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：	ChiCTR2300073998
最近更新日期： Date of Last Refreshed on：	2023-07-27 09:14:25
注册时间： Date of Registration：	2023-07-27 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	评估氨酚羟考酮缓释片与氨酚羟考酮片在非癌性慢性疼痛患者中的单中心、随机、多次给药比较药代动力学研究
Public title：	To evaluate the single center, randomized, multiple administration comparative pharmacokinetics of paracetamol Oxycodone sustained-release tablets and paracetamol Oxycodone tablets in patients with non cancerous Chronic pain
注册题目简写：
English Acronym：
研究课题的正式科学名称：	评估氨酚羟考酮缓释片与氨酚羟考酮片在非癌性慢性疼痛患者中的单中心、随机、多次给药比较药代动力学研究
Scientific title：	To evaluate the single center, randomized, multiple administration comparative pharmacokinetics of paracetamol Oxycodone sustained-release tablets and paracetamol Oxycodone tablets in patients with non cancerous Chronic pain
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：	张圣婷	研究负责人：	阳国平
Applicant：	Shenting ZHANG	Study leader：	Guoping YANG
申请注册联系人电话： Applicant telephone：	+86 731 8991 8665	研究负责人电话： Study leader's telephone：	+86 731 8991 8665
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：	1456499839@qq.com	研究负责人电子邮件： Study leader's E-mail：	ygp9880@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：	湖南省长沙市岳麓区桐梓坡路138号	研究负责人通讯地址：	湖南省长沙市岳麓区桐梓坡路138号
Applicant address：	138 Tongzipo Road, Yuelu District, Changsha, Hu'nan	Study leader's address：	138 Tongzipo Road, Yuelu District, Changsha, Hu'nan
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：	中南大学湘雅三医院临床试验中心
Applicant's institution：	Clinical Trial Center of the Third Xiangya Hospital of Central South University
研究负责人所在单位：	中南大学湘雅三医院临床试验中心
Affiliation of the Leader：	Clinical Trial Center of the Third Xiangya Hospital of Central South 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：	快23451	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：	中南大学湘雅三医院伦理委员会
Name of the ethic committee：	IRB of theThird Xiangya Hospital of Central South University
伦理委员会批准日期： Date of approved by ethic committee：	2023-07-07 00:00:00
伦理委员会联系人：	王晓敏
Contact Name of the ethic committee：	Wang Xiaomin
伦理委员会联系地址：	湖南省长沙市岳麓区桐梓坡路138号中南大学湘雅三医院伦理委员会
Contact Address of the ethic committee：	138 Tongzipo Road, Yuelu District, Changsha, Hu'nan
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 731 8861 8938	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：

中南大学湘雅三医院临床试验中心

Primary sponsor：

Clinical Trial Center of the Third Xiangya Hospital of Central South University

研究实施负责（组长）单位地址：

湖南省长沙市岳麓区桐梓坡路138号

Primary sponsor's address：

138 Tongzipo Road, Yuelu District, Changsha, Hu'nan

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)：	长沙
Country：	China	Province：	Hunan	City：	Changsha
单位(医院)：	中南大学湘雅三医院	具体地址：	湖南省长沙市岳麓区桐梓坡路138号
Institution hospital：	Third Xiangya Hospital, Central South University	Address：	138 Tongzipo Road, Yuelu District, Changsha, Hu'nan

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：

疼痛

Target disease：

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：

I期临床试验

Study phase：

1

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

在非癌性慢性疼痛患者中： 1、评价氨酚羟考酮缓释片多次给药药代动力学特征； 2、比较氨酚羟考酮缓释片与氨酚羟考酮片多次给药后的药代动力学特征； 3、评价氨酚羟考酮缓释片多次给药后的安全性和耐受性；

Objectives of Study：

In patients with non-cancerous chronic pain: 1. Evaluate the pharmacokinetic characteristics of multiple administration of aminophenol oxycodone sustained-release tablets; 2. Compare the pharmacokinetic characteristics of aminophenol oxycodone sustained-release tablets and aminophenol oxycodone tablets after multiple administrations; 3. To evaluate the safety and tolerability of aminophenol oxycodone sustained-release tablets after multiple administrations;

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

Volunteers must meet all of the following criteria to be selected:
1) Volunteers fully understand the purpose, nature, methods and possible adverse reactions of the trial, volunteer as volunteers, and sign informed consent before the start of any research procedure;
2) Volunteers can communicate well with researchers, and understand and comply with the requirements of this study;
3) volunteers (including male volunteers) who had taken effective contraception within 14 days prior to randomization and were willing to take effective contraception voluntarily during the trial period and within 6 months after the last dose;
4) Male and female volunteers aged 18~50 with a history of non-cancerous chronic pain (regardless of etiology) (including the cut-off value);
5) Numerical Rating Scale (NRS) score ≤4 in the first 24 hours of randomization;
6) stable pain symptoms within 14 days before randomization, and pain symptoms could remain relatively stable throughout the study period predicted according to medical history;
7) Male volunteers weigh no less than 50 kg. Female volunteers weighed at least 45 kg. Body mass index (BMI) = body weight (kg) / height 2 (m2), body mass index in the range of 19.0~26.0 (including critical value);

