ChiCTR2300071972 版本V1.1 版本创建时间2023/07/23 12:40:18 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：

ChiCTR2300071972 

最近更新日期：

Date of Last Refreshed on：

2023-05-30 16:37:30 

注册时间：

Date of Registration：

2023-05-30 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

克立硼罗软膏（规格：30g/支，2%）在中国健康受试者空腹状态下单次局部外用给药的单中心、随机、开放、两制剂、两序列、两周期交叉生物等效性试验

Public title：

Single-center randomized open two-preparation, two-sequence and two-cycle crossover bioequivalence trial of claborol ointment (specification: 30g/2%) given topically in Chinese healthy volunteers on an empty stomach

注册题目简写：

English Acronym：

研究课题的正式科学名称：

克立硼罗软膏（规格：30g/支，2%）在中国健康受试者空腹状态下单次局部外用给药的单中心、随机、开放、两制剂、两序列、两周期交叉生物等效性试验

Scientific title：

Single-center randomized open two-preparation, two-sequence and two-cycle crossover bioequivalence trial of claborol ointment (specification: 30g/2%) given topically in Chinese healthy volunteers on an empty stomach

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：

程玲  

研究负责人：

陈桂玲 

Applicant：

Chen Ling 

Study leader：

Chen GuiLing 

申请注册联系人电话：

Applicant telephone：

+86 199 7970 3637

研究负责人电话：

Study leader's telephone：

+86 183 4311 3983

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：

chengling@qfyy.com.cn

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：

江西省-赣州市-章贡区青峰大道 188 号

研究负责人通讯地址：

浙江省-杭州市-拱墅区东新街道东新路848号

Applicant address：

No. 188 Qingfeng Avenue, Zhanggong District, Ganzhou City, Jiangxi Province

Study leader's address：

No. 848 Dongxin Road, Dongxin Street, Gongshu District, Hangzhou 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：

江西科睿药业有限公司

Applicant's institution：

Jiangxi Kerui Pharmaceutical 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/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2023伦审第(17)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：

2023-04-26 00:00:00

伦理委员会联系人：

管文花

Contact Name of the ethic committee：

Guan WenHua

伦理委员会联系地址：

杭州市拱墅区东新路848号

Contact Address of the ethic committee：

No. 848 Dongxin Road, Dongxin Street, Gongshu District, Hangzhou City, Zhejiang Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 571 5613 1318

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) Hospital

研究实施负责（组长）单位地址：

浙江省-杭州市-拱墅区东新街道东新路848号

Primary sponsor's address：

No. 848 Dongxin Road, Dongxin Street, Gongshu District, Hangzhou 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)：

江西省

市(区县)：

Country：

China

Province：

Jiangxi Province

City：

单位(医院)：

江西科睿药业有限公司

具体地址：

江西省-赣州市-章贡区青峰大道 188 号

Institution
hospital：

Jiangxi Kerui Pharmaceutical Co., Ltd

Address：

No. 188 Qingfeng Avenue, Zhanggong District, Ganzhou City, Jiangxi Province

经费或物资来源：

江西科睿药业有限公司

Source(s) of funding：

Jiangxi Kerui Pharmaceutical Co., Ltd

Target disease：

Atopic dermatitis

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 评价中国健康受试者空腹状态下单次局部外用克立硼罗软膏受试制剂（规格：30g/支，2%，生产厂家：华益泰康药业股份有限公司，江西科睿药业有限公司提供）和参比制剂（商品名：舒坦明?，规格：30g/支，2%，持证商：Anacor Pharmaceuticals, Inc.）的药代动力学特征和生物等效性。 次要研究目的 研究克立硼罗软膏受试制剂（规格：30g/支，2%，生产厂家：华益泰康药业股份有限公司，江西科睿药业有限公司提供）及参比制剂（商品名：舒坦明?，规格：30g/支，2%，持证商：Anacor Pharmaceuticals, Inc.）在健康受试者中的安全性。  

