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苯巴那酯片人体生物等效性研究
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注册号：

Registration number：

 ChiCTR2500100305 

最近更新日期：

Date of Last Refreshed on：

 2025-04-07 17:49:11 

注册时间：

Date of Registration：

 2025-04-07 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

苯巴那酯片人体生物等效性研究

Public title：

Bioequivalence study of phenbenzamide tablets in humans

注册题目简写：

English Acronym：

研究课题的正式科学名称：

苯巴那酯片人体生物等效性研究

Scientific title：

Bioequivalence study of phenbenzamide tablets in humans

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：

梁海秋 

研究负责人：

梁海秋 

Applicant：

Liang Haiqiu 

Study leader：

Liang Haiqiu 

申请注册联系人电话：

Applicant telephone：

 +86 13762810913

研究负责人电话：

Study leader's
telephone：

+86 738 8611061

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：

 258657959@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 258657959@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：

湖南省娄底市娄星区碧溪路娄底市第一人民医院

研究负责人通讯地址：

娄底市娄星区碧溪路

Applicant address：

Loudi First People's Hospital, Bixi Road, Louxing District, Loudi City, Hunan Province

Study leader's address：

Loudi Louxing District

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：

娄底市第一人民医院

Applicant's institution：

The First People's Hospital of Loudi City

研究负责人所在单位：

娄底市第一人民医院

Affiliation of the Leader：

The First People's Hospital of Loudi City

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：

 会娄底市第一人民 YYLL-202503-Y2

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：

娄底市第一人民医院医学伦理委员会

Name of the ethic committee：

Loudi City First People's Hospital Medical Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-03-05 00:00:00

伦理委员会联系人：

李建钢

Contact Name of the ethic committee：

Li Jiangang

伦理委员会联系地址：

娄底市娄星区碧溪路

Contact Address of the ethic committee：

Bixi Road, Louxing District, Loudi City

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 738 8662980

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 18373879108@163.com

研究实施负责（组长）单位：

娄底市第一人民医院

Primary sponsor：

The first peoples hospital of loudi

研究实施负责（组长）单位地址：

娄底市娄星区碧溪路

Primary sponsor's address：

Bixi Road, Louxing District, Loudi City

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)：

娄底市第一人民医院

具体地址：

娄底市娄星区碧溪路

Institution
hospital：

The first peoples hospital of loudi

Address：

Bixi Road, Louxing District, Loudi City

经费或物资来源：

长沙都正生物科技股份有限公司

Source(s) of funding：

Changsha Duzheng Biotechnology Co., Ltd

研究疾病：

癫痫  

Target disease：

Epilepsy

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：

本试验旨在研究空腹状态下单次口服重庆莱美药业股份有限公司生产的苯巴那酯片（12.5 mg）的药代动力学特征；以SK Life Science, Inc.持证、生产的苯巴那酯片（XCOPRI®，12.5 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-72h，评价两制剂的人体生物等效性。  

Objectives of Study：

This trial aimed to study the pharmacokinetic characteristics of a single oral dose of benzbromarone tablets (12.5 mg) manufactured byongqing Laimayi Pharmaceutical Co., Ltd. in the fasted state; the benzbromarone tablets (XCOPRI®, 125 mg) manufactured and held by SK Life Science, Inc. were used as the reference formulation, and the pharmacokinetic parameters Cmax and AUC0-72 were compared between the two formulations to evaluate the bioequivalence of the two formulations in humans.

