ChiCTR2300070693 版本V1.1 版本创建时间2023/05/29 12:46:37 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：

 ChiCTR2300070693 

最近更新日期：

Date of Last Refreshed on：

 2023-04-20 14:51:49 

注册时间：

Date of Registration：

 2023-04-20 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

吡仑帕奈口服混悬液药代动力学及生物等效性研究

Public title：

Pharmacokinetics and Bioequivalence study of perampanel oral suspension in healthy Chinese volunteers

注册题目简写：

English Acronym：

研究课题的正式科学名称：

吡仑帕奈口服混悬液（规格：0.5mg/mL）在中国健康受试者中单次空腹及餐后口服给药的一项单中心、随机、开放、两制剂、两序列、两周期、交叉生物等效性试验

Scientific title：

A single center, randomized, open label, two-formulations, two-sequence, two-period, crossover bioequivalence trial of perampanel oral suspension (strength: 0.5mg/mL) administered orally on a single dosage under fasting and fed conditions in healthy Chinese 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：

李慕鹏 

研究负责人：

韩杨云、樊莲莲 

Applicant：

Li Mupeng 

Study leader：

Han Yangyun,Fan Lian-Lian 

申请注册联系人电话：

Applicant telephone：

 +86 838 2418213

研究负责人电话：

Study leader's
telephone：

+86 838 2418213

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：

 dysyy_gcp@163.com

研究负责人电子邮件：

Study leader's E-mail：

 dysyy_gcp@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：

四川省德阳市泰山北路173号

研究负责人通讯地址：

四川省德阳市泰山北路173号

Applicant address：

173 Taishan North Road, Jingyang district, Deyang, Sichuan, China

Study leader's address：

173 Taishan North Road, Jingyang district, Deyang, Sichuan, 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：

德阳市人民医院

Applicant's institution：

Deyang People's Hospital

研究负责人所在单位：

德阳市人民医院

Affiliation of the Leader：

Deyang People'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：

 2023-01-008-H01

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：

德阳市人民医院临床试验伦理委员会

Name of the ethic committee：

Independent Ethics Committee of of Clinical Trials in Deyang People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-03-16 00:00:00

伦理委员会联系人：

张培雯

Contact Name of the ethic committee：

Zhang Pei-wen

伦理委员会联系地址：

四川省德阳市泰山北路173号

Contact Address of the ethic committee：

173 Taishan North Road, Jingyang district, Deyang, Sichuan, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 838 2312773

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：

德阳市人民医院

Primary sponsor：

Deyang People's Hospital

研究实施负责（组长）单位地址：

四川省德阳市泰山北路173号

Primary sponsor's address：

173 Taishan North Road, Jingyang district, Deyang, Sichuan, 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)：

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：

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

研究疾病：

癫痫部分性发作  

Target disease：

Partial seizure of 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：

主要目的：评价中国健康受试者空腹及餐后条件下单次口服吡仑帕奈口服混悬液（规格：0.5mg/mL，生产厂家：江西科睿药业有限公司）及参比制剂（商品名：卫克泰?，规格：0.5mg/mL，生产厂家：Eisai GmbH）后的药代动力学特点和生物等效性。 次要目的：观察受试制剂和参比制剂在健康受试者体内的安全性。  

Objectives of Study：

Primary purpose: Evaluate the pharmacokinetic characteristics and bioequivalence of a single oral administration of pirenzopanazole oral suspension (Strength: 0.5mg/mL, manufacturer: Jiangxi Kerui Pharmaceutical Co., Ltd) and reference formulation (Brand name: Fycompa ?, Strength: 0.5mg/mL, manufacturer: Eisai GmbH) in Chinese healthy subjects under fasting and postprandial conditions. Secondary purpose: To observe the safety of the test and reference formulations 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：

受试者必须满足以下所有入选标准才可入组本试验： 1）性别：男性或女性健康受试者； 2）年龄：年龄为18~50周岁（包括18周岁和50周岁）； 3）体重：男性受试者不应低于50.0kg，女性受试者不应低于45.0kg，体重指数[BMI=体重（kg）/身高2（m2）]在19.0～26.0kg/m2范围内（包括19.0和26.0）； 4）受试者充分了解试验目的、性质、方法以及可能发生的不良反应，自愿作为受试者，并在任何研究程序开始前签署知情同意书； 5）受试者自签署知情同意书至试验结束后 3 个月内无生育计划、无捐精捐卵计划，且自愿采取有效的避孕措施； 6）受试者能够与研究者作良好的沟通并能够依照研究规定完成研究。 不符合上述任一条件者，不得入选。

Inclusion criteria

Participants must meet all of the following inclusion criteria in order to be included in this trial: 1) Gender: Male or female healthy subjects; 2) Age: 18-50 years old (including 18 and 50 years old); 3) Weight: Male subjects should not be less than 50.0kg, female subjects should not be less than 45.0kg, and the body mass index [BMI=weight (kg)/height 2 (m2)] should be within the range of 19.0 to 26.0kg/m2 (including 19.0 and 26.0); 4) The subjects fully understand the purpose, nature, method, and potential adverse reactions of the experiment, voluntarily act as subjects, and sign an informed consent form before any research procedure begins; 5) The subject has no fertility plan, no sperm or egg donation plan within 3 months after signing the informed consent form and voluntarily adopts effective contraceptive measures; 6) The subjects are able to communicate well with the researchers and complete the study in accordance with the research regulations. Those who do not meet any of the above conditions shall not be selected.

