中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500106753
最近更新日期： Date of Last Refreshed on：	2025-07-29 17:43:35
注册时间： Date of Registration：	2025-07-29 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	酮洛芬贴剂在中国健康研究参与者的生物等效性试验
Public title：	Bioequivalence Trial of Ketoprofen Patch in Chinese Health Study Participants
注册题目简写：
English Acronym：
研究课题的正式科学名称：	酮洛芬贴剂在中国健康研究参与者的生物等效性试验
Scientific title：	Bioequivalence Trial of Ketoprofen Patch in Chinese Health Study Participants
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：	倪淑欣	研究负责人：	彭文兴
Applicant：	Shuxin Ni	Study leader：	Peng Wenxing
申请注册联系人电话： Applicant telephone：	+86 158 1551 7024	研究负责人电话： Study leader's telephone：	+86 137 5505 6989
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：	x.ni@cms.net.cn	研究负责人电子邮件： Study leader's E-mail：	pwx.csu@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：	深圳市南山区南头街道马家龙社区南山大道 3186 号莲花广场 B 栋 801	研究负责人通讯地址：	湖南省长沙市岳麓区潭州大道一段626号
Applicant address：	801, Building B, Lotus Plaza, 3186 Nanshan Avenue, Majialong Community, Nantou Street, Nanshan District, Shenzhen, China	Study leader's address：	No. 626, Section 1, Tanzhou Avenue, Yuelu 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：	深圳市康哲生物科技有限公司
Applicant's institution：	Shenzhen Kangzhe Biotechnology Co. , Ltd.
研究负责人所在单位：	湖南妇女儿童医院
Affiliation of the Leader：	Hunan Women's and Children's 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：	FE-YX-LS-2025-027-Y	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：	湖南妇女儿童医院医学伦理审查委员会
Name of the ethic committee：	Medical Ethics Review Committee of Hunan Women's and Children's Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2025-07-02 00:00:00
伦理委员会联系人：	付蕾
Contact Name of the ethic committee：	Lei Fu
伦理委员会联系地址：	湖南省长沙市岳麓区潭州大道一段626号
Contact Address of the ethic committee：	No. 626, Section 1, Tanzhou Avenue, Yuelu District, Changsha, Hunan, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 731 8210 7180	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：

湖南妇女儿童医院

Primary sponsor：

Hunan Women's and Children's Hospital

研究实施负责（组长）单位地址：

湖南省长沙市岳麓区潭州大道一段626号

Primary sponsor's address：

No. 626, Section 1, Tanzhou Avenue, Yuelu 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)：	广东	市(区县)：
Country：	China	Province：	Guangdong	City：
单位(医院)：	深圳市康哲生物科技有限公司	具体地址：	深圳市南山区南头街道马家龙社区南山大道 3186 号莲花广场 B 栋 801
Institution hospital：	Shenzhen Kangzhe Biotechnology Co. , Ltd.	Address：	801, Building B, Lotus Plaza, 3186 Nanshan Avenue, Majialong Community, Nantou Street, Nanshan District, Shenzhen

经费或物资来源：

申办方

Source(s) of funding：

Sponsor

研究疾病：

健康研究参与者

Target disease：

Health Study Participants

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：评价深圳市康哲生物科技有限公司提供的酮洛芬贴剂（规格：40 mg/贴（10 cm×14 cm））与久光製薬株式会社持证的酮洛芬贴剂（商品名：Mohrus®；规格：40 mg/贴（10 cm×14 cm））在中国健康研究参与者单剂量给药的生物等效性。次要目的：评价深圳市康哲生物科技有限公司提供的酮洛芬贴剂（规格：40 mg/贴（10 cm×14 cm））与久光製薬株式会社持证的酮洛芬贴剂（商品名：Mohrus®；规格：40 mg/贴（10 cm×14 cm））在中国健康研究参与者单剂量给药的安全性、黏附性及皮肤刺激性。