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.（问诊）既往或目前正患有循环系统、内分泌系统、神经系统、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：家族性短QT综合征、癫痫、抑郁、精神病、肝功能不全、肾功能不全、严重出血倾向等）者； 2.（问诊）既往或目前有慢性或活动性消化道疾病如胃肠道穿孔、胃肠道瘘、食管疾病、胃炎、胃肠道溃疡、肠炎、胃食管反流、胰腺炎，活动性胃肠道出血或进行过消化道手术，且研究者认为目前仍有临床意义者；或首次服用研究药物前7天内有消化道症状（腹泻、便秘、恶心、呕吐、排便不规律，或腹泻便秘交替性发作），且研究者认为不宜参加试验者； 3.（问诊）既往出现过任何药物相关性皮疹反应者； 4.（问诊）试验期间有驾驶汽车或操作危险机械者； 5.（问诊）对1种及以上物质有过敏史，或对本品中任何成分过敏者； 6. (History taking) Subjects who have had or currently have visual impairment, vision disorders (excluding normal myopia), diplopia, etc., are considered unsuitable for the trial by the investigator; 7.（问诊）首次服用研究药物前28天内接受过手术，或计划在试验期间进行手术者； 8.（问诊）首次服用研究药物前14天内使用过任何药物（含接种疫苗）或保健品（包括中草药）者； 9.首次服用研究药物前3个月内使用了任何临床试验药物或入组了任何药物/医疗器械临床试验者； 10.（问诊）首次服用研究药物前3个月内献血者或捐献成分血或有输血者，或首次服用研究药物前3个月内失血超过400 mL者； 11.（问诊）不能忍受静脉穿刺和/或有晕血、晕针史者； 12.（问诊）首次服用研究药物前30天内使用过口服避孕药者，或首次服用研究药物前6个月内使用过长效雌激素或孕激素注射剂或埋植剂者； 13.（问诊）首次服用研究药物前14天内有过无保护性行为者（女性），或妊娠期或哺乳期女性； 14.（问诊）研究参与者或其伴侣在整个试验期间不能采取1种或以上非药物避孕措施，或研究结束后6个月内有生育计划或捐精/捐卵计划者； 15.（问诊）对饮食有特殊要求，不能遵守统一饮食者； 16.（问诊）吞咽困难者； 17.（问诊）首次服用研究药物前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，1杯=250 mL）者； 18.（问诊）首次服用研究药物前48小时内，摄入过或计划摄入任何含有咖啡因的食物或饮料（如咖啡、浓茶、巧克力等）或富含黄嘌呤成分的食物（如沙丁鱼、动物肝脏等）或饮料者； 19.（问诊）首次服用研究药物前14天内摄入过或计划摄入葡萄柚或葡萄柚相关的柑橘类水果（如酸橙、柚子）、杨桃、木瓜、石榴或以上水果制品者； 20.（问诊）嗜烟者或首次服用研究药物前3个月内每日吸烟量多于5支者； 21.（问诊）酗酒者或首次服用研究药物前6个月内经常饮酒者，即每周饮酒超过14单位酒精（1单位≈200 mL酒精含量为5%的啤酒或25 mL酒精含量为40%的烈酒或85 mL酒精含量为12%的葡萄酒）； 22.生命体征、体格检查、心电图、实验室检查等研究医生判断异常有临床意义，且经评估参加本试验将增加安全性风险者； 23.酒精测试不合格者或滥用药物筛查阳性者； 24.可能因为其他原因不能完成本试验或研究者认为不应纳入者。

