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：	ChiCTR2500110327
最近更新日期： Date of Last Refreshed on：	2025-10-13 08:16:38
注册时间： Date of Registration：	2025-10-13 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	恩他卡朋片在中国健康研究参与者中空腹和餐后状态下随机、开放、单剂量、两序列、四周期、重复交叉生物等效性研究
Public title：	A Randomized, Open-Label, Single-Dose, Two-Sequence, Four-Period, Replicate Crossover Bioequivalence Study of Entacapone Tablets in Fasting and Fed States Among Healthy Chinese Participants.
注册题目简写：
English Acronym：
研究课题的正式科学名称：	恩他卡朋片在中国健康研究参与者中空腹和餐后状态下随机、开放、单剂量、两序列、四周期、重复交叉生物等效性研究
Scientific title：	A Randomized, Open-Label, Single-Dose, Two-Sequence, Four-Period, Replicate Crossover Bioequivalence Study of Entacapone Tablets in Fasting and Fed States Among Healthy Chinese 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：	王建欣	研究负责人：	王建欣
Applicant：	Jianxin Wang	Study leader：	Jianxin Wang
申请注册联系人电话： Applicant telephone：	+86 156 3013 5915	研究负责人电话： Study leader's telephone：	+86 156 3013 5915
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：	wjx1561@126.com	研究负责人电子邮件： Study leader's E-mail：	wjx1561@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：	河北省石家庄市东岗路89号	研究负责人通讯地址：	河北省石家庄市东岗路89号
Applicant address：	No. 89 Donggang Road, Shijiazhuang City, Hebei Province	Study leader's address：	No. 89 Donggang Road, Shijiazhuang City, Hebei 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：	河北医科大学第一医院
Applicant's institution：	The First Hospital of Hebei Medical University
研究负责人所在单位：	河北医科大学第一医院
Affiliation of the Leader：	The First Hospital of Hebei Medical 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：	[2025]临审第(974)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：	河北医科大学第一医院伦理委员会
Name of the ethic committee：	Ethics Committee of The First Hospital of Hebei Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2025-08-19 00:00:00
伦理委员会联系人：	杨谦谦/赵玉琦
Contact Name of the ethic committee：	Qianqian Yang/Yuqi Zhao
伦理委员会联系地址：	河北省石家庄市东岗路89号
Contact Address of the ethic committee：	No. 89 Donggang Road, Shijiazhuang City, Hebei Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 311 8715 6679	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：

河北医科大学第一医院

Primary sponsor：

The First Hospital of Hebei Medical University

研究实施负责（组长）单位地址：

河北省石家庄市东岗路89号

Primary sponsor's address：

No. 89 Donggang Road, Shijiazhuang City, Hebei 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)：	河北	市(区县)：	石家庄
Country：	China	Province：	Hebei	City：	Shijiazhuang
单位(医院)：	河北医科大学第一医院	具体地址：	河北省石家庄市东岗路89号
Institution hospital：	The First Hospital of Hebei Medical University	Address：	No. 89 Donggang Road, Shijiazhuang City, Hebei Province

经费或物资来源：

河北龙海药业有限公司

Source(s) of funding：

Hebei Longhai Pharmaceutical Co., Ltd

研究疾病：

帕金森病

Target disease：

Parkinson′s disease

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：

其它

Study phase：

N/A

研究设计：

随机交叉对照

Study design：

Cross-over

研究目的：

主要目的：研究健康研究参与者在空腹和餐后状态下，单次口服恩他卡朋片受试制剂（规格：0.2g，河北龙海药业有限公司）与参比制剂[规格：0.2g，珂丹®，Orion Corporation持证]后，比较两制剂在体内血药浓度及主要药代动力学参数，评价两制剂的生物等效性。次要目的：评价两制剂在健康研究参与者中空腹和餐后状态下的安全性。

Objectives of Study：

Primary Objective: To evaluate the bioequivalence between the test formulation (Specification: 0.2g, manufactured by Hebei Longhai Pharmaceutical Co., Ltd.) and the reference formulation (Specification: 0.2g, Comtan®, marketed by Orion Corporation) of Entacapone Tablets following a single oral dose in healthy study participants under fasting and fed conditions. This will be achieved by comparing the in vivo blood concentration profiles and key pharmacokinetic parameters of the two formulations. Secondary Objective: To assess the safety profiles of both formulations in healthy study participants under fasting and fed conditions.

