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：	ChiCTR2600123496
最近更新日期： Date of Last Refreshed on：	2026-04-27 15:09:35
注册时间： Date of Registration：	2026-04-27 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	在健康试验参与者中评估利福平胶囊和硫酸氢氯吡格雷片多次给药后对NTQ5082胶囊药代动力学影响的开放、非随机的I期临床研究
Public title：	An open, non-randomized Phase I clinical study to evaluate the effect of multiple administrations of rifampicin capsules and ciprofibrate hydrochloride tablets on the pharmacokinetics of NTQ5082 capsules in healthy trial participants
注册题目简写：
English Acronym：
研究课题的正式科学名称：	在健康试验参与者中评估利福平胶囊和硫酸氢氯吡格雷片多次给药后对NTQ5082胶囊药代动力学影响的开放、非随机的I期临床研究
Scientific title：	An open, non-randomized Phase I clinical study to evaluate the effect of multiple administrations of rifampicin capsules and ciprofibrate hydrochloride tablets on the pharmacokinetics of NTQ5082 capsules in healthy trial 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：	黄洁	研究负责人：	阳国平
Applicant：	Huang Jie	Study leader：	Yang Guoping
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 8938
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：	cellahuang1988@163.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：	中国湖南省长沙市岳麓区桐梓坡路138号	研究负责人通讯地址：	中国湖南省长沙市岳麓区桐梓坡路138号
Applicant address：	No. 138 Tongzipo Road, Yuelu District, Changsha City, Hunan Province, China	Study leader's address：	No. 138 Tongzipo Road, Yuelu District, Changsha City, Hunan Province, 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：	中南大学湘雅三医院临床试验研究中心
Applicant's institution：	Center for Clinical Pharmacology, the Third Xiangya Hospital, 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研究中心
Affiliation of the Leader：	Center for Clinical Pharmacology, the Third Xiangya Hospital, 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：	26065	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：	The Ethics Committee of Xiangya Third Hospital of Central South University
伦理委员会批准日期： Date of approved by ethic committee：	2026-03-19 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：	中国湖南省长沙市岳麓区桐梓坡路138号
Contact Address of the ethic committee：	No. 138 Tongzipo Road, Yuelu District, Changsha City, Hunan Province, China
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 Xiangya Third Hospital of Central South University

研究实施负责（组长）单位地址：

中国湖南省长沙市岳麓区桐梓坡路138号

Primary sponsor's address：

No. 138 Tongzipo Road, Yuelu District, Changsha City, Hunan Province, 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)：	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：	中国湖南省长沙市岳麓区桐梓坡路138号
Institution hospital：	Xiangya Third Hospital of Central South University	Address：	No. 138 Tongzipo Road, Yuelu District, Changsha City, Hunan Province, China

经费或物资来源：

南京正大天晴制药有限公司

Source(s) of funding：

Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd.

研究疾病：

阵发性睡眠性血红蛋白尿症

Target disease：

Paroxysmal nocturnal hemoglobinuria

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：

非随机对照试验

Study design：

Non randomized control

研究目的：

主要目的： 1.评价健康试验参与者多次口服利福平胶囊（CYP2C8和UGT1A1诱导剂）后对NTQ5082胶囊的药代动力学影响。 2.评价健康试验参与者多次口服硫酸氢氯吡格雷片（CYP2C8抑制剂）后对NTQ5082胶囊的药代动力学影响。次要目的： 1.评价单剂量口服NTQ5082胶囊及与利福平胶囊（CYP2C8和UGT1A1诱导剂）联合用药在健康试验参与者中的安全性。 2.评价单剂量口服NTQ5082胶囊及与硫酸氢氯吡格雷片（CYP2C8抑制剂）联合用药在健康试验参与者中的安全性。

Objectives of Study：

Main objective: 1.To evaluate the pharmacokinetic impact of NTQ5082 capsules on healthy trial participants after multiple oral administrations of rifampicin capsules (CYP2C8 and UGT1A1 inducers). 2.To evaluate the pharmacokinetic impact of NTQ5082 capsules on healthy trial participants after multiple oral administrations of ciprofibrate hydrochloride tablets (CYP2C8 inhibitor). Secondary objectives: 1.To evaluate the safety of single-dose oral NTQ5082 capsules and combined use with rifampicin capsules (CYP2C8 and UGT1A1 inducers) in healthy trial participants. 2.To evaluate the safety of single-dose oral NTQ5082 capsules and combined use with ciprofibrate hydrochloride tablets (CYP2C8 inhibitor) in healthy trial participants.