Exclusion criteria：

1. (History taking) Any clinical serious disease or any other disease that can interfere with the trial results such as cardiovascular system, endocrine system, nervous, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities in the past or currently; (e.g. familial short-QT syndrome epilepsy, depression, psychosis, hepatic insufficiency, renal insufficiency, severe bleeding tendency, etc.); 2.(History) Past or current history of chronic or active gastrointestinal disease such as gastrointestinal perforation, gastrointest fistula, esophageal disease, gastritis, gastrointestinal ulcer, enteritis, gastroesophageal reflux, pancreatitis, active gastroestinal bleeding or history of gastrointestinal surgery, and investigator feels that it is still clinically significant at present; or a history of gastrointestinal symptoms (diarrhea constipation, nausea, vomiting, irregularity of defecation, or alternating diarrhea and constipation) within 7 days before the first use of the study drug, and the feels that it is not appropriate to participate in the trial; 3. (History taking) Those who have had any drug-related rash reaction in the past; 4.(History) those who drove a car or operated dangerous machinery during the trial; 5.(History) History of allergy to one or more substances or to any ingredient in this product; 6.(History taking) Subjects who have had or currently have visual impairment, vision disorders (excluding normal myopia), diplopia, etc., are considered unsuitable for the trial by the investigator; 7.(History) those who had surgery within 28 days before the first dose of the study drug or plan to undergo surgery during the trial; 8.(History) Those who have used any medications (including vaccination) or health products (including traditional Chinese medicine) within 14 days before the first use the study drug; 9.Used any clinical trial drug or was enrolled in any drug/medical device clinical trial within 3 months before the first administration of the study drug; 10. (History) Subjects who have donated blood or blood components within 3 months before the first dose of the study drug or had a transfusion or have lost more than 400 mL of blood within 3 months before the first dose of the study drug; 11.(History taking) Persons who cannot tolerate venipuncture and/or have a history of hemophobia, needle phobia; 12. (History) Use of oral contraceptive agents within 30 days prior to the first dose of study drug, or use of long-acting est or progestin-releasing depot injections or implants within 6 months prior to the first dose of study drug; 13. (History) Those who had unprotected sexual behavior within 14 days before the first use of the study drug (females), or who are pregnant or lactating; 14. (Screening) Participants who are unable to take one or more non-hormonal contraceptive measures throughout the trial, or who plan toceive or donate sperm/ovum within 6 months after the end of the trial, or their partner; 15. (History taking) Those with special dietary requirements who cannot comply with a unified diet; 16. (History) Difficulty in swallowing; 17.(History) Those who drank excessive amount of tea, coffee or caffeine-containing beverages (more than 8 cups, 1 cup = 20 mL) on a daily basis within 3 months before the first use of the study drug; 18. (History) Those who have ingested or plan to ingest any food or beverage containing caffeine (e.g., coffee, black tea chocolate, etc.) or rich in xanthine components (e.g., sardines, animal livers, etc.) or beverage within 48 hours before first use of the study drug; 19. (History) use of grapefruit or grapefruit-related citrus fruits (e.g., Seville oranges, pomelos), fruit, papaya, pomegranate, or fruit products of these within 14 days before the first dose of the study drug or plan to consume these; 20. (History) smokers or those who smoked more than 5 cigarettes per day within 3 months before the first dose of the study drug; 21. (History) alcoholics or subjects who regularly drank alcohol within 6 months before the first dose of the study drug, i.e. more 14 units of alcohol per week (1 unit ≈ 200 mL beer at 5% alcohol strength or 25 mL spirits at 40 alcohol strength or 85 mL wine at 12% alcohol strength); 22. Subjects with vital signs, physical examination, electrocardiogram, laboratory tests, etc., which the investigator judges to be abnormal and clinically significant and which will increase the risk of safety if participating in this trial; 23. Those who fail the alcohol test or test positive for drug abuse; 24.Persons who cannot complete the trial for reasons other than those listed above or who the investigator believes should not be enrolled.

研究实施时间：

Study execute time：

从 From 2025-04-07 00:00:00至 To 2026-04-06 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-04-07 00:00:00 至 To 2026-04-06 00:00:00

干预措施：

Interventions：

组别：

I组

样本量：

 13

Group：

Group I

Sample size：

干预措施：

第一周期:研究参与者于给药前1天入住I期临床试验研究中心，给药前禁食至少10 小时。于给药当天早上单次空腹口服受试制剂(T，12.5mg)，240mL常温水送服(药物需完整吞服)。给药前及给药后1小时内禁止饮水，给药 4、10小时后进食标准午餐和晚餐(统一的清淡饮食)。分别于给药前(0h)及给药后10、20、30、40、50min、1、1.25、1.5、1.75、2、2.5、3、3.5、4、6、8、1224、48、72h(共21个)采集静脉血约4mL。于入住时、给药前(0h)及给药后1、4、8、12、24、48、72h测量生命体征，试验过程中记录不良事件以及合并用药。清洗期:16 天。 第二周期:研究参与者于给药前1天入住I期临床试验研究中心，均按随机方案分别服用相应制剂，重复第一周期过程。

