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盐酸他喷他多缓释片人体生物等效性研究
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注册号：

Registration number：

 ChiCTR2500097430 

最近更新日期：

Date of Last Refreshed on：

 2025-02-19 11:27:01 

注册时间：

Date of Registration：

 2025-02-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

盐酸他喷他多缓释片人体生物等效性研究

Public title：

Study of human bioequivalence of Tapentadol Hydrochloride Prolonged-Release Tablets

注册题目简写：

English Acronym：

研究课题的正式科学名称：

盐酸他喷他多缓释片人体生物等效性研究

Scientific title：

Study of human bioequivalence of Tapentadol Hydrochloride Prolonged-Release Tablets

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：

张心丹 

研究负责人：

谢志红 /王斌 

Applicant：

Zhang Xindan 

Study leader：

Xie Zhihong/Wang Bin 

申请注册联系人电话：

Applicant telephone：

 +86 173 7183 1233

研究负责人电话：

Study leader's
telephone：

+86 20 34153599

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：

 zhangxindan@renfu.com.cn

研究负责人电子邮件：

Study leader's E-mail：

 xzh0302@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：

湖北省武汉市洪山区当代光谷梦工厂2号楼12楼

研究负责人通讯地址：

广州市海珠区昌岗东路250号

Applicant address：

12th Floor, Building 2, Contemporary Optics Valley Dream Factory, Hongshan District, Wuhan City, Hub

Study leader's address：

250 Changgang East Road, Haizhu District, Guangzhou

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：

宜昌人福药业有限责任公司

Applicant's institution：

Yichang Humanwell Pharmaceutical Co.,Ltd.

研究负责人所在单位：

广州医科大学附属第二医院

Affiliation of the Leader：

Second Affiliated Hospital of Guangzhou 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：

 Y2025-08-01

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：

广州医科大学附属第二医院临床试验伦理委员会

Name of the ethic committee：

Clinical Trial Ethics Committee of the Second Affiliated Hospital of Guangzhou Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-01-21 00:00:00

伦理委员会联系人：

杜潇潇

Contact Name of the ethic committee：

Du Xiaoxiao

伦理委员会联系地址：

广州市海珠区昌岗东路250号

Contact Address of the ethic committee：

250 Changgang East Road, Haizhu District, Guangzhou

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 20 34153599

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 gyeyec@163.com

研究实施负责（组长）单位：

广州医科大学附属第二医院

Primary sponsor：

Second Affiliated Hospital of Guangzhou Medical University

研究实施负责（组长）单位地址：

广州市海珠区昌岗东路250号

Primary sponsor's address：

250 Changgang East Road, Haizhu District, Guangzhou

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖北省

市(区县)：

武汉市

Country：

China

Province：

Hubei Province

City：

Wuhan City

单位(医院)：

宜昌人福药业有限责任公司

具体地址：

湖北省武汉市洪山区当代光谷梦工厂2号楼12楼

Institution
hospital：

Yichang Humanwell Pharmaceutical Co.,Ltd.

Address：

12th Floor, Building 2, Contemporary Optics Valley Dream Factory, Hongshan District, Wuhan City, Hubei Province

经费或物资来源：

宜昌人福药业有限责任公司

Source(s) of funding：

Yichang Humanwell Pharmaceutical Co.,Ltd.

研究疾病：

严重慢性疼痛。  

Target disease：

Severe chronic pain

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：

研究慢性疼痛参与者在空腹和餐后状态下单次口服受试制剂盐酸他喷他多缓释片与参比制剂盐酸他喷他多缓释片（商品名：Palexia®Retard，规格：50mg；持证商：Grünenthal GmbH）的药代动力学，评价空腹和餐后状态口服两制剂的生物等效性。  

Objectives of Study：

A study was conducted on subjects with chronic pain, who were given a single oral dose of test product，Tapentadol Hydrochloride Extended Release Tablets，on an empty stomach and after a meal, compared to the reference product, Tapentadol Hydrochloride Extended Release Tablets; Pharmacokinetic evaluation of two oral formulations on an empty stomach to assess their bioequivalence.