Objectives of Study：

OBJECTIVE to evaluate the pharmacokinetic characteristics and bioequivalence of a single topical clidboron ointment in Chinese healthy subjects on an empty stomach (specification: 30g/tablet 2% manufacturer: provided by Huayi Taikang Pharmaceutical Co., Ltd. Jiangxi Kerui Pharmaceutical Co., Ltd.) and a reference preparation (trade name: Shutanmin ? specification: 30g/tablet 2% licensee: Anacor Pharmaceuticals, Inc.).Objective to study the safety of test preparation (specification: 30g/tablet 2% manufacturer: provided by Huayi Taikang Pharmaceutical Co., Ltd. Jiangxi Kerui Pharmaceutical Co., Ltd.) and reference preparation (trade name: Shutanmin ? specification: 30g/tablet 2% licensee: Anacor Pharmaceuticals, Inc.) 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）愿意自筛选至最后一次研究药物给药后6个月内自愿采取有效避孕措施，具体避孕措施见附录5； 4)年龄为18~50周岁男性和女性受试者（包括18周岁和50周岁）； 5)男性受试者体重不低于50.0 kg，女性受试者体重不低于45.0 kg，体重指数【BMI=体重(kg)/身高2(m2)】在19.0~28.0 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 before the test and fully understand the test contents and possible adverse reactions; 2) Be able to complete the research according to the requirements of the test scheme; 3) Subjects (including partners) are willing to voluntarily take effective contraceptive measures within 6 months from screening to the last study drug administration. See Appendix 5 for specific contraceptive measures; 4) Male and female subjects aged 18 ~ 50 years (including 18 years old and 50 years old); 5) The weight of male subjects is not less than 50.0 kg, and the weight of female subjects is not less than 45.0 kg. The body mass index [BMI= weight (kg)/height 2 (m2)] is in the range of 19.0 ~ 28.0 kg/m2 (including critical value); 6) Physical examination of normal or abnormal vital signs has no clinical significance

排除标准：

1)筛选前3个月内日吸烟量多于5支者，或试验期间不能戒烟者； 2)对试验药品有过敏史，过敏体质（两种或两种以上药物及食物过敏）； 3)有吸毒和/或酗酒史（每周饮用超过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，或者不能保证试验期间放弃饮酒者，或筛选时酒精呼气测试阳性者）； 4)筛选前3个月内献血，或大量失血（≥400 mL）者； 5)患有任何增加出血性风险的疾病，如痔疮、急性胃炎或胃及十二指肠溃疡等； 6)在筛选前28天服用了任何改变肝酶活性的药物；或使用过作用于血管的（血管收缩剂或血管舒张剂）或调节血流的药物（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、以及内含抗组胺药和/或苯丙醇胺或酚妥拉明的非处方咳嗽/感冒药品）； 7)筛选前14天内使用了任何处方药、非处方药、中草药或保健品； 8)筛选前2周内服用过特殊饮食（包括火龙果、芒果、柚子等）或有剧烈运动，或其他影响药物吸收、分布、代谢、排泄等因素者； 9)最近在饮食或运动习惯上有重大变化； 10)在筛选前3个月内使用过研究药品、或参加了药物临床试验； 11)有血管性水肿、皮炎或其他皮肤类疾病者，或研究者认为受试者存在可能影响给药部位评估的皮肤损伤或异常，例如纹身、胎记、荨麻疹等； 12)筛选前 28 天内背部皮肤使用了外用皮肤科药物治疗者； 13)皮肤过于干燥起皮者，皮肤存在粉刺、痤疮者； 14)临床实验室检查或12导联心电图异常有临床意义； 15)女性受试者在筛选期或试验过程中正处于哺乳期或妊娠期，或血妊娠检查阳性者； 16)筛选前12个月内已知有研究者认为具有临床意义或影响研究的严重疾病（包括但不限于胃肠道、肾、肝、神经、血液、内分泌、肿瘤、肺、免疫、精神或心脑血管疾病）； 17)筛选时乙肝表面抗原、丙型肝炎病毒抗体、丙型肝炎病毒核心抗原、人免疫缺陷病毒抗原抗体联合检测、梅毒螺旋体特异性抗体测定有一项及以上阳性者； 18)在研究前筛选阶段或研究用药前发生急性疾病； 19)在使用研究药物前24 h内摄取了巧克力、任何含咖啡因、或含黄嘌呤食物或饮料； 20)在使用研究用药前24 h内服用过任何含酒精的制品； 21) 酒精及毒品筛查阳性者或在过去五年内有药物滥用史或试验前3个月使用过毒品者； 22）研究者认为受试者不适合参加试验。

