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：	ChiCTR2500103858
最近更新日期： Date of Last Refreshed on：	2025-06-06 10:22:15
注册时间： Date of Registration：	2025-06-06 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	健康受试者空腹单次口服盐酸替扎尼定片的随机、开放、两序列、两制剂、两周期、交叉设计的生物等效性试验
Public title：	A randomized, open label, two sequence, two formulation, two cycle, crossover design bioequivalence study of single oral administration of Tizanidine Hydrochloride Tablets on an empty stomach in healthy subjects
注册题目简写：
English Acronym：
研究课题的正式科学名称：	健康受试者空腹单次口服盐酸替扎尼定片的随机、开放、两序列、两制剂、两周期、交叉设计的生物等效性试验
Scientific title：	A randomized, open label, two sequence, two formulation, two cycle, crossover design bioequivalence study of single oral administration of Tizanidine Hydrochloride Tablets on an empty stomach 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：	龙岗祥	研究负责人：	徐璐薇
Applicant：	Long Gangxiang	Study leader：	Xu Luwei
申请注册联系人电话： Applicant telephone：	+86 151 1563 7272	研究负责人电话： Study leader's telephone：	+86 150 6100 3175
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：	longgangxiang-hncms@cms.net.cn	研究负责人电子邮件： Study leader's E-mail：	283452112@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：	湖南省常德市澧县临江西路7号	研究负责人通讯地址：	江苏省泰州市海陵区邑庙街6号
Applicant address：	7 Linjiang Road West, Li County, Changde, Hunan	Study leader's address：	No. 6 Yimiao Street, Hailing District, Taizhou City, Jiangsu 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：	康哲(湖南)制药有限公司
Applicant's institution：	Kangzhe (Hunan) Pharmaceutical Co., Ltd.
研究负责人所在单位：	泰州市中医院
Affiliation of the Leader：	Taizhou Traditional Chinese Medicine 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：	2025-032-01	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：	泰州市中医院伦理审查委员会
Name of the ethic committee：	Ethics Review Committee of Taizhou Traditional Chinese Medicine Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2025-05-16 00:00:00
伦理委员会联系人：	刘影
Contact Name of the ethic committee：	Liu Ying
伦理委员会联系地址：	江苏省泰州市海陵区济川东路86号
Contact Address of the ethic committee：	No. 86 Jichuan East Road, Hailing District, Taizhou City, Jiangsu Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 523 8661 1963	伦理委员会联系人邮箱： Contact email of the ethic committee：	tzyiec@126.com

研究实施负责（组长）单位：

泰州市中医院

Primary sponsor：

Taizhou Traditional Chinese Medicine Hospital

研究实施负责（组长）单位地址：

江苏省泰州市海陵区邑庙街6号

Primary sponsor's address：

No. 6 Yimiao Street, Hailing District, Taizhou City, Jiangsu 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)：	湖南	市(区县)：
Country：	China	Province：	Hunan	City：
单位(医院)：	康哲（湖南）制药有限公司	具体地址：	湖南省常德市澧县临江西路7号
Institution hospital：	Kangzhe (Hunan) Pharmaceutical Co., Ltd.	Address：	7 Linjiang Road West, Li County, Changde, Hunan

经费或物资来源：

申办方

Source(s) of funding：

Sponsor

研究疾病：

无

Target disease：

None

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：

试验空腹状态下单次口服受试制剂盐酸替扎尼定片（规格：2 mg，江苏和晨药业有限公司生产）与参比制剂盐酸替扎尼定片（商品名：Sirdalud，规格：2 mg，Novartis Farma S.p.A.生产）在健康成年受试者体内的药代动力学特征，评价空腹状态口服两种制剂的生物等效性。

Objectives of Study：

To evaluate the pharmacokinetic characteristics of the test drug Tizanidine Hydrochloride Tablets (specification: 2 mg, produced by Jiangsu Hechen Pharmaceutical Co., Ltd.) and the reference drug Tizanidine Hydrochloride Tablets (trade name: Sirdalud, specification: 2 mg, produced by Novartis Farma S.p.A.) orally administered on an empty stomach in healthy adult subjects, and to assess the bioequivalence of the two formulations orally administered on an empty stomach.