Objectives of Study：

Primary Objective: To evaluate the bioequivalence of ketoprofen patch (size: 40 mg/patch (10 cm×14 cm)) provided by Shenzhen Kangzhe Biotechnology Co. Ltd. and ketoprofen patch (trade name: Mohrus® ; size: 40 mg/patch (10 cm×14 cm)) licensed by Hisamitsu Sangyo Co. Ltd. when administered as a single dose to Chinese health study participants. Secondary Objective: To evaluate the safety, adhesion and skin irritation of ketoprofen patch (size: 40 mg/patch (10 cm×14 cm)) provided by Shenzhen Kangzhe Bio-technology Co. Ltd. and ketoprofen patch (trade name: Mohrus® ; size: 40 mg/patch (10 cm×14 cm)) licensed by Kugo Manufacturing Co. Ltd. when administered in a single dose in Chinese health study participants.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

排除标准：

1.试验前 90 天内参加过其他临床试验并使用试验药物者；（问诊+联网筛查） 2.对本品任何一种成分过敏或非甾体抗炎药过敏，或对含有噻吩酸、斯洛芬、苯丙酸、羟苯酮、羟苯丙烯的产品（如太阳镜、香水等）过敏，或有特定过敏史者（如荨麻疹、哮喘、湿疹等），或曾经由于贴剂（包括胶带）导致出现可构成临床问题的瘙痒、红斑、湿疹者，或光线过敏症者；（问诊） 3.有阿司匹林哮喘（非甾体抗炎药等诱发的哮喘）的患者或有既往哮喘病史者；（问诊） 4.在拟给药部位存在毛发过多、纹身、湿疹、皮疹、接触性皮炎、干癣、脂溢症、异形痣、疤痕、色素异常、包疖、外伤、开放性创口、油性肤质等皮肤症状或拟给药对称解剖学部位色度差异过大者或过度日晒者；（问诊+体格检查） 5.患有严重皮肤病史（如：银屑病、白癜风、红斑狼疮等）或已知会改变皮肤外观的疾病（如糖尿病、卟啉症等）或有此类疾病既往史者；（问诊） 6.有心血管系统、内分泌系统、泌尿系统、神经系统、血液学、代谢异常、严重影响免疫反应（例如，原发性或获得性免疫缺陷，如 HIV 或艾滋病；过敏性疾病，如过敏反应、哮喘或全身药物反应；肿瘤，如淋巴瘤或白血病；类风湿性关节炎；或系统性红斑狼疮）等病史且研究者认为目前仍有临床意义者；（问诊） 7.有体位性低血压、不能忍受静脉穿刺、晕针或晕血史者；（问诊） 8.试验前 2 周内因各种原因使用过任何药物者（包括中草药、保健品等）；（问诊） 9.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—SSRIs（选择性血清再吸收抑制剂）类抗抑郁药、酮康唑、利托那韦、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）或其他抗胆碱能药物或者其他具有相互作用的药物（双氯芬酸钠、非索非那定等）者；（问诊） 10. 试验前 3 个月内献血或大量失血（≥400mL）；或计划在试验期间/试验结束后 1 个月内献血者；（问诊+联网筛查） 11. 试验前 3 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；（问诊） 12. 药物滥用者或使用研究药物前 1 年内使用过软毒品（如：大麻）或硬毒品（如：可卡因、苯环己哌啶等）者；（问诊） 13. 试验前 3 个月内每日吸烟量多于 5 支者或研究期间不愿停止吸烟者；（问诊） 14. 试验前 6 个月内经常饮酒者，即每周饮酒超过 14 单位酒精（14 单位=8 瓶啤酒（每瓶 500 mL，酒精量以 3.5%计）或 0.5 斤白酒（酒精量以 45%计）或 1.5 瓶葡萄酒（每瓶 750 mL，酒精量以 13%计））或研究期间不愿停止饮酒或任何含酒精的制品；（问诊） 15. 试验前 3 个月内每天饮用过量茶、咖啡或含咖啡因的饮料（8 杯以上，每杯 200 mL）者，或不同意试验期间停止饮用茶、咖啡和/或含咖啡因的饮料者；（问诊） 16. 入住前 72 小时内进食可能影响药物体内代谢的饮食（包括葡萄柚或葡萄柚产品、柚子、橘子、甘蓝类蔬菜、巧克力等）或含黄酮类化合物的食物（如芹菜、豆制品、苹果、李子、葡萄、石榴等）者；（问诊） 17. 任何食物过敏或对饮食有特殊要求，不能遵守统一饮食者；（问诊） 18. 参与者（或其伴侣）研究期间至研究结束后 3 个月内有妊娠计划、捐精捐卵计划，或研究期间不愿意采取一种或一种以上非药物避孕措施（如完全禁欲、避孕环、伴侣结扎等）者；（问诊） 19. 女性参与者为妊娠或哺乳期女性；或在使用研究药物前 2 周内发生非保护性性行为者；（问诊） 20. 使用研究药物前 2 周内接种疫苗或减毒活疫苗，或计划研究期间接种疫苗者；（问诊） 21. 皮肤划痕试验阳性者； 22. 生命体征、体格检查、实验室检查、心电图检查各项检查异常且有临床意义者（以研究医生综合判定为准）； 23. 尿药筛查试验阳性者； 24. 酒精呼气测试结果＞0.0 mg/100 mL 者； 25. 女性血妊娠为阳性者； 26. 参与者可能因为其他原因而不能完成本研究或经研究者判断具有其它原因不宜参加试验者。