排除标准：

符合下列任意一条标准者将被排除： 1）经临床医师判断有临床意义的异常情况，包括生命体征、体格检查、12导联心电图、CT检查或临床实验室检查等； 2）有心血管系统、内分泌系统、泌尿生殖系统、消化系统（如既往有习惯性便秘、慢性腹泻、慢性胃炎或胃及十二指肠溃疡等）、血液和淋巴系统、呼吸系统、神经系统、精神疾病等系统的严重疾病史或现患有上述系统疾病者； 3）过敏：既往对吡仑帕奈及对吡仑帕奈制剂中任何成分、或者同类药物过敏者；对乳糖过敏者；对其他药物、食物因素过敏者；或易发生皮疹、荨麻疹等过敏症状体质者； 4）既往接受了除阑尾切除术、疝气切开术之外的任何胃肠道手术史（如胃肠切除、胆囊切除等影响药物吸收代谢的手术）或筛选前6个月内接受过重大手术者； 5）首次给药前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-SSRI类抗抑郁药、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)者； 6）首次给药前2周内使用过任何药物（包括处方药、非处方药、维生素补充剂或中草药）、保健品者； 7）首次给药前14天内接种过疫苗者，或计划在试验期间接种疫苗者； 8）药物滥用筛查阳性者，或在过去五年内有药物滥用史，或筛选前3个月内使用过毒品者； 9）对饮食有特殊要求者、不能遵守提供的饮食和相应的规定者 10）有吞咽困难者； 11）不耐受皮肤穿刺，晕血晕针或采血血管条件差者； 12）受试者从事的职业需要进行高空作业、车辆驾驶等对运动协调能力需求较高的活动者； 13）筛选前3个月每日饮用过量（一天8杯以上，1杯=250mL）茶、咖啡、含咖啡因的饮料或富含葡萄柚的饮料或食物者；或研究首次给药前48h内，摄入任何黄嘌呤类（咖啡因、茶碱、可可碱和马黛因）食物或饮料者，包括咖啡、茶、巧克力等，或摄入葡萄柚、火龙果、芒果、柚子、酸橙、杨桃或由其制备的食物或饮料，或剧烈运动者； 14）筛选前6个月内嗜烟（平均每日吸烟量达5支或以上）者；或试验期间不能停止使用任何烟草类产品者； 15）筛选前6个月内每周饮酒量大于14单位酒精（1标准单位等于17.5mL或14g纯酒精，约等于50°白酒35mL或5°啤酒350mL），或酒精呼气筛查阳性者； 16）筛选前3个月内参加过其他临床试验者或计划在本研究期间参加其他临床试验者； 17）筛选前3个月内献血（全血或血液成分）者或失血400mL及以上（女性生理性失血除外）或接受输血或使用血制品者或计划在研究期间献血或血液成分者； 18）女性受试者筛选前14天内发生无保护的性行为，或试验筛选前30天内使用口服避孕药或试验筛选前6个月内使用长效雌激素或孕激素注射剂或埋植片者； 19）女性受试者正处于哺乳期或妊娠期，或妊娠检查阳性者； 研究者认为不适合入组的其他原因或受试者因自身原因退出试验。