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. 有特定过敏史者（如哮喘、荨麻疹、湿疹等），或过敏体质者，或已知对本药组分或类似物过敏者； 2. 筛选前发生或正在发生有临床表现异常需排除的疾病，包括但不限于神经/精神、呼吸系统、心脑血管系统、消化道系统（有吞咽困难或任何影响药物吸收的胃肠道疾病史）、血液及淋巴系统、甲状腺、肝肾功能、内分泌系统、免疫系统疾病者； 3. 筛选前接受过经研究医生判定影响药物吸收、分布、代谢和排泄的手术，及试验前3个月内接受过手术或者计划在试验期间进行手术者； 4. 筛选前1个月内服用了任何改变胃肠道环境成份的药物者（如质子泵抑制剂泰妥拉唑、奥美拉唑、兰索拉唑、埃索拉唑等；H2拮抗剂雷尼替丁、西咪替丁、法莫替丁等；抗酸剂碳酸氢钠、氧化镁、氢氧化铝、三硅酸镁等；胃黏膜保护剂硫糖铝等）； 5. 筛选前1个月内服用过CYP1A2 抑制剂（如氟伏沙明、环丙沙星、齐留通、喹诺酮类、胺碘酮、美西律、普罗帕酮、西咪替丁、法莫替丁、口服避孕药、阿昔洛韦和噻氯匹定）者；服用其他肝酶诱导剂（如巴比妥类、卡马西平、苯妥英钠、地塞米松）或抑制剂（如SSRI类抗抑郁药、地尔硫卓、大环内酯类、甲硝唑、酮康唑、维拉帕米、镇静催眠药、抗组胺类等）；或其他与本品有药物相互作用的药物者； 6. 筛选前1个月内服用过中枢神经系统抑制剂（如苯二氮卓类、阿片类药物、三环抗抑郁药等）者。 7. 既往有原发性低血压史者； 8. 筛选前2周内使用过任何处方药、非处方药、中草药或保健品等者； 9. 筛选前3个月内平均每周饮酒量≥14单位（1单位酒精≈285mL啤酒或25mL酒精含量为40%的烈酒或100mL葡萄酒），或试验期间（筛选日至最后一周期出院）不同意或不能停止使用任何酒精类产品者； 10. 筛选前12个月内有药物滥用史、使用过毒品者； 11. 筛选前3个月内服用过其他试验药物，或入组过其他的器械或药物临床试验或非本人来参加临床试验者； 12. 筛选前3个月内献血或大量失血（≥400mL，女性正常生理期失血量除外），或计划在试验期间（筛选日至最后一周期出院）或研究结束后一个月内献血者； 13. 筛选前3个月内接受过疫苗接种或试验结束后一个月内计划接种疫苗者； 14. 筛选前1周内食用过含有可诱导或抑制肝脏代谢酶的食物（如西柚、葡萄柚、酸橙、芒果、火龙果、甘蓝类蔬菜等）及其制备的食物或饮料，或试验期间（筛选日至最后一周期出院）不同意或不能停止食用此类食物或饮料者； 15. 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（平均8杯以上，1杯≈250mL，种类包括巧克力、咖啡、可乐等）者，或试验期间（筛选日至最后一周期出院）不同意或不能停止食用此类食物或饮料者； 16. 对饮食有特殊要求，不能接受统一饮食者；乳糖不耐受者（如喝牛奶腹泻）者；不能进食或存在吞咽困难； 17. 筛选前一个月内已经开始显著不正常的饮食者（如高钾、低脂、节食、低钠等）； 18. 女性受试者正处在哺乳期、妊娠期； 19. 不能耐受静脉穿刺者或有晕针史或晕血史者； 20. 入住前1周内发生过腹泻、呕吐等者； 21. 入住酒精呼气检测结果大于0.0mg/100mL者； 22. 入住药物滥用检测阳性者； 23. 筛选及入住烟碱检查阳性者； 24. 女性受试者自筛选前两周（男性受试者自第一次服药后）至研究药物最后一次服药后6个月内有妊娠计划且不愿采取有效的避孕措施或男性有捐精，女性有捐卵计划者； 25. 研究前2周内一般体格检查、实验室检查，心电图结果经临床医生判断为异常有临床意义者； 26. 研究者认为有其他不适宜参加临床试验或受试者因自身原因不愿意参加试验者。有符合上述条件之一者，不得作为受试者入选。