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)入住前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； 2)入住前三年内有慢性或活动性消化道疾病如食管疾病、胃炎、胃溃疡、胃食管反流、肠炎、活动性胃肠道出血或消化道手术者且研究者认为目前仍有临床意义者； 3)有中枢神经系统、心血管系统、消化系统、呼吸系统、内分泌系统、泌尿系统、血液及淋巴系统、代谢障碍等的明确疾病且需要医学干预或其他不适合参加临床试验的疾病（如精神病史等）者； 4)首次给药前14天内有恶心、呕吐、腹泻等症状，且研究者认为不宜参加试验者； 5)已知或疑似免疫缺陷病史（例如，频繁复发性感染病史）、遗传性或后天补体缺乏症史者； 6)入住前6个月内有明确的荚膜微生物感染史者；包括但不限于：肺炎链球菌、炭疽杆菌、沙门氏菌、伤寒沙门氏菌、肺炎克雷伯氏菌、绿脓杆菌、脆弱拟杆菌、脑膜炎奈瑟氏菌、流感嗜血杆菌、嗜肺军团菌感染史等； 7)既往有结核感染病史者或现患有结核感染者； 8)首次给药前14天内出现活动性全身性细菌、病毒或真菌感染者； 9)既往或给药前有活动性病理性出血者，如消化性溃疡或颅内出血； 10)肝功能不全者、肾功能不全者、胆道阻塞者； 11)对试验用药物及其任何成分或相关制剂，或有药物、食物或其他物质过敏史者； 12)不能耐受静脉穿刺或有晕血、晕针史者； 13)入住前6个月内接受过经研究者判断会影响药物吸收、分布、代谢、排泄的手术者；或入住前30天内接受过外科手术；或计划在试验期间进行外科手术者； 14)入住前14天内使用过任何药物者（包括处方药物、非处方药物、中草药、中成药和膳食补充剂等）；或者筛选时在药物5个半衰期以内者（以时间更长者为准）； 15)入住前14天内接种疫苗或减毒活疫苗（脑膜炎球菌疫苗和肺炎链球菌疫苗除外），或计划会在试验期间接种疫苗者； 16)筛选时QTc>=450 msec（男性）或者QTc>=460 msec（女性）者； 17)入住前3个月内献血或大量失血（＞400mL）者，接受输血或使用血制品者，或打算在试验期间或试验结束后3个月内献血或血液成份者； 18)药物滥用者或入住前1年内使用过软毒品（如：大麻）或硬毒品（如：可卡因、苯环己哌啶等）者；或尿毒筛试验阳性者； 19)嗜烟者或入住前3个月内每日吸烟量多于5支者，或试验期间不能停止使用任何烟草类产品； 20)酗酒者或入住前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）；或试验期间不愿意停止饮酒或任何含酒精制品者；或酒精呼气试验阳性者； 21)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，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； 22)入住前7天内进食可能影响药物体内代谢的饮食（包括葡萄柚或葡萄柚产品等），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，或不同意在试验期间停止进食上述饮食者； 23)对饮食有特殊要求，不能遵守统一饮食者； 24)女性试验参与者为妊娠或哺乳期女性；或在入住前14天内发生非保护性性行为者；或入住前30天内使用口服避孕药或入住前6个月内使用长效雌激素或孕激素注射剂或埋植片者； 25)试验参与者（或其伴侣）自签署知情同意书开始至末次给药后3个月内有妊娠计划、捐精捐卵计划，或不愿采取一种或一种以上的非药物避孕措施（如完全禁欲、避孕环、伴侣结扎等）者； 26)体格检查、心电图、腹部B超、胸部正位片、实验室检查（血常规、尿常规、血生化、降钙素原、凝血功能、甲功三项、输血四项、女性血妊娠）、生命体征及各项检查异常有临床意义者（以研究医生判断为准）； 27)酒精呼气测试或药物滥用筛查阳性者； 28)试验参与者可能因为其他原因而不能完成本研究或经研究者判断具有其它不宜参加试验原因者。