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.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/精神系统、呼吸系统、心脑血管系统、消化系统（任何影响药物吸收的胃肠道疾病史）、血液及淋巴系统、泌尿系统、内分泌系统、免疫系统疾病者； 2.有消化道疾病史，尤其是任何影响药物吸收的胃肠道疾病史者（如胃或小肠切除术、胃或十二指肠溃疡、萎缩性胃炎、胃肠道出血、梗阻、胆囊炎、胆结石等）； 3.有呼吸抑制或呼吸抑制高风险者（如睡眠呼吸暂停综合征、支气管哮喘）、癫痫病史、低血压病史、精神系统疾病（如抑郁症）或长期服用精神类药物者； 4.过去4周内除慢性疼痛原发病外患有其他严重疾病者； 5.不能耐受静脉穿刺者或有晕针史或晕血史者； 6.改良马氏评分＞II级或存在吞咽困难情况者； 7.筛选前3个月内接受过手术或者计划在研究期间进行手术者，及凡接受过会影响药物吸收、分布、代谢、排泄的手术者； 8.在筛选前1个月内使用过或正在使用任何明显影响本试验药物代谢水平者（如单胺氧化酶（MAO）抑制剂、5-羟色胺、去甲肾上腺素再摄取抑制剂（SNRI）、肌肉松弛剂、利尿剂和抗胆碱药等）； 9.在筛选前1个月内使用过明显抑制或诱导葡萄糖醛酸转移酶（UGT）UGT1A6，UGT1A9和UGT2B7同工酶的药物者（包括处方药、非处方药、保健品或中草药产品等，如双氯芬酸、二氟尼柳、吲哚美辛、尼氟灭酸、依法韦仑、螺内酯、黄芩素、黄芪提取物、苯巴比妥、利福平等）； 10.在筛选前14天内服用了任何处方药、任何非处方药、中草药或保健品者； 11.在筛选前7天内使用过阿片类或类阿片类药物者； 12.药物滥用筛查（吗啡，甲基安非他明，氯胺酮，二亚甲基双氧安非他明，四氢大麻酚酸，可卡因）阳性者或在过去五年内有药物滥用史或试验前3个月使用过软毒品（如：大麻）或试验前1年服用硬毒品（如：苯环己哌啶）者； 13.对本品及其辅料中任何成份过敏者（尤其是曾发生支气管痉挛或血管性水肿者），或同类药物（如羟考酮、二氢吗啡酮、吗啡、芬太尼）过敏者，或有特定过敏史（如过敏性哮喘、荨麻疹、湿疹等）或过敏体质者（如对两种或以上药物、食物或花粉过敏；或易发生过敏反应而找不到发病原因）； 14.在筛选前1个月内接受过疫苗接种或计划试验期间接种疫苗者； 15.筛选前3个月内献血包括成分血或大量失血者（>=400 mL），或计划在试验期间献血者； 16.筛选前3个月内入组过其他的药物临床试验并接受临床试验药物者； 17.在筛选前3个月内平均每日吸烟量多于5支者，或试验期间不能停止使用任何烟草类产品者； 18.在筛选前近6个月有酗酒史者（每周饮用14个单位的酒精：1单位=360mL啤酒或45mL酒精量为40%的烈酒或150mL葡萄酒）；或在试验期间不能停止服用任何含酒精的制品，或酒精筛查阳性者； 19.在筛选前3个月内每天饮用过量茶、咖啡和/或富含咖啡因的饮料（8杯以上，1杯=250mL）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； 20.入住前48 h内食用或饮用过火龙果、芒果、柚子、杨桃或由其制备的食物或饮料，或含黄嘌呤、咖啡因或酒精类的食物或饮料（包括巧克力、茶、咖啡、可乐、可可等），或研究者认为有其他影响药物吸收、分布、代谢、排泄的饮食者，或不同意试验期间停止进食上述饮食者； 21.试验期间女性参与者正处在妊娠期或哺乳期者； 22.女性参与者在筛选前近30天内使用口服避孕药者，或近6个月内使用长效雌激素或孕激素注射剂或埋植片者，或在筛选期或临床试验中正处在哺乳期或妊娠检查结果阳性者； 23.经临床医师判断有临床意义的异常情况，包括体格检查、生命体征监测、心电图或临床实验室检查； 24.乙肝表面抗原阳性、丙肝抗体阳性、HIV抗体阳性或梅毒抗体阳性者； 25.餐后组预计不能完成食用高脂高热餐者； 26.乳糖不耐受者； 27.试验期间对饮食有特殊要求者，不能统一饮食者； 28. 给药后48h内不能避免从事需要高度集中注意力作业者（如驾驶、操作机器、高空作业者等）； 29.其他研究者判定不适宜参加的参与者。

