ChiCTR2600123317 版本V1.0 版本创建时间2026/04/23 18:07:49 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：

ChiCTR2600123317 

最近更新日期：

Date of Last Refreshed on：

2026-04-23 18:07:44 

注册时间：

Date of Registration：

2026-04-23 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

玛巴洛沙韦片人体生物等效性研究

Public title：

Bioequivalence Study of Baloxavir Marboxil Tablets in Humans

注册题目简写：

English Acronym：

研究课题的正式科学名称：

玛巴洛沙韦片人体生物等效性研究

Scientific title：

Bioequivalence Study of Baloxavir Marboxil 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：

谭亲友 

研究负责人：

谭亲友 

Applicant：

Tan Qinyou 

Study leader：

Tan Qinyou 

申请注册联系人电话：

Applicant telephone：

+86 773 288 2506

研究负责人电话：

Study leader's telephone：

+86 773 288 2506

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：

tqy1013@126.com

研究负责人电子邮件：

Study leader's E-mail：

tqy1013@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：

广西壮族自治区桂林市秀峰区乐群路15号

研究负责人通讯地址：

广西壮族自治区桂林市秀峰区乐群路15号

Applicant address：

No. 15, Lequn Road, Xiufeng District, Guilin City, Guangxi Zhuang Autonomous Region

Study leader's address：

No. 15, Lequn Road, Xiufeng District, Guilin City, Guangxi Zhuang Autonomous Region

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：

桂林医科大学第一附属医院

Applicant's institution：

The First Affiliated Hospital of Guilin Medical University

研究负责人所在单位：

桂林医科大学第一附属医院

Affiliation of the Leader：

The First Affiliated Hospital of Guilin Medical University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

BE2025002

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：

桂林医学院附属医院药物临床试验伦理委员会

Name of the ethic committee：

Ethics Committee for Drug Clinical Trials of the Affiliated Hospital of Guilin Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-01-20 00:00:00

伦理委员会联系人：

陈刚

Contact Name of the ethic committee：

Chen Gang

伦理委员会联系地址：

广西壮族自治区桂林市秀峰区翊武路 38 号

Contact Address of the ethic committee：

No. 38, Yizhuo Road, Xiufeng District, Guilin City, Guangxi Zhuang Autonomous Region

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 773 280 3369

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：

桂林医科大学第一附属医院

Primary sponsor：

The First Affiliated Hospital of Guilin Medical University

研究实施负责（组长）单位地址：

广西壮族自治区桂林市秀峰区乐群路15号

Primary sponsor's address：

No. 15, Lequn Road, Xiufeng District, Guilin City, Guangxi Zhuang Autonomous Region

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广西壮族自治区

市(区县)：

桂林

Country：

China

Province：

Guangxi Zhuang Autonomous Region

City：

Guilin

单位(医院)：

桂林医科大学第一附属医院

具体地址：

广西壮族自治区桂林市秀峰区乐群路15号

Institution
hospital：

The First Affiliated Hospital of Guilin Medical University

Address：

No. 15, Lequn Road, Xiufeng District, Guilin City, Guangxi Zhuang Autonomous Region

经费或物资来源：

研究经费由远大医药（中国）有限公司提供

Source(s) of funding：

The research funding is provided by Grand Pharma (China) Co., Ltd.

Target disease：

Influenza

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： 比较空腹和餐后给药条件下，远大医药（中国）有限公司提供的玛巴洛沙韦片（规格：20 mg）与RochePharma（Schweiz）AG持证的玛巴洛沙韦片（商品名：Xofluza?/速福达?；规格：20 mg）在中国健康人群吸收程度和吸收速度的差异。 次要目的： 评价空腹及餐后条件下，远大医药（中国）有限公司提供的玛巴洛沙韦片（规格：20 mg）与RochePharma（Schweiz）AG持证的玛巴洛沙韦片（商品名：Xofluza?/速福达?；规格：20 mg）在健康研究参与者体内的安全性。  