Exclusion criteria：

1. Individuals with a specific history of allergies (such as asthma, urticaria, eczema, etc.), or those with an allergic constitution, or those known to be allergic to the components or analogues of this drug; 2. Diseases that have occurred or are currently occurring with clinical manifestations that need to be excluded before screening, including but not limited to neurological/psychiatric, respiratory, cardiovascular and cerebrovascular systems, digestive system (with a history of swallowing difficulties or any gastrointestinal diseases that affect drug absorption), blood and lymphatic system, thyroid, liver and kidney function, endocrine system, and immune system diseases; 3. Individuals who have undergone surgery determined by research doctors to affect drug absorption, distribution, metabolism, and excretion prior to screening, as well as those who have undergone surgery within the past 3 months prior to the trial or plan to undergo surgery during the trial period; 4. Individuals who have taken any drugs that alter the composition of the gastrointestinal environment within one month prior to screening (such as proton pump inhibitors such as metronidazole, omeprazole, lansoprazole, esoprazole, etc.; H2 antagonists such as ranitidine, cimetidine, famotidine, etc.); Sodium bicarbonate, magnesium oxide, aluminum hydroxide, magnesium trisilicate and other antacids; Gastric mucosal protectants such as sucralfate 5. Individuals who have taken CYP1A2 inhibitors (such as fluvoxamine, ciprofloxacin, ziluton, quinolones, amiodarone, metoprolol, propafenone, cimetidine, famotidine, oral contraceptives, acyclovir, and clopidogrel) within one month prior to screening; Taking other liver enzyme inducers (such as barbiturates, carbamazepine, phenytoin sodium, dexamethasone) or inhibitors (such as SSRI antidepressants, diltiazem, macrolides, metronidazole, ketoconazole, verapamil, sedative hypnotic drugs, antihistamines, etc.); Or other drugs that interact with this product; 6. Individuals who have taken central nervous system inhibitors (such as benzodiazepines, opioids, tricyclic antidepressants, etc.) within the past month prior to screening. 7. Individuals with a history of primary hypotension; 8. Individuals who have used any prescription drugs, over-the-counter drugs, herbal medicines, or health supplements within the past 2 weeks prior to screening; 9. Individuals who have consumed an average of ≥ 14 units of alcohol per week (1 unit of alcohol ≈ 285mL of beer or 25mL of 40% spirits or 100mL of wine) within the first 3 months of screening, or who do not agree or cannot stop using any alcoholic products during the trial period (from screening date to discharge in the last cycle); 10. Screening for individuals with a history of drug abuse or drug use within the past 12 months; 11. Screening for individuals who have taken other investigational drugs within the previous 3 months, or have been enrolled in clinical trials of other devices or drugs, or who have not participated in clinical trials themselves; 12. Individuals who have donated blood or experienced significant blood loss (≥ 400mL, excluding normal menstrual blood loss in females) within the first 3 months of screening, or who plan to donate blood during the trial period (from screening date to discharge in the last cycle) or within one month after the end of the study; 13. Screening individuals who have received vaccination within the previous 3 months or plan to receive vaccination within one month after the end of the trial; 14. Individuals who have consumed foods containing enzymes that can induce or inhibit liver metabolism (such as grapefruit, grapefruit, lime, mango, dragon fruit, cabbage vegetables, etc.) and their prepared foods or beverages within one week prior to screening, or who do not agree or cannot stop consuming such foods or beverages during the trial period (from screening date to discharge in the last cycle); 15. Individuals who have consumed excessive amounts of tea, coffee, and/or caffeinated beverages (with an average of 8 or more cups, 1 cup ≈ 250mL, including chocolate, coffee, cola, etc.) daily within the past 3 months prior to screening, or those who do not agree or cannot stop consuming such foods or beverages during the trial period (from screening date to final discharge); 16. Those who have special dietary requirements and cannot accept a uniform diet; Lactose intolerant individuals (such as those experiencing diarrhea from drinking milk); Inability to eat or difficulty swallowing; 17. Screening for individuals who have started significantly abnormal eating habits within the previous month (such as high potassium, low-fat, dieting, low sodium, etc.); 18. Female subjects are currently breastfeeding or pregnant; 19. Individuals who cannot tolerate venipuncture or have a history of needle or blood dizziness; 20. Individuals who have experienced diarrhea, vomiting, or other symptoms within one week prior to check-in; 21. Check in alcohol breath test results greater than 0.0mg/100mL; 22. Individuals who have tested positive for drug abuse during their stay; 23. Screening and check-in of individuals with positive nicotine test results; 24. Female participants who have a pregnancy plan within two weeks prior to self screening (from the first dose for male participants) to 6 months after the last dose of the study drug and are unwilling to take effective contraceptive measures, or if male participants have sperm donation plans and female participants have egg donation plans; 25. Individuals who have undergone general physical examinations, laboratory tests, and electrocardiogram results within 2 weeks prior to the study, and whose clinical significance is determined by clinical doctors to be abnormal; 26. Researchers believe that there are other participants who are not suitable to participate in clinical trials or who are unwilling to participate due to their own reasons. Those who meet one of the above conditions shall not be selected as subjects.

研究实施时间：

Study execute time：

从 From 2025-05-16 00:00:00至 To 2025-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-06-15 00:00:00 至 To 2025-07-15 00:00:00

干预措施：

Interventions：

组别：	T-R组	样本量：	19
Group：	T-R group	Sample size：	19
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组	样本量：	19
Group：	R-T group	Sample size：	19
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)：	江苏省	市(区县)：
Country：	China	Province：	Jiangsu	City：
单位(医院)：	泰州市中医院	单位级别：	三甲
Institution hospital：	Taizhou Traditional Chinese Medicine Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	药代动力学	指标类型：	主要指标
Outcome：	Pharmacokinetic	Type：	Primary 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：	主要指标
Outcome：	Safety evaluation	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：

标本中文名：	尿液	组织：
Sample Name：	urine	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	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）：

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:

公开/Public

盲法：	本次临床研究为开放性研究，除生物样本检测人员外，其他人员如临床研究人员、项目管理人员、项目监查人员、数据管理及统计分析人员等均不设盲。生物样本检测人员将采用盲态分析，在样本分析过程中不得获知受试者的服药制剂。
Blinding：	This clinical study is an open label study, and except for biological sample testing personnel, other personnel such as clinical researchers, project management personnel, project monitoring personnel, data management and statistical analysis personnel are not blinded. Biological sample testing personnel will use blind analysis, and during the sample analysis process, they will not be able to obtain information about the subjects' medication preparations.
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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：	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：	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：	2025-06-06 10:21:50