Exclusion criteria：

1. Diseases that need to be excluded due to abnormal clinical manifestations that occur or are occurring before screening, including but not limited to neurological/psychiatric system, respiratory system, cardiovascular and cerebrovascular system, digestive system (any history of gastrointestinal diseases that affect drug absorption), blood and lymphatic system, urinary system, endocrine system, and immune system; 2. Those with a history of digestive tract diseases, especially any gastrointestinal diseases that affect drug absorption (such as gastric or small bowel resection, gastric or duodenal ulcer, atrophic gastritis, gastrointestinal bleeding, obstruction, cholecystitis, gallstones, etc.); 3. Those with respiratory depression or high risk of respiratory depression (such as sleep apnea syndrome, bronchial asthma), history of epilepsy, history of hypotension, psychiatric diseases (such as depression) or long-term use of psychotropic drugs; 4. Those who have other serious diseases in the past 4 weeks except for the primary chronic pain disease; 5. Those who cannot tolerate venipuncture or have a history of needle sickness or blood sickness; 6. Modified Mahalanobis score > grade II or dysphagia; 7. Those who have undergone surgery within 3 months before screening or plan to undergo surgery during the study period, and those who have undergone surgery that will affect the absorption, distribution, metabolism and excretion of drugs; 8. Those who have used or are using any drug metabolism that significantly affects the level of drug metabolism in this test within 1 month before screening (such as monoamine oxidase (MAO) inhibitors, serotonin, norepinephrine reuptake inhibitors (SNRIs), muscle relaxants, diuretics and anticholinergics, etc.); 9. Those who have used drugs that significantly inhibit or induce glucuronosyltransferase (UGT) UGT1A6, UGT1A9 and UGT2B7 isoenzymes within 1 month before screening (including prescription drugs, over-the-counter drugs, health care products or Chinese herbal products, etc., such as diclofenac, diflunisal, indomethacin, niflufenamic acid, efavirenz, spironolactone, baicalin, astragalus extract, phenobarbital, rifampicin); 10. Those who have taken any prescription drugs, any over-the-counter drugs, Chinese herbal medicines or health care products within 14 days before screening; 11. Those who have used opioids or opioids within 7 days before screening; 12. Those who are positive for drug abuse screening (morphine, methamphetamine, ketamine, dimethylenedioxyamphetamine, tetrahydrocannabinolic acid, cocaine) or have a history of drug abuse in the past five years or have used soft drugs (such as marijuana) in 3 months before the test or have taken hard drugs (such as phencycline hexidine) in 1 year before the trial; 13. Those who are allergic to any of the ingredients in this product and its excipients (especially those who have had bronchospasm or angioedema), or those who are allergic to similar drugs (such as oxycodone, dihydromorphone, morphine, fentanyl), or those who have a specific history of allergy (such as allergic asthma, urticaria, eczema, etc.) or allergies (such as allergies to two or more drugs, food or pollen; or prone to allergic reactions and no cause can be found); 14. Those who have received vaccination within 1 month before screening or are vaccinated during the planned trial; 15. Blood donation within 3 months before screening, including those who have component blood or large blood loss (>=400 mL), or those who plan to donate blood during the trial; 16. Those who have been enrolled in other drug clinical trials and received clinical trial drugs within 3 months before screening; 17. Those who smoked more than 5 cigarettes per day on average in the 3 months before screening, or those who could not stop using any tobacco products during the trial; 18. Those who have a history of alcoholism in the past 6 months before screening (drinking 14 units of alcohol per week: 1 unit = 360mL of beer or 45mL of spirits with 40% alcohol or 150mL of wine); or those who cannot stop taking any alcohol-containing products during the test, or who have a positive alcohol screen; 19. Those who have consumed excessive amounts of tea, coffee and/or caffeine-rich beverages (more than 8 cups, 1 cup = 250mL) every day within 3 months before screening; or those who do not agree to stop consuming tea, coffee and/or caffeinated beverages during the trial; 20. Those who have eaten or drunk dragon fruit, mango, grapefruit, star fruit or food or drinks prepared by them, or foods or beverages containing xanthines, caffeine or alcohol (including chocolate, tea, coffee, cola, cocoa, etc.) within 48 hours before check-in, or other diets that the investigator believes affect the absorption, distribution, metabolism and excretion of drugs, or those who do not agree to stop eating the above diets during the trial; 21. Female participants who are pregnant or lactating during the trial; 22. Female participants who have used oral contraceptives in the past 30 days before screening, or those who have used long-acting estrogen or progesterone injections or implants in the past 6 months, or who are breastfeeding or have positive pregnancy test results during the screening period or clinical trial; 23. Clinically significant abnormalities judged by clinicians, including physical examination, vital signs monitoring, electrocardiogram or clinical laboratory tests; 24. Those who are positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody; 25. Those who are expected to be unable to complete the consumption of high-fat and high-hot meals in the postprandial group; 26. Lactose intolerant; 27. Those who have special requirements for diet during the test period, and those who cannot have a unified diet; 28. Those who need to concentrate (such as driving, operating machinery, working at height, etc.) cannot be avoided within 48 hours after administration; 29. Other participants who are judged by the investigator to be insuitable to participate.