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.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、血液学、免疫学、精神病学及代谢异常等任何临床严重疾病或能干扰试验结果的任何其他疾病（如：高血压、低血压、恶性神经阻滞综合征、非创伤性横纹肌溶解症、嗜铬细胞瘤、心脏病、肝肾功能不全）者； 2.过敏体质，有两种或两种以上食物或药物过敏史者，或已知对恩他卡朋片及其类似物或其任何一种辅料（微晶纤维素、甘露醇、交联羧甲纤维素钠、氢化植物油、硬脂酸镁、羟丙甲纤维素、聚山梨酯、甘油、蔗糖、红氧化铁、黄氧化铁、二氧化钛等）过敏者； 3.果糖不耐受、葡萄糖-半乳糖吸收障碍（曾发生过喝牛奶腹泻）或蔗糖酶-异麦芽糖酶缺乏者或筛选前30天内有显著不正常/特殊饮食(如节食、低钠饮食）或对饮食有特殊要求，不能接受统一饮食者； 4.不能耐受静脉穿刺者，有晕针晕血史者或静脉采血困难者； 5.有吞咽困难或任何影响药物吸收、代谢的胃肠道疾病史者； 6.筛选前6个月有药物滥用史或使用过毒品（问询）或毒品筛查阳性者； 7.女性研究参与者筛选前处在妊娠期或哺乳期，筛选前1个月内发生无保护性行为，筛选前1个月内使用口服避孕药，筛选前6个月内使用长效雌激素或孕激素注射剂或埋植片； 8.筛选前6个月内存在酗酒史，或试验期间不能停止饮酒者。酗酒的定义为：男性每周饮用14个单位以上的酒精饮料或女性每周饮用7个单位以上的酒精饮料（1单位=360mL啤酒或45mL酒精量为40%的烈酒或150mL葡萄酒）； 9.筛选前3个月内接受过外科手术或计划在试验期间进行手术者，以及凡接受过会影响药物吸收、分布、代谢、排泄的手术者； 10.筛选前3个月内献血或大量失血（>=200mL），接受输血或使用血制品者； 11.筛选前3个月内每日吸烟量>5支或试验期间不能停止使用任何烟草类产品者； 12.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； 13.筛选前1个月内接受过疫苗接种者，或者计划在研究期间进行疫苗接种者； 14.筛选前1个月内服用过任何与本品可能有药物相互作用的药物（地昔帕明、马普替林、文拉法辛、利米特罗、氯丙那林、肾上腺素、去肾上腺素、多巴胺、多巴酚丁胺、α-甲基多巴、阿扑吗啡、帕罗西汀、铁制剂、S-华法林等）者； 15.筛选前14天内服用了任何药物、维生素或保健品者； 16.筛选系统未通过或给药前3个月内参加过其它药物临床试验或器械临床试验； 17.生命体征或体格检查异常有临床意义者；实验室检查[包括血常规、血生化、凝血功能、尿常规、乙肝五项定性、丙肝抗体、梅毒螺旋体测定、艾滋病抗体测定、妊娠检查（仅女性）]，12导联心电图检查，任何项目异常并经研究者判断有临床意义者； 18.从事高空作业、机动车驾驶等伴有危险性机械操作的职业者； 19.服药前48h内食用过柚子、火龙果、芒果等影响代谢酶的水果或相关产品，或摄取了任何含咖啡因的食物或饮品（如茶、巧克力、咖啡）或富含嘌呤（如动物肝脏、香菇）的食物者； 20.服药前48h内服用过任何含酒精的制品，或酒精筛查结果>0mg/100mL者； 21.研究参与者可能因为其他原因而不能依从方案完成本研究或研究者判定不适宜参加者。

