参加了筛选体检但未入组的志愿者，可仅收集知情同意书签署时间、筛选号、人口学资料及排除原因至 EDC 中。 源数据现场核查（SDV）：监查员进行eCRF数据与源数据的一致性核对，有问题可发疑问。 数据疑问和解答：疑问来源于EDC逻辑核查的系统疑问，监查员、数据管理员等人工疑问，研究者需及时解答疑问。数据管理员和监查员进行疑问批复，必要时可再次发出疑问，直至数据“清洁”。 研究者签名：数据录入完成并经CRA SDV与数据管理人员的数据清理、审核完毕后，研究者确认eCRF中数据无误后进行电子签名审核确认。签名后的数据如有修订，需重新签名。 数据库锁定：由主要研究者、申办者、统计分析人员和数据管理人员共同签署数据库锁定记录后，数据管理员进行数据库锁定。 数据库提交：数据管理员向统计人员提交数据库。 eCRF存档：每个受试者的eCRF生成PDF电子文档保存。 数据管理报告：数据管理报告由数据管理人员在数据库锁定后开始撰写，并经各方审核后定稿。 EDC关闭：统计分析完成后，数据管理员关闭数据库。

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

Electronic case report form (eCRF): The data manager is designed and constructed according to the trial plan, and set up a logical verification according to the logical verification plan (DVP), and will be released for use after passing the test and being approved by the sponsor. Data entry: The original data is entered into the EDC by personnel designated by the research center who have received data entry training, or the data package is exported from the phase I clinical trial management system, and then imported into the EDC through data matching. For the enrolled subjects, all data required in the EDC shall be collected; for volunteers who have participated in the screening physical examination but have not been enrolled, only the time of signing the informed consent form, screening number, demographic data and exclusion reasons can be collected into the EDC. Source Data Field Verification (SDV): Inspectors check the consistency of the eCRF data and the source data. Questions can be raised if there is any problem. Data questions and answers: The questions come from the system questions of the EDC logic verification, and the supervisors, data administrators and other manual questions, the researcher needs to answer the questions in time. The data administrator and the inspector will give a reply to the question, and if necessary, the question can be issued again until the data is “clean”. Investigator’s signature: After data entry is completed and the data is cleaned and reviewed by CRA SDV and data management personnel, the researcher confirms that the data in the eCRF is correct and then conducts an electronic signature review and confirmation. If the signed data is revised, it needs to be re-signed. Database lock: After the main researcher, sponsor, statistical analyst and data manager jointly sign the database lock record, the data manager will lock the database. Database submission: The data administrator submits the database to the statistician. eCRF archiving: The eCRF of each subject is saved as a PDF electronic file. Data management report: The data management report is written by the data management staff after the database is locked, and is finalized after review by all parties. EDC closed: After the statistical analysis is completed, the data administrator closes the database.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-04-15 09:12:49