Exclusion criteria：

1. Participation in another clinical trial with a test drug within 90 days prior to the trial; (ask for consultation+ network screening) 2. Allergy to any of the components of the product or to non-steroidal anti-inflammatory drugs (NSAIDs), or allergy to products containing thiophenic acid, slofen, phenylpropionic acid, oxybenzone, oxybenzene propene (e.g., sunglasses, perfume, etc.), or a history of a specific allergy (e.g., urticaria, asthma, eczema, etc.), or who have ever had itchiness, erythema, eczema that could constitute a clinical problem due to the application of patches (including tapes), or photosensitization; (ask for consultation) 3. Patients with aspirin asthma (asthma induced by non-steroidal anti-inflammatory drugs, etc.) or those with a previous history of asthma; (ask for consultation) 4. Presence of skin conditions such as excessive hair, tattoos, eczema, rashes, contact dermatitis, lichen planus, seborrhea, alien nevi, scars, pigmentation abnormalities, packs of boils, traumas, open wounds, oily skin texture, etc., or excessive differences in chromaticity of symmetrical anatomical areas of the site of intended administration or excessive sun exposure; (Ask for Consultation+ Physical Examination) 5. History of severe skin disease (e.g., psoriasis, vitiligo, lupus erythematosus, etc.) or diseases known to alter the appearance of the skin (e.g., diabetes mellitus, porphyria, etc.) or a previous history of such diseases; (ask for consultation) 6. A history of cardiovascular, endocrine, urologic, neurologic, hematologic, metabolic abnormalities, conditions that severely affect the immune response (e.g., primary or acquired immunodeficiencies, such as HIV or AIDS; allergic disorders, such as anaphylactic reactions, asthma, or systemic drug reactions; neoplasms, such as lymphomas or leukemias; rheumatoid arthritis; or systemic lupus erythematosus) that, in the opinion of the investigator, are of continuing Those who have clinical significance; (ask for consultation) 7. history of postural hypotension, intolerance of venipuncture, needle or blood sickness; (ask for consultation) 8. Use of any medication for any reason within 2 weeks prior to the trial (including herbs, supplements, etc.); (ask for consultation) 9. Those who have used any drug that inhibits or induces hepatic metabolism of drugs within 30 days prior to the trial (e.g., inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; Inhibitors - SSRIs (selective serum reuptake inhibitors) antidepressants, ketoconazole, ritonavir, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines) or other anticholinergic medications or other medications that have interactions (diclofenac sodium, fexofenadine, etc.) in those who (ask for consultation) 10. Blood donation or significant blood loss (≥400mL) within 3 months prior to the trial; or planning to donate blood during the trial/within 1 month of the trial; (ask for consultation+ network screening) 11. Individuals who have undergone surgery within 3 months prior to the trial that, in the judgment of the investigator, would interfere with the absorption, distribution, metabolism, or excretion of the drug; or who have undergone surgical procedures within 4 weeks prior to the trial; or who plan to undergo surgical procedures during the study period; (ask for consultation) 12. Substance abusers or those who have used soft drugs (e.g., marijuana) or hard drugs (e.g., cocaine, phenylcyclohexylpiperidine, etc.) within 1 year prior to the use of the study drug; (ask for consultation) 13. who smoked more than 5 cigarettes per day in the 3 months prior to the trial or who are unwilling to stop smoking during the study; (ask for consultation) 14. Regular alcohol use in the 6 months prior to the trial, i.e., consumption of more than 14 units of alcohol per week (14 units = 8 bottles of beer (500 mL each at 3.5% alcohol) or 0.5 kg of liquor (45% alcohol) or 1.5 bottles of wine (750 mL each at 13% alcohol)) or unwillingness to stop consuming alcohol or any alcohol-containing products during the study period; (ask for consultation) 15. Consumption of excessive amounts of tea, coffee, or caffeinated beverages (more than 8 cups at 200 mL each) per day during the 3 months prior to the trial, or who do not agree to stop consuming tea, coffee, and/or caffeinated beverages during the trial; (ask for consultation) 16. who have consumed a diet that may affect the internal metabolism of the drug (including grapefruit or grapefruit products, pomelo, oranges, kale vegetables, chocolate, etc.) or flavonoid-containing foods (e.g., celery, soy products, apples, plums, grapes, pomegranates, etc.) within 72 hours prior to the date of admission to the trial(ask for consultation) 17. Any food allergies or special dietary requirements that prevent compliance with the uniform diet; (ask for consultation) 18. Participants (or their partners) who have a pregnancy plan during the study period up to 3 months after the end of the study, a plan to donate sperm and eggs, or who are unwilling to use one or more non-pharmacological contraceptive methods (e.g., total abstinence, contraceptive rings, partner ligation, etc.) during the study period; (ask for consultation) 19. Female participants who are pregnant or breastfeeding; or who have had unprotected sex within 2 weeks prior to the use of study drug; (ask for consultation) 20. Persons who received a vaccine or live attenuated vaccine within 2 weeks prior to administration of the study drug, or who received a vaccine during the planned study; (ask for consultation) 21. Those who have a positive skin scratch test; 22. Those with abnormal and clinically significant vital signs, physical examination, laboratory tests, and electrocardiograms for each test (as determined by the study physician's comprehensive decision); 23. Those with a positive urine drug screening test; 24. Those with an alcohol breath test result > 0.0 mg/100 mL; 25. Those with a positive blood pregnancy in women; 26. Participants who may not be able to complete the study for other reasons or who, in the judgment of the investigator, have other reasons why they should not participate in the trial.