Exclusion criteria：

Those who meet any of the following criteria will be excluded: 1) Abnormalities judged by clinicians to be clinically significant, including vital signs, physical examination, 12 lead ECG, CT examination or clinical laboratory examination; 2) Individuals with a history of severe illnesses in the cardiovascular system, endocrine system, urogenital system, digestive system (such as habitual constipation, chronic diarrhea, chronic gastritis, or gastric and duodenal ulcers), blood and lymphatic system, respiratory system, nervous system, psychiatric system, etc., or currently suffering from these systemic diseases; 3) Allergy: Individuals who have previously been allergic to pirenzepine, any components in pirenzepine preparations, or similar drugs; Individuals who are allergic to lactose; Individuals who are allergic to other drugs or food factors; Individuals with a constitution prone to allergic symptoms such as rash and urticaria; 4) Those who have received any previous gastrointestinal surgery except appendectomy and herniotomy (such as gastrointestinal resection, cholecystectomy and other operations that affect absorption and metabolism) or who have undergone major surgery within 6 months before screening; 5) Within 30 days before the first administration, those who have used any drugs that inhibit or induce liver metabolism of drugs (such as inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotic, verapamil, fluoroquinolones, antihistamines); 6) Those who have used any medication (including prescription drugs, over-the-counter drugs, vitamin supplements, or Chinese herbal medicines) or health products within 2 weeks before the first administration; 7) Those who have received the vaccine within 14 days before the first administration, or those who plan to receive the vaccine during the trial period; 8) Those who are positive for drug abuse screening, or have a history of drug abuse within the past five years, or have used drugs within the first three months of screening; 9) Individuals with special dietary requirements, unable to comply with the provided diet and corresponding regulations 10) Individuals with difficulty swallowing; 11) Individuals who are intolerant of skin puncture, dizziness, or poor blood collection vessel conditions; 12) Subjects engaged in occupations that require high-altitude work, vehicle driving, and other activities that require high levels of motor coordination ability; 13) Individuals who consume excessive amounts of tea, coffee, caffeinated beverages, or grapefruit rich beverages or foods daily (8 or more cups per day, 1 cup=250mL) for the first 3 months of screening; Or those who consume any xanthine like (caffeine, theophylline, theobromine, and madeline) foods or beverages, including coffee, tea, chocolate, or those who consume grapefruit, dragon fruit, mango, grapefruit, lime, carambola, or foods or beverages prepared from them within 48 hours before the first administration of the study, or those who exercise vigorously; 14) Those who smoke heavily (with an average daily smoking volume of 5 or more cigarettes) within the first 6 months of screening; Those who cannot stop using any tobacco products during the trial period; 15) Drinking more than 14 units of alcohol per week within 6 months before screening (1 standard unit is equal to 17.5mL or 14g pure alcohol, about equal to 35mL of 50 ° Baijiu or 350mL of 5 ° beer), or alcohol breath screening positive; 16) Individuals who have participated in other clinical trials within the first 3 months of screening or plan to participate in other clinical trials during this study period; 17) Individuals who have donated blood (whole blood or blood components) within the first 3 months of screening, or have lost 400mL or more of blood (excluding female physiological blood loss), or have received blood transfusions or used blood products, or plan to donate blood or blood components during the study period; 18) Female subjects who engage in unprotected sexual activity within 14 days prior to screening, or use oral contraceptives within 30 days prior to screening, or use long-term estrogen or progesterone injections or implants within 6 months prior to screening; 19) Female subjects are currently breastfeeding or pregnant, or those with positive pregnancy tests; Other reasons that the researchers believe are not suitable for enrollment or subjects withdraw from the experiment due to their own reasons.

研究实施时间：

Study execute time：

从 From 2023-04-18 00:00:00至 To 2024-03-16 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-04-18 00:00:00 至 To 2024-03-16 00:00:00

干预措施：

Interventions：

组别：

A组

样本量：

 21

Group：

Group A

Sample size：

干预措施：

餐后：第一周期给予受试制剂，第二周期给予参比制剂

干预措施代码：

Intervention：

Fed condition: the test formulation was given in the first period, and reference formulation was given in the second period

Intervention code：

组别：

B组

样本量：

 21

Group：

Group B

Sample size：

干预措施：

餐后：第一周期给予参比制剂，第二周期给予受试制剂

干预措施代码：

Intervention：

Fed condition: the reference formulation was given in the first period, and test formulation was given in the second period

Intervention code：

组别：

C组

样本量：

 16

Group：

Group C

Sample size：

干预措施：

空腹：第一周期给予受试制剂，第二周期给予参比制剂

干预措施代码：

Intervention：

Fasting condition: the test formulation was given in the first period, and reference formulation was given in the second period

Intervention code：

组别：

D组

样本量：

 16

Group：

Group D

Sample size：

干预措施：

空腹：第一周期给予参比制剂，第二周期给予受试制剂

干预措施代码：

Intervention：

Fasting condition: the reference formulation was given in the first period, and test formulation was given in the second period

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 四川省 

市(区县)：

  

Country：

China

Province：

Sichuan Province

City：

单位(医院)：

 德阳市人民医院 

单位级别：

 三级甲等 

Institution
hospital：

Deyang People's Hospital

Level of the institution：

Third Class A

测量指标：

Outcomes：

指标中文名：

血浆吡仑帕奈浓度

指标类型：

主要指标

Outcome：

Plasma concentration of perampanel

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不良事件

指标类型：

次要指标

Outcome：

adverse event

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

药代动力学参数

指标类型：

主要指标

Outcome：

Pharmacokinetic parameters

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：

正在进行

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）：

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。

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

The subject random allocation table is randomly generated by the statistical unit using SAS (version 9.4 or higher) in a 1:1 ratio in blocks.

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

Blinding：

open

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）：

不共享原始数据。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Raw data is not shared.

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：

由研究者填写纸质CRF记录数据后，将数据录入至EDC的eCRF中。

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

Researchers fill in the paper CRF record data and input the data into the eCRF of EDC.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2023-04-20 14:51:29