Exclusion criteria：

1. Those who participated in any clinical trial within the previous 3 months and took any clinical trial drugs; 2. Those who had chronic or active digestive tract diseases such as esophageal diseases, gastritis, gastric ulcers, gastroesophageal reflux, enteritis, active gastrointestinal bleeding or digestive tract surgery within the previous 3 years, and the investigator believes that it still has clinical significance at present; 3.Those with definite diseases in the central nervous system, cardiovascular system, digestive system, respiratory system, endocrine system, urinary system, blood and lymph system, or metabolic disorders and require medical intervention or other diseases that are not suitable for participating in clinical trials (such as a history of mental illness, etc.); 4. Those who had symptoms such as nausea, vomiting, or diarrhea within 14 days before the first administration, and the investigator believes that they are not suitable for participating in the trial; 5. Those with known or suspected history of immunodeficiency disease (such as a history of frequent recurrent infections), hereditary or acquired complement deficiency; 6. Those who had a clear history of capsule microbial infection within the previous 6 months; including but not limited to: Streptococcus pneumoniae, Bacillus anthracis, Salmonella, Salmonella typhi, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, Neisseria meningitidis, Haemophilus influenzae, Legionella pneumophila infection history, etc.; 7. Those who have a history of tuberculosis infection or are currently suffering from tuberculosis; 8. Those who had active systemic bacterial, viral or fungal infections within 14 days before the first administration; 9). Those who had active pathological bleeding in the past or before the administration, such as digestive ulcers or intracranial bleeding; 10. Those with liver dysfunction, kidney dysfunction, or biliary obstruction; 11. Those who have an allergy to the test drugs, any of their components, or related preparations, or have a history of drug, food, or other substance allergies; 12. Those who cannot tolerate venipuncture or have a history of fainting or needle shock; 13. Those who have undergone surgery judged by the investigator to affect drug absorption, distribution, metabolism, or excretion within the previous 6 months; or those who have undergone surgery within the previous 30 days; or those who plan to undergo surgery during the trial; 14. Those who have used any drugs within the previous 14 days (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, Chinese patent medicines, and dietary supplements, etc.); or those whose drugs have been within 5 half-lives of screening (with the longer time being the standard); 15.Those who have received vaccines or attenuated live vaccines (meningococcal vaccine and pneumococcal vaccine) before the screening, or plan to receive vaccines during the trial; 16. Those whose QTc is >= 450 msec (for males) or >= 460 msec (for females) at the time of screening; 17. Those who have donated blood or suffered massive blood loss (> 400 mL), received blood transfusion or used blood products within the previous 3 months, or plan to donate blood or blood components within 3 months after the trial; 18. Those who are drug abusers or have used soft drugs (such as marijuana) or hard drugs (such as cocaine, phencyclidine, etc.) within the previous 1 year; or those with positive results in the urine test; 19. Those who smoke heavily or have smoked more than 5 cigarettes per day within the previous 3 months, or who cannot stop using any tobacco products during the trial; 20. Those who are heavy drinkers or have frequently drunk within the previous 6 months, that is, more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol liquor or 150 mL of wine); or those who are unwilling to stop drinking alcohol or any alcoholic products during the trial or have a positive alcohol breath test; 21. Those who consume more than 8 cups of tea, coffee, and/or caffeinated beverages per day (1 cup = 250 mL), or who do not agree to stop consuming tea, coffee, and/or caffeinated beverages during the trial. 22. Those who have consumed food within 7 days prior to admission that may affect the metabolism of the drug (including grapefruit or grapefruit products, etc.), or those whose diet is considered by the researchers to have an impact on the absorption, distribution, metabolism, or excretion of the drug, or those who do not agree to stop consuming such diet during the trial; 23. Those with special dietary requirements who cannot follow the unified diet; 24. Female trial participants who are pregnant or breastfeeding; or those who have had unprotected sexual intercourse within 14 days prior to admission; or those who used oral contraceptives within 30 days prior to admission or used long-acting estrogen or progesterone injections or implants within 6 months prior to admission; 25. Trial participants (or their partners) who have a pregnancy plan, sperm donation or egg donation plan, or who are unwilling to adopt one or more non-drug contraceptive measures (such as complete abstinence, contraceptive ring, partner's sterilization, etc.) from the time they signed the informed consent form until 3 months after the last administration; 26.Those with abnormal physical examinations, electrocardiograms, abdominal B-ultrasound, chest anteroposterior radiographs, laboratory tests (complete blood count, urine routine, blood biochemistry, procalcitonin, coagulation function, thyroid function three items, blood transfusion four items, female blood pregnancy), vital signs, and abnormal results of various examinations (judged by the research doctor); 27. Those with positive alcohol breath test or drug abuse screening results; 28.Trial participants may not be able to complete this study for other reasons or those judged by the researchers to have other reasons that are not suitable for participating in the trial.