排除标准：

符合一条或多条下列标准的志愿者将被排除： 1）既往或目前正患有循环系统、内分泌系统、神经系统（眩晕综合征、脑卒中后遗症，包括但不限于呼吸节律异常、偏瘫、失语、肢体感觉异常；其他中枢神经系统疾病如颅内肿瘤、颅脑损伤、任何原因引起的颅内高压等可能影响呼吸中枢的颅内疾病）、消化系统（恶心、呕吐、胃肠梗阻、麻痹性肠梗阻等）、呼吸系统（通气功能不足、SpO2≤95%、支气管哮喘、慢性阻塞性肺疾病、阻塞性睡眠呼吸暂停低通气综合征）、泌尿生殖系统、血液学、免疫学、精神病学及代谢异常等任何临床严重疾病者或能干扰试验结果的任何其他疾病（非癌性慢性疼痛原发病除外）； 2)有药物、食物或其他物质过敏史； 3)随机前4周内接受过外科手术，或计划在研究期间进行外科手术者； 4)随机前7天内服用过任何药物或保健品者（包括中草药）； 5)随机前3个月内参加任何临床试验且服用了任何临床试验药物者； 6)随机前3个月内献血或大量失血（≥200 mL，不包括女性月经期失血）、接受输血或使用血制品者； 7)妊娠或哺乳期妇女，以及志愿者试验期间不能采用一种或一种以上的非药物避孕措施者； 8)对饮食有特殊要求，不能遵守统一饮食者； 9)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； 10)嗜烟者或随机前3个月每日吸烟量多于5支者或试验期间不能停止使用任何烟草类产品者； 11)酗酒者（包括酒精的滥用或成瘾）或随机前6个月内经常饮酒者，即每周饮酒超过14单位酒精（1单位=360 mL啤酒或45 mL酒精量为40%的烈酒或150 mL葡萄酒）或试验期间不能停止使用任何含酒精产品者； 12)药物滥用者（包括药物的滥用或成瘾）或随机前3个月使用过软毒品（如：大麻）或随机前1年服用硬毒品（如：可卡因、苯环己哌啶等）者； 13)生命体征异常者（收缩压<90 mmHg或>140 mmHg，舒张压<60 mmHg或>90 mmHg；脉搏<60 bpm或>100 bpm；呼吸<12次/分或>20次/分；SpO2≤95%；）或体格检查、心电图、实验室检查异常有临床意义（以临床研究医生判断为准）； 14)有体位性低血压、晕针或晕血史或静脉穿刺采血不耐受者； 15)随机前1个月内接种过疫苗或计划在试验期间接种疫苗者； 16)志愿者可能因为其他原因而不能完成本研究或研究者认为不应纳入者

Exclusion criteria：

Volunteers who meet one or more of the following criteria will be excluded: 1)Previous or current circulatory, endocrine, nervous system (vertigo syndrome, stroke sequelae, including but not limited to abnormal respiratory rhythm, hemiplegia, aphasia, limb paresthesia; Other central nervous system diseases such as intracranial tumors, craniocerebral injury, intracranial hypertension from any cause and other intracranial diseases that may affect the respiratory center), digestive system (nausea, vomiting, gastrointestinal obstruction, paralytic intestinal obstruction, etc.), respiratory system (insufficiency of ventilation, SpO2≤95%, bronchial asthma, chronic obstructive pulmonary disease, obstructive sleep apnea-hypopnea syndrome), genitourinary system,Hematology, immunology, psychiatry, metabolic abnormalities and other serious clinical diseases or any other diseases that can interfere with the test results (except the primary non cancerous Chronic pain); 2) Have a history of allergies to drugs, food, or other substances; 3) Those who have undergone surgery within the first 4 weeks of randomization or plan to undergo surgery during the study period; 4) Individuals who have taken any medication or health products (including Chinese herbal medicine) within the first 7 days of randomization; 5) Those who have participated in any clinical trial and taken any clinical trial medication within the first 3 months of randomization; 6) Individuals who donate blood or experience significant blood loss (≥ 200 mL, excluding female menstrual blood loss), receive blood transfusions, or use blood products within the first 3 months of randomization; 7) Pregnant or lactating women, as well as volunteers who are unable to use one or more non pharmacological contraceptive methods during the trial period; 8) Those who have special dietary requirements and cannot follow a unified diet; 9) Drinking excessive amounts of tea, coffee, and/or caffeinated beverages (8 or more cups, 1 cup=250 mL) every day; 10) Smokers or those who smoke more than 5 cigarettes per day in the first 3 months of randomization, or those who cannot stop using any tobacco products during the trial period; 11) Alcoholics (including alcohol abuse or addiction) or those who regularly drink alcohol within the first 6 months of randomization, i.e. those who consume more than 14 units of alcohol per week (1 unit=360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) or cannot stop using any alcoholic products during the trial period; 12) Drug abusers (including drug abuse or addiction) or those who have used soft drugs (such as marijuana) in the first three months of randomization or taken hard drugs (such as cocaine, phencyclidine, etc.) in the first year of randomization; 13) Individuals with abnormal vital signs (systolic blood pressure<90 mmHg or>140 mmHg, diastolic blood pressure<60 mmHg or>90 mmHg; pulse<60 bpm or>100 bpm; breathing<12 times/min or>20 times/min; SpO2 ≤ 95%;) or those with abnormal physical examination, electrocardiogram, or laboratory examination have clinical significance (based on the judgment of the clinical research doctor); 14) People with postural Hypotension, history of needle or blood sickness or intolerance of Venipuncture blood collection; 15) Those who have received vaccines within the first month of randomization or plan to receive vaccines during the trial period; 16)Volunteers may not be able to complete this study due to other reasons or those who the researcher believes should not be included