Objectives of Study：

Primary Objective: To compare the differences in the extent and rate of absorption of baloxavir marboxil tablets (specification: 20 mg) supplied by Grand Pharmaceutical (China) Co., Ltd. versus those marketed as Xofluza? (Chinese trade name: Sufuda?; specification: 20 mg) and held by Roche Pharma (Schweiz) AG, in healthy Chinese subjects under fasting and fed conditions. Secondary Objective: To evaluate the safety of baloxavir marboxil tablets (specification: 20 mg) supplied by Grand Pharmaceutical (China) Co., Ltd. in comparison with Xofluza? (Chinese trade name: Sufuda?; specification: 20 mg) held by Roche Pharma (Schweiz) AG, in healthy study participants under fasting and fed conditions.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

必须符合下列所有标准才能入选为研究参与者： 1.年龄在18周岁~60周岁（包含边界值）的中国健康研究参与者，男女兼可； 2.男性体重>=50 kg，女性体重>=45 kg，体重指数（BMI）在19.0-26.0 kg/m^2之间（BMI=体重（kg）/身高^2（m）），包括边界值； 3.试验前签署知情同意书、并对试验内容、过程及可能出现的不良反应充分了解； 4.研究参与者能够和研究者进行良好的沟通，并且理解和遵守本项研究的各项要求。 不符合上述条件之一者，不得作为研究参与者入选。

Inclusion criteria

To be eligible as a research participant, the following criteria must be met: 1. Chinese healthy research participants aged between 18 and 60 years old (inclusive of the boundaries), both male and female are acceptable; 2. Male weight >= 50 kg, female weight >= 45 kg, with a body mass index (BMI) within the range of 19.0 - 26.0 kg/m^2 (BMI = weight (kg) / height^2 (m)), including the boundaries; 3. Signed the informed consent form before the trial and fully understood the trial content, process and possible adverse reactions; 4. The research participants can communicate well with the researchers and understand and comply with all the requirements of this study. Those who do not meet any of the above conditions shall not be selected as research participants.

排除标准：

符合一条或多条下列标准的研究参与者将被排除： 1.试验前90天内参加了任何药物临床试验且使用研究药物者或参加了药物实验，且时间未达到所服研究药物10个半衰期者；（问诊+联网筛查） 2.对本药物任何一种成分过敏，或有药物、食物或其他物质过敏史者；（问诊） 3.吞咽困难，或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、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；（问诊） 4.有呼吸系统、心血管系统、内分泌系统、泌尿系统、神经系统、血液学、免疫学（包括个人或家族史遗传性免疫缺陷）、代谢异常等病史且研究者认为目前仍有临床意义者；（问诊） 5.有体位性低血压，或不能耐受静脉穿剌或有晕血、晕针史者，或静脉采血困难者；（问诊） 6.使用研究药物前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；或试验前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；（问诊） 7.使用研究药物前2周内因各种原因使用过任何药物（包括中草药、保健品等）者；（问诊） 8.使用研究药物前30天内使用过或计划在研究期间使用任何影响研究药物吸收代谢（包括肝酶抑制剂、诱导剂或改变胃肠道环境），或与研究药物有相互作用的药物（如丙磺舒、P-糖蛋白阻断剂（伊曲康唑）或含高价阳离子的泻药、抗酸药或口服补充剂（如，钙、铁、镁、硒或锌）），经研究者判断不宜参加试验者；（问诊） 9.使用研究药物前14天内接种疫苗或减毒活疫苗，或计划会在试验期间接种疫苗者；（问诊） 10.使用研究药物前3个月内献血或大量失血（＞400 mL，女性生理期除外）者，或计划在试验期间或试验结束后3个月内献血或血液成份者；（问诊+联网筛查） 11.药物滥用者或使用研究药物前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；（问诊） 12.嗜烟者或使用研究药物前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；（问诊） 13.酗酒者或使用研究药物前6个月内经常饮酒者，即每周饮酒超过14单位酒精（1单位=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的制品；（问诊） 14.使用研究药物前3个月每天饮用过量茶、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；（问诊） 15.对饮食有特殊要求，不能遵守统一饮食者，或对乳糖不耐受者，或有遗传性半乳糖不耐受、乳糖酶缺乏或葡萄糖-半乳糖吸收不良病史者；（问诊） 16.使用研究药物前72 h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，或不同意试验期间停止进食上述饮食者；（问诊）； 17.研究参与者（或其伴侣）试验期间至试验结束后3个月内有妊娠计划、捐精捐卵计划，或试验期间不愿采取一种或一种以上的非药物避孕措施（如完全禁欲、避孕套、避孕环、伴侣结扎等）者；女性研究参与者为妊娠或哺乳期女性，或在使用研究药物前2周内发生非保护性性行为者；（问诊） 18.试验前心电图、实验室检查、生命体征、体格检查各项检查异常且有临床意义者（以临床研究医生判断为准）； 19.尿药筛查试验阳性者； 20.酒精呼气测试结果＞0.0 mg/100 mL者； 21.女性血妊娠试验异常有临床意义者； 22.研究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原因不宜参加试验者。