研究实施时间：

Study execute time：

从 From 2026-04-28 00:00:00至 To 2026-06-10 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-04-28 00:00:00 至 To 2026-05-31 00:00:00

干预措施：

Interventions：

组别：	利福平组	样本量：	18
Group：	Rifampicin group	Sample size：	18
干预措施：	第 1 天和第 20 天早晨空腹状态下（给药前至少禁食 10 小时）单次服用 NTQ5082 胶囊 200 毫克（2 粒×100 毫克），第 7 天~第 24 天每天早晨单次空腹状态下服用利福平胶囊 600 毫克（4 粒×150 毫克）。	干预措施代码：
Intervention：	On the 1st and 20th day, take a single dose of NTQ5082 capsules at an empty stomach state (fasting for at least 10 hours before administration), 200 milligrams (2 capsules × 100 milligrams). From the 7th day to the 24th day, take rifampicin capsules at an empty stomach state every morning, 600 milligrams (4 capsules × 150 milligrams).	Intervention code：

组别：	氯吡格雷组	样本量：	18
Group：	Clopidogrel group	Sample size：	18
干预措施：	第 1 天和第 9 天早晨空腹状态下（给药前至少禁食 10 小时）单次服用 NTQ5082 胶囊 200 毫克（2 粒×100 毫克），第 8 天早晨空腹状态下服用硫酸氢氯吡格雷片 300 毫克（4 片×75 毫克），第 9 天~第 14 天每天早晨单次空腹状态下服用硫酸氢氯吡格雷片 75 毫克（1 片×75 毫克）。	干预措施代码：
Intervention：	On the 1st and 9th days, on an empty stomach (fasting for at least 10 hours before administration), take a single dose of NTQ5082 capsules 200 mg (2 capsules × 100 mg) in the morning. On the 8th day, take a 300 mg tablet of acetylsalicylic acid clopidogrel (4 tablets × 75 mg) on an empty stomach in the morning. From the 9th day to the 14th day, take a single dose of 75 mg of acetylsalicylic acid clopidogrel (1 tablet × 75 mg) on an empty stomach in the morning each day.	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临床试验研究中心	单位级别：	三级甲等
Institution hospital：	Clinical Trial Research Center of Xiangya Third Hospital of Central South University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	12-导联心电图指标	指标类型：	次要指标
Outcome：	12-lead electrocardiogram indicators	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	生命体征	指标类型：	次要指标
Outcome：	Vital signs	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	药代动力学暴露参数：Cmax、AUC0-t、AUC0-∞	指标类型：	主要指标
Outcome：	Pharmacokinetic exposure parameters: Cmax, AUC0-t, AUC0-∞	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	使用后保存	说明
Fate of sample：	Preservation 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	45	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）：

无

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

None

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：	无
Blinding：	None

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：	数据采集:由研究者或其授权的CRC通过独立的账号进入数据管理系统，进行数据采集.数据管理:数据管理员根据方案设计eCRF，eCRF中包含除外部数据外方案中规定的全部数据点。由EDC系统直接导出eCRF(PDF格式).
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Data collection: The researcher or their authorized CRC accesses the data management system through an independent account to conduct data collection. Data management: The data manager follows the protocol design to create the eCRF, which includes all the data points stipulated in the protocol in addition to external data. The eCRF is directly exported from the EDC system (in PDF format).
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2026-04-27 15:09:15