研究实施时间：

Study execute time：

从 From 2025-01-16 00:00:00至 To 2026-01-16 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-02-19 00:00:00 至 To 2025-04-30 00:00:00

干预措施：

Interventions：

组别：

空腹TR/RT组

样本量：

 32

Group：

Fasting TR/RT group

Sample size：

干预措施：

第一周期，所有参与者隔空空腹至少10h后，在每周期给药当天早晨采集空白血样后开始给药，在空腹状态下按照给药随机表口服受试制剂或参比制剂1片（整片吞服）。7天后进行第二周期研究，第二周期的给药流程同第一周期一致。

干预措施代码：

Intervention：

In the first cycle, all participants were fasted for at least 10 hours, and a blank blood sample was collected on the morning of each cycle of dosing, and 1 tablet of the test preparation or reference preparation (swallowed whole) was taken orally according to the random table of administration in the fasting state. The second cycle of the study was conducted after 7 days, and the dosing schedule of the second cycle was the same as that of the first cycle.

Intervention code：

组别：

餐后TR/RT组

样本量：

 32

Group：

Postprandial TR/RT group

Sample size：

干预措施：

第一周期，所有参与者隔空空腹至少10h后，在每周期给药当天早晨采集空白血样后开始给药，在空腹状态下按照给药随机表口服受试制剂或参比制剂1片（整片吞服）。7天后进行第二周期研究，第二周期的给药流程同第一周期一致。

干预措施代码：

Intervention：

In the first cycle, all participants were fasted for at least 10 hours, and a blank blood sample was collected on the morning of each cycle of dosing, and 1 tablet of the test preparation or reference preparation (swallowed whole) was taken orally according to the random table of administration in the fasting state. The second cycle of the study was conducted after 7 days, and the dosing schedule of the second cycle was the same as that of the first cycle.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