Exclusion criteria：

Study participants meeting one or more of the following criteria will be excluded from the trial: 1. Having participated in any clinical drug trial and received investigational drugs within 90 days prior to the current trial; or having participated in a drug trial with an interval shorter than 10 half-lives of the previously administered investigational drug. (Medical interview + network-based screening) 2. Having a history of hypersensitivity to any component of the study drug, or a documented history of allergies to drugs, foods, or other substances. (Medical interview) 3. Having dysphagia; or a history of chronic or active gastrointestinal diseases (e.g., esophageal disorders, gastritis, gastric ulcer, enteritis), active gastrointestinal bleeding, or gastrointestinal surgery within the past 3 years, which is deemed clinically significant by the investigator at the time of screening. (Medical interview) 4. Having a history of diseases involving the respiratory, cardiovascular, endocrine, urinary, nervous, hematological, or immune systems (including personal or familial history of hereditary immunodeficiency), or metabolic disorders, which is deemed clinically significant by the investigator at the time of screening. (Medical interview) 5. Having orthostatic hypotension; or a history of intolerance to venipuncture, hematophobia, or trypanophobia; or experiencing recurrent difficulties with venous blood collection. (Medical interview) 6. Having undergone any surgery within 6 months prior to study drug administration that, in the investigator’s judgment, may affect drug absorption, distribution, metabolism, or excretion; or having undergone any surgical procedure within 4 weeks prior to the trial; or having a planned surgical intervention during the study period. (Medical interview) 7. Having taken any medications (including traditional Chinese herbal medicines and dietary supplements) for any reason within 2 weeks prior to study drug administration. (Medical interview) 8. Having used any drugs that may interfere with the absorption or metabolism of the study drug (including hepatic enzyme inhibitors, inducers, or agents altering gastrointestinal environment) or have potential drug-drug interactions with the study drug (e.g., probenecid, P-glycoprotein inhibitors [e.g., itraconazole], or laxatives, antacids, or oral supplements containing high-valence cations [e.g., calcium, iron, magnesium, selenium, or zinc]) within 30 days prior to study drug administration; or planning to use such drugs during the study period, and being deemed unsuitable for trial participation by the investigator. (Medical interview) 9. Having received any vaccine or live-attenuated vaccine within 14 days prior to study drug administration; or planning to receive any vaccine during the trial period. (Medical interview) 10. Having donated blood or experienced massive blood loss (> 400 mL, excluding menstrual bleeding in females) within 3 months prior to study drug administration; or planning to donate blood or blood components during the trial period or within 3 months after trial completion. (Medical interview + network-based screening) 11. Being a substance abuser; or having a history of using soft drugs (e.g., cannabis) or hard drugs (e.g., cocaine, phencyclidine) within 1 year prior to study drug administration. (Medical interview) 12. Being a regular smoker; or having smoked more than 5 cigarettes per day within 3 months prior to study drug administration; or being unable to abstain from all tobacco products during the trial period. (Medical interview) 13. Being an alcohol abuser; or having a history of regular alcohol consumption within 6 months prior to study drug administration, defined as consuming more than 14 units of alcohol per week (1 unit = 360 mL of beer, or 45 mL of spirits containing 40% alcohol by volume, or 150 mL of wine); or being unwilling to abstain from alcohol or any alcohol-containing products during the trial period. (Medical interview) 14. Having consumed excessive amounts of tea, coffee, and/or caffeinated beverages (more than 8 cups per day, 1 cup = 250 mL) within 3 months prior to study drug administration; or refusing to abstain from such beverages during the trial period. (Medical interview) 15. Having special dietary requirements that prevent compliance with the standardized study diet; or having lactose intolerance; or having a history of hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. (Medical interview) 16. Having consumed any foods that may interfere with the in vivo metabolism of the study drug (including grapefruit or grapefruit products) within 72 hours prior to study drug administration; or having consumed other diets deemed by the investigator to affect drug absorption, distribution, metabolism, or excretion; or refusing to abstain from such foods during the trial period. (Medical interview) 17. For male or female participants (or their partners): having plans for pregnancy, sperm donation, or oocyte donation during the trial period or within 3 months after trial completion; or refusing to adopt one or more non-pharmacological contraceptive methods (e.g., complete abstinence, condoms, intrauterine devices, partner sterilization) during the trial period. For female participants: being pregnant or lactating; or having engaged in unprotected sexual intercourse within 2 weeks prior to study drug administration. (Medical interview) 18. Having clinically significant abnormalities in pre-trial electrocardiogram (ECG), laboratory tests, vital signs, or physical examination findings, as determined by the investigator. 19. Testing positive for urine drug screening. 20. Having an alcohol breath test result > 0.0 mg/100 mL. 21. For female participants: having clinically significant abnormalities in serum pregnancy test results. 22. Being considered by the investigator to be unable to complete the study for other reasons, or being deemed otherwise unsuitable for trial participation.