研究实施时间：

Study execute time：

从 From 2025-08-10 00:00:00至 To 2025-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-08-11 00:00:00 至 To 2025-09-10 00:00:00

干预措施：

Interventions：

组别：	T-R	样本量：	15
Group：	T-R	Sample size：	15
干预措施：	第一周期：T制剂，第二周期：R制剂	干预措施代码：
Intervention：	First Period: Formulation T, Second Period: Formulation R	Intervention code：

组别：	R-T	样本量：	15
Group：	T-R	Sample size：	15
干预措施：	第一周期：R制剂，第二周期：T制剂	干预措施代码：
Intervention：	First Period: Formulation R, Second Period: Formulation 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)：
Country：	China	Province：	Hunan Province	City：
单位(医院)：	湖南妇女儿童医院	单位级别：	三甲医院
Institution hospital：	Hunan Women's and Children's Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	药物峰浓度（Cmax）、药物浓度-时间曲线下面积（AUC0-t和AUC0-∞）	指标类型：	主要指标
Outcome：	Peak drug concentration (Cmax), area under the drug concentration-time curve (AUC0-t and AUC0-∞)	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（Tmax）、表观消除半衰期（t1/2）、表观末端消除速率常数（λz）等	指标类型：	次要指标
Outcome：	Time to peak (Tmax), apparent elimination half-life (t1/2), apparent terminal elimination rate constant (λz), etc.	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	安全性评价	指标类型：	副作用指标
Outcome：	Safety evaluation	Type：	Adverse events
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：	全血	组织：
Sample Name：	whole 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	18	岁 years
最大 Max age	NA	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）：

采用区组随机方法，让每名受试者随机分配至T-R组、R-T组。该随机数据具有重现性，由SAS 9.4或更高版本产生的试验随机种子数需要保存。

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

Using block randomization method, each participant was randomly assigned to the T-R group and R-T group. The random data has reproducibility, and the number of trial random seeds generated by SAS 9.4 or higher versions needs to be saved.

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	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：	EDC
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	EDC
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：	2025-07-29 17:43:20