Exclusion criteria：

1. Have suffered from or are currently suffering from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities, or any other diseases that can interfere with the test results (e.g. : Those with hypertension, hypotension, malignant nerve block syndrome, non-traumatic rhabdomyolysis, pheochromocytoma, heart disease, and liver or kidney dysfunction; 2. People with allergic constitutions, those with a history of allergies to two or more foods or drugs, or those known to be allergic to Entacapone tablets and their analogues or any of their excipients (microcrystalline cellulose, mannitol, sodium cross-linked carboxymethyl cellulose, hydrogenated vegetable oil, magnesium stearate, hydroxypropyl methylcellulose, polysorbitate, glycerin, sucrose, red iron oxide, yellow iron oxide, titanium dioxide, etc.); 3. Individuals with fructose intolerance, glucose-galactose absorption disorders (who have experienced milk-induced diarrhea before), or sucrase - isomaltase deficiency, or those who have had significantly abnormal or special diets (such as dieting, low-sodium diet) within 30 days prior to screening, or have special dietary requirements and cannot accept a uniform diet; 4. Those who cannot tolerate venipuncture, have a history of fainting at the sight of needles and blood, or have difficulty in venous blood collection; 5. Those with a history of difficulty in swallowing or any gastrointestinal diseases that affect the absorption and metabolism of drugs; 6. Those who have a history of drug abuse or have used drugs (inquired) within the six months prior to screening, or who have tested positive in drug screening; 7. Female research participants who were pregnant or lactating before screening, had unprotected sexual behavior within one month before screening, used oral contraceptives within one month before screening, and used long-acting estrogen or progesterone injections or implants within six months before screening; 8. Those who have a history of alcohol abuse within 6 months prior to screening, or those who cannot stop drinking alcohol during the trial period. Alcohol abuse is defined as: men consuming more than 14 units of alcoholic beverages per week or women consuming more than 7 units of alcoholic beverages per week (1 unit =360mL of beer or 45mL of 40% alcohol or 150 ml of wine). 9. Those who have undergone surgical operations within the three months prior to screening or are planning to undergo surgery during the trial period, as well as those who have undergone surgeries that may affect drug absorption, distribution, metabolism, or excretion; 10. Those who have donated blood or lost a large amount of blood (>=200mL) within 3 months prior to screening, received blood transfusion or used blood products; 11. Those who smoked more than 5 cigarettes per day within the 3 months prior to screening or were unable to stop using any tobacco products during the trial period; 12. Those who consumed excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250 mL) every day within the three months prior to screening; 13. Those who have received vaccination within one month prior to screening, or those who plan to receive vaccination during the study period; 14. Those who have taken any drugs that may have drug interactions with this product within one month prior to the screening (such as desipamine, maputelin, venlafaxine, limitro, cloponalin, epinephrine, norepinephrine, dopamine, dobutamine, α -methyldopa, apopmorphine, paroxetine, iron preparations, S-warfarin, etc.); 15. Those who have taken any medication, vitamins or health supplements within 14 days prior to the screening; 16. Failed the screening system or participated in other drug clinical trials or device clinical trials within 3 months before administration; 17. Those with clinically significant abnormalities in vital signs or physical examination; Laboratory tests [including blood routine, blood biochemistry, coagulation function, urine routine, five qualitative hepatitis B tests, hepatitis C antibody, Treponema pallidum determination, AIDS antibody determination, pregnancy test (for females only)], 12-lead electrocardiogram examination, if any item is abnormal and determined by the researcher to have clinical significance; 18. Professionals engaged in high-altitude work, motor vehicle driving and other operations involving dangerous machinery; 19. Those who have consumed fruits or related products that affect metabolic enzymes, such as pomelo, pitaya, or mango, or have taken in any foods or beverages containing caffeine (such as tea, chocolate, or coffee) or foods rich in purine (such as animal liver or mushrooms) within 48 hours before taking the medicine; 20. Those who have taken any alcoholic products within 48 hours before taking the medicine, or whose alcohol screening results are greater than 0mg/100mL; 21. Research participants may be unable to complete this study in accordance with the protocol for other reasons or the researchers may determine that they are not suitable to participate.

研究实施时间：

Study execute time：

从 From 2025-10-09 00:00:00至 To 2026-04-09 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-10-13 00:00:00 至 To 2026-04-09 00:00:00

干预措施：

Interventions：

组别：	T-R-T-R空腹组	样本量：	15
Group：	T-R-T-R fast group	Sample size：	15
干预措施：	受试者在空腹状态下，第一周期口服0.2g（1片）受试制剂，第二周期口服0.2g（1片）参比制剂，第三周期口服0.2g（1片）受试制剂，第四周期口服0.2g（1片）参比制剂。	干预措施代码：
Intervention：	Under fasting conditions, subjects were orally administered the test formulation (0.2g/1 tablet) in Cycle 1, followed by the reference formulation (0.2g/1 tablet) in Cycle 2, the test formulation again (0.2g/1 tablet) in Cycle 3, and finally the reference formulation (0.2g/1 tablet) in Cycle 4.	Intervention code：