  

Country：

China

Province：

Guangdong

City：

单位(医院)：

 广州医科大学附属第二医院 

单位级别：

 三级甲等 

Institution
hospital：

Second Affiliated Hospital of Guangzhou Medical University

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：

给药前60min内至给药后48 h

测量方法：

检测血浆中药物浓度

Measure time point of outcome：

Within 60 minutes before administration to 48 hours after administration

Measure method：

Detecting drug concentration in plasma

指标中文名：

AUC0-∞

指标类型：

主要指标

Outcome：

AUC0-∞

Type：

Primary indicator

测量时间点：

给药前60min内至给药后48 h

测量方法：

检测血浆中药物浓度

Measure time point of outcome：

Within 60 minutes before administration to 48 hours after administration

Measure method：

Detecting drug concentration in plasma

指标中文名：

AUC0-t

指标类型：

主要指标

Outcome：

AUC0-t

Type：

Primary indicator

测量时间点：

给药前60min内至给药后48 h

测量方法：

检测血浆中药物浓度

Measure time point of outcome：

Within 60 minutes before administration to 48 hours after administration

Measure method：

Detecting drug concentration in plasma

指标中文名：

不良事件/反应

指标类型：

次要指标

Outcome：

AE

Type：

Secondary indicator

测量时间点：

整个试验期间

测量方法：

通过问诊、生命体征监测、体格检查、实验室检查、ECG等检查进行评价

Measure time point of outcome：

Throughout the entire experimental period

Measure method：

Evaluate through examinations such as consultation, vital sign monitoring, physical examination, laboratory tests, ECG, etc

指标中文名：

Tmax

指标类型：

主要指标

Outcome：

Tmax

Type：

Primary indicator

测量时间点：

给药前60min内至给药后48 h

测量方法：

检测血浆中药物浓度

Measure time point of outcome：

Within 60 minutes before administration to 48 hours after administration

Measure method：

Detecting drug concentration in plasma

指标中文名：

t1/2z

指标类型：

主要指标

Outcome：

t1/2z

Type：

Primary indicator

测量时间点：

给药前60min内至给药后48 h

测量方法：

检测血浆中药物浓度

Measure time point of outcome：

Within 60 minutes before administration to 48 hours after administration

Measure method：

Detecting drug concentration in plasma

指标中文名：

AUC_%Extrap

指标类型：

主要指标

Outcome：

AUC_%Extrap

Type：

Primary indicator

测量时间点：

给药前60min内至给药后48 h

测量方法：

检测血浆中药物浓度

Measure time point of outcome：

Within 60 minutes before administration to 48 hours after administration

Measure method：

Detecting drug concentration in plasma

指标中文名：

λz

指标类型：

主要指标

Outcome：

λz

Type：

Primary indicator

测量时间点：

给药前60min内至给药后48 h

测量方法：

检测血浆中药物浓度

Measure time point of outcome：

Within 60 minutes before administration to 48 hours after administration

Measure method：

Detecting drug concentration in plasma

指标中文名：

严重不良事件（SAE）

指标类型：

次要指标

Outcome：

SAE

Type：

Secondary indicator

测量时间点：

整个试验期间

测量方法：

通过问诊、生命体征监测、体格检查、实验室检查、ECG等检查进行评价

Measure time point of outcome：

Throughout the entire experimental period

Measure method：

Evaluate through examinations such as consultation, vital sign monitoring, physical examination, laboratory tests, ECG, etc

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血浆

组织：

Sample Name：

Plasma

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 55 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）：

随机表由统计单位应用SAS（9.4或更高版本）按区组随机产生，组间比例1:1，将参与者随机分配到TR组和RT组。

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

The random table is generated by statistical units using SAS (version 9.4 or higher) to randomly assign participants to the TR group and RT group, with a 1:1 ratio between groups.

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，对评估者隐藏分组

Blinding：

Open-label study with blinded-evaluators

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和EDC

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

CRF and EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-02-19 11:26:54
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