研究实施时间：

Study execute time：

从 From 2023-07-26 00:00:00至 To 2026-07-27 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2023-07-27 00:00:00 至 To 2025-07-27 00:00:00

干预措施：

Interventions：

组别：	A	样本量：	24
Group：	A	Sample size：	24
干预措施：	给药方案一：第 1 天第0h开始，每次口服2片氨酚羟考酮缓释片5mg/325mg(盐酸羟考酮/对乙酰氨基酚)，每隔12h给药一次，连续给药9次；	干预措施代码：
Intervention：	Dosing regimen 1: Starting from the 0th h on day 1, each oral administration of 2 tablets of oxycodone hydrochloride sustained-release tablets 5mg/325mg (oxycodone hydrochloride/acetaminophen), administered every 12 hours, 9 times continuously;	Intervention code：

组别：	B	样本量：	24
Group：	B	Sample size：	24
干预措施：	给药方案二：第 1 天第0h开始，每次口服1片氨酚羟考酮片5mg/325mg(盐酸羟考酮/对乙酰氨基酚)，每隔6h给药一次，连续给药18次；	干预措施代码：
Intervention：	Dosing regimen 2: starting from the 0th hour on day 1, take 1 tablet of aminophenol oxycodone tablets 5mg/325mg (oxycodone hydrochloride/acetaminophen) orally each time, administered every 6 hours, 18 times continuously;	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)：	长沙
Country：	China	Province：	Hunan	City：	Changsha
单位(医院)：	中南大学湘雅三医院	单位级别：	三甲
Institution hospital：	Third Xiangya Hospital, Central South 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：	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：	达峰时间	指标类型：	主要指标
Outcome：	Tmax	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	不良反应	指标类型：	次要指标
Outcome：	AE	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	体格检查	指标类型：	次要指标
Outcome：	laboratory test	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：

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	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）：

随机表由统计单位采用SAS（9.4或更高版本）产生，随机时志愿者将按照筛选号从小到大获得随机号。采用区组随机化方法，组间比例为1:1，生成随机号及其对应的组别（A组和B组）。随机号为：K001 ~K048。随机化过程中所设定的区组长度、种子数和SAS程序将一同保存在随机化过程记录中，以保证该随机号编码具有可重现性。志愿者在首次给予试验用药品前脱落的，可以采用筛选合格但未入组的志愿者进行替补，替补志愿者随机号T0XX，即T001将替补K001，替补志愿者入选后，根据方案接受和被替补志愿者相同的研究干预措施。

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

The random table is generated by the statistical unit using SAS (9.4 or later), and volunteers will be given random numbers according to the screening number from smallest to largest. The block randomization method was adopted, the ratio between groups was 1:1, and random numbers and their corresponding groups (group A and group B) were generated. The random number is: K001 ~K048. The block length, seed number and SAS program set during the randomization process are saved together in the randomization process record to ensure that the random number encoding is reproducible. Volunteers who shed before the first administration of the investigational drug can be replaced by volunteers who are qualified but not enrolled, and the random number of the substitute volunteers is T0XX, that is, T001 will replace K001, and after the substitute volunteers are selected, they will receive the same research intervention as the substituted volunteers according to the protocol.

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：	未说明
Blinding：	Not stated
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）：	否
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	NO
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：	数据管理员按照研究方案建立研究数据采集系统及数据库，并在志愿者入组前提供上线使用。使用前，所有 EDC 用户需得到足够的培训。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Data Management Plan (DMP): The DMP serves as the guiding document for data management written by the Data Manager (DM) and approved by the sponsor, and the data management efforts will be based on the timing, content, and methodology defined in the DMP.
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：	2023-07-27 09:13:54