干预措施代码：

Intervention：

Cycle 1: Study participants were admitted to the phase I clinical trial research center 1 day before dosing, and fasted for at least 10 hours before dosing. On the morning of the day of administration, the test preparation (T, 12.5mg) was administered orally on an empty stomach and 240mL of room temperature water (the drug should be swallowed completely). It is forbidden to drink water before and within 1 hour after administration, and eat standard lunch and dinner (a uniform light diet) 4 or 10 hours after administration. About 4mL of venous blood was collected before administration (0h) and 10, 20, 30, 40, 50min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 1224, 48, and 72h (a total of 21) after administration. Vital signs were measured at check-in, before dosing (0h) and at 1, 4, 8, 12, 24, 48, and 72h after dosing, and adverse events and concomitant medications were recorded during the trial. Washout period: 16 days. The second cycle: The study participants were admitted to the phase I clinical trial research center 1 day before dosing, and all of them took the corresponding preparations according to the randomized protocol, and repeated the first cycle process.

Intervention code：

组别：

II组

样本量：

 13

Group：

Group II

Sample size：

干预措施：

第一周期:研究参与者于给药前1天入住I期临床试验研究中心，给药前禁食至少10 小时。于给药当天早上单次空腹口服参比制剂(R，12.5mg)，240mL常温水送服(药物需完整吞服)。给药前及给药后1小时内禁止饮水，给药 4、10小时后进食标准午餐和晚餐(统一的清淡饮食)。分别于给药前(0h)及给药后10、20、30、40、50min、1、1.25、1.5、1.75、2、2.5、3、3.5、4、6、8、1224、48、72h(共21个)采集静脉血约4mL。于入住时、给药前(0h)及给药后1、4、8、12、24、48、72h测量生命体征，试验过程中记录不良事件以及合并用药。清洗期:16 天。 第二周期:研究参与者于给药前1天入住I期临床试验研究中心，均按随机方案分别服用相应制剂，重复第一周期过程。

干预措施代码：

Intervention：

Cycle 1: Study participants were admitted to the phase I clinical trial research center 1 day before dosing, and fasted for at least 10 hours before dosing. On the morning of the day of administration, a single oral dose of reference preparation (R, 12.5mg) was taken on an empty stomach with 240mL of room temperature water (the drug should be swallowed completely). It is forbidden to drink water before and within 1 hour after administration, and eat standard lunch and dinner (a uniform light diet) 4 or 10 hours after administration. About 4mL of venous blood was collected before administration (0h) and 10, 20, 30, 40, 50min, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 1224, 48, and 72h (a total of 21) after administration. Vital signs were measured at check-in, before dosing (0h) and at 1, 4, 8, 12, 24, 48, and 72h after dosing, and adverse events and concomitant medications were recorded during the trial. Washout period: 16 days. The second cycle: The study participants were admitted to the phase I clinical trial research center 1 day before dosing, and all of them took the corresponding preparations according to the randomized protocol, and repeated the first cycle process.

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

City：

单位(医院)：

 娄底市第一人民医院 

单位级别：

 三级甲等 

Institution
hospital：

The first peoples hospital of loudi

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

Cmax

指标类型：

主要指标

Outcome：

Cmax

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

AUC0-72h

指标类型：

主要指标

Outcome：

AUC0-72h

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

 其它  

说明

Fate of sample：

0thers  

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）：

通过SAS软件随机

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

Random via SAS software

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：

开放标签

Blinding：

Open-label study

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：

CRF;EDC

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

CRF;EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-04-07 17:49:03
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