Exclusion criteria：

1) Screening those who smoke more than 5 cigarettes per day in the first 3 months or cannot quit smoking during the trial period; 2) Allergic constitution with allergic history to test drugs (allergic to two or more drugs and food); 3) A history of drug abuse and/or alcoholism (drinking more than 14 units of alcohol per week: 1 unit = 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine, or those who can't guarantee to give up drinking during the test or have a positive alcohol breath test at the time of screening); 4) Those who donated blood or lost a lot of blood (≥ 400 mL) within 3 months before screening; 5) Diseases at any risk, such as hemorrhoids, acute gastritis or gastric and duodenal ulcers; 6) Any drug that alters liver enzyme activity was taken 28 days before screening; Or have used drugs that act on blood vessels (vasoconstrictors or vasodilators) or regulate blood flow (such as antihypertensive drugs, antihistamines, non-steroidal anti-inflammatory drugs, aspirin and over-the-counter cough/cold drugs containing antihistamines and/or phenylpropanolamine or phentolamine); 7) Any prescription drugs, over-the-counter Chinese herbal medicines or health products were used within 14 days before screening; 8) Those who have taken special diet (including dragon fruit, mango and grapefruit, etc.) or have exercise or other factors affecting drug absorption, distribution and metabolism within 2 weeks before screening; 9) There have been significant changes in diet or exercise habits recently; 10) Have used research drugs or participated in drug clinical trials within 3 months before screening; 11) People with angioedema dermatitis or other skin diseases or researchers believe that the subjects have skin injuries or abnormalities that may affect the evaluation of the administration site, such as tattoos, birthmarks and urticaria; 12) Those who have been treated with external dermatological drugs for their back skin within 28 days before screening; 13) The skin is too dry and peeling, and the skin has acne and acne; 14) Clinical laboratory examination or 12-lead electrocardiogram abnormality has clinical significance; 15) Female subjects are in lactation or pregnancy or positive blood pregnancy test during screening period or test; 16) Within 12 months before screening, there are known serious diseases (including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, tumor, lung immune spirit or cardiovascular and cerebrovascular diseases) that researchers think have clinical significance or affect the study; 17) When screening, there are one or more positive specific antibodies for combined detection of hepatitis B surface antigen, hepatitis C virus antibody, hepatitis C virus core antigen and human immunodeficiency virus antigen and antibody; 18) Acute disease occurs at the pre-study screening stage or before the study; 19) Chocolate, any food or beverage containing caffeine or xanthine within 24 hours prior to the use of the study drug; 20) Have taken any alcoholic products within 24 hours before the use study; 21) Those who are positive for alcohol and drug screening or have a history of drug abuse in the past five years or have used drugs three months before the test; 22) The researcher thought that the subjects were unfit to participate in the experiment

研究实施时间：

Study execute time：

从 From 2023-06-01 00:00:00至 To 2024-06-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-06-01 00:00:00 至 To 2023-07-31 00:00:00  

干预措施：

Interventions：

组别：

TR组

样本量：

14

Group：

Group TR

Sample size：

干预措施：

第一周期受试者在空腹状态下涂抹受试制剂。4天后交叉给药进入第二周期。

干预措施代码：

Intervention：

In the first cycle, the subject applied the test preparation on an empty stomach;The second cycle of cross administration after 4 days

Intervention code：

组别：

RT组

样本量：

14

Group：

Group RT

Sample size：

干预措施：

第一周期受试者在空腹状态下涂抹参比制剂。4天后交叉给药进入第二周期。

干预措施代码：

Intervention：

In the first cycle, the subject applied the reference preparation on an empty stomach;The second cycle of cross administration after 4 days

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江省 

市(区县)：

  

Country：

China 

Province：

Zhejiang Province 

City：

 

单位(医院)：

树兰（杭州）医院 

单位级别：

三甲 

Institution
hospital：

Shulan(HangZhou) Hospital

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 50 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）：

本研究采取随机、开放、两制剂、两序列、两周期交叉设计。受试者随机分配表由统计单位应用SAS（9.4或更高版本）按1:1比例以区组随机产生。入选受试者随机分为两组。在研究中每名受试者接受受试制剂或参比制剂的顺序将由随机表确定。参加试验的受试者按照签署知情同意书的先后顺序依次给予“筛选号”。在筛选时，每名受试者将使用筛选号S001，S002….进行识别，试验的第-1天进行随机，合格的受试者按男女分开随机，每名受试者将按照筛选号由小到大的顺序获得一个随机号（K001~K028），获得随机号的受试者，则表明该受试者已经纳入研究。

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

In this study, a randomized open two-preparation, two-sequence and two-cycle crossover design was adopted The Subject Random Assignment Table was randomly generated by statistical units using SAS (version 9.4 or higher) in blocks on a 1: 1 ratio The selected subjects were randomly divided into two groups In the study, the order in which each subject receives the test preparation or reference preparation will be determined by a random table The subjects who participated in the experiment were given "screening number" in turn according to the order of signing the informed consent form When screening, each subject will use the screening number S001S002 …. On the first day of the identification test, eligible subjects were randomized separately according to male and female, and each subject was randomized according to the order of screening number from small to large. A subject with random number (K001 ~ K028) indicated that the subject had been included in the study

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：

无

Blinding：

None

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）：

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：

病例记录表、电子采集和管理系统

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

Case Record Form and Electronic Data Capture

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2023-05-30 16:37:23