组别：	R-T-R-T空腹组	样本量：	15
Group：	R-T-R-T fast group	Sample size：	15
干预措施：	受试者在空腹状态下，第一周期口服0.2g（1片）参比制剂，第二周期口服0.2g（1片）受试制剂，第三周期口服0.2g（1片）参比制剂，第四周期口服0.2g（1片）受试制剂。	干预措施代码：
Intervention：	Under fasting conditions, subjects were orally administered the reference formulation (0.2g/1 tablet) in Cycle 1, followed by the test formulation (0.2g/1 tablet) in Cycle 2, the reference formulation again (0.2g/1 tablet) in Cycle 3, and finally the test formulation (0.2g/1 tablet) in Cycle 4.	Intervention code：

组别：	T-R-T-R高脂餐后组	样本量：	15
Group：	T-R-T-R fed group	Sample size：	15
干预措施：	受试者在高脂餐后给药，第一周期口服0.2g（1片）受试制剂，第二周期口服0.2g（1片）参比制剂，第三周期口服0.2g（1片）受试制剂，第四周期口服0.2g（1片）参比制剂。	干预措施代码：
Intervention：	Under standardized high-fat meal conditions,subjects were orally administered the test formulation (0.2g/1 tablet) in Cycle 1, followed by the reference formulation (0.2g/1 tablet) in Cycle 2, the test formulation again (0.2g/1 tablet) in Cycle 3, and finally the reference formulation (0.2g/1 tablet) in Cycle 4.	Intervention code：

组别：	R-T-R-T高脂餐后组	样本量：	15
Group：	R-T-R-T fed group	Sample size：	15
干预措施：	受试者在高脂餐后给药，第一周期口服0.2g（1片）参比制剂，第二周期口服0.2g（1片）受试制剂，第三周期口服0.2g（1片）参比制剂，第四周期口服0.2g（1片）受试制剂。	干预措施代码：
Intervention：	Under standardized high-fat meal conditions,subjects were orally administered the reference formulation (0.2g/1 tablet) in Cycle 1, followed by the test formulation (0.2g/1 tablet) in Cycle 2, the reference formulation again (0.2g/1 tablet) in Cycle 3, and finally the test formulation (0.2g/1 tablet) in Cycle 4.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	河北	市(区县)：	石家庄
Country：	China	Province：	Hebei	City：	Shijiazhuang
单位(医院)：	河北医科大学第一医院	单位级别：	三甲
Institution hospital：	The First Hospital of Hebei Medical University	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：	从0时到最后一个浓度可准确测定的样品采集时间t的血药浓度-时间曲线下面积	指标类型：	主要指标
Outcome：	AUC0-t, Area under the concentration-time curve from zero to the last measurable 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：	从0时到无限时间(∞)的血药浓度-时间曲线下面积	指标类型：	主要指标
Outcome：	AUC0-∞, Area under the concentration-time curve from zero to infinity	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	达峰浓度的时间	指标类型：	次要指标
Outcome：	Time to peak concentration	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：	次要指标
Outcome：	Elimination rate constant	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：	Terminal elimination 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：	残留面积百分比	指标类型：	次要指标
Outcome：	Percentage of residual area	Type：	Secondary 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		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）：

在研究中每名研究参与者接受受试制剂或参比制剂的顺序将由随机表确定，随机表由统计单位应用SAS（9.4或更高版本）随机产生。

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

During the study, the sequence in which each participant receives the test formulation or the reference formulation will be determined by a randomization schedule. This schedule will be generated by the statistics unit using SAS (version 9.4 or higher).

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：

本次临床研究为开放性研究，除生物样品检测人员外，其他人员如临床研究者、项目管理人员、项目监查人员、统计分析人员等均不设盲。生物样品检测人员将采用盲态分析，在样品分析过程中不知道研究参与者的给药制剂。

Blinding：

This clinical study is an open-label trial. All personnel, including clinical investigators, project management staff, monitors, and statistical analysts, will remain unblinded except for the bioanalytical laboratory personnel. The bioanalytical team will perform blinded analyses, meaning they will have no knowledge of the assigned formulation (test or reference) for each participant's samples during the assay process.

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（EDC）
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	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：	2025-10-13 08:16:33