研究实施时间：

Study execute time：

从 From 2025-02-22 00:00:00至 To 2025-05-16 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-03-03 00:00:00 至 To 2025-03-12 00:00:00  

干预措施：

Interventions：

组别：

空腹组

样本量：

42

Group：

The fasting group

Sample size：

干预措施：

第一周期：研究参与者于给药前2天入住病房，给药前禁食8 h以上，试验当天早上空腹单次口服受试制剂或参比制剂1片（20 mg），240 mL水送服，服药前后1 h内禁止饮水（服药时的240 mL水除外），服药后4 h内禁食。 第二周期：经过不少于35天的清洗期后，按研究参与者随机表口服参比制剂或受试制剂1片，服药要求与第一周期相同。

干预措施代码：

Intervention：

Period 1: Study participants were admitted to the clinical research ward 2 days prior to drug administration. They were required to fast for at least 8 hours before dosing. On the trial day, each participant received a single oral dose of either the test formulation or the reference formulation (1 tablet, 20 mg) after an overnight fast, with 240 mL of water. Water intake was prohibited within 1 hour before and after dosing (excluding the 240 mL of water used for drug administration). Fasting was maintained for 4 hours after drug administration. Period 2: Following a washout period of no less than 35 days, participants received the alternate formulation (reference or test formulation, 1 tablet) according to the randomization schedule, with the same dosing requirements as those applied in Period 1.

Intervention code：

组别：

餐后组

样本量：

34

Group：

Postprandial group

Sample size：

干预措施：

第一周期：研究参与者于试验前2天入住病房，食用高脂餐前禁食8 h以上。在服药前30 min时开始进食高脂高热量餐，并在30 min内用餐完毕，开始进餐后30 min时（+/-1 min）用240 mL水单次送服受试制剂或参比制剂1片（20 mg），服药前后1 h内禁止饮水（服药时的240 mL水和高脂餐所含液体除外），服药后4 h内禁食。 第二周期：经过不少于35天的清洗期后，按研究参与者随机表口服参比制剂或受试制剂1片，服药要求与第一周期相同。

干预措施代码：

Intervention：

Period 1:Study participants were admitted to the clinical research ward 2 days prior to the trial. They were required to fast for at least 8 hours before consuming the high-fat meal.Thirty minutes prior to drug administration, participants started a high-fat and high-calorie meal, which was completed within 30 minutes. At 30 minutes (+/-1 min) after the start of the meal, each participant received a single oral dose of either the test formulation or the reference formulation (1 tablet, 20 mg), with 240 mL of water.Water intake was prohibited within 1 hour before and after dosing, excluding the 240 mL of water used for drug administration and the liquids contained in the high-fat meal. Fasting was maintained for 4 hours after drug administration. Period 2: Following a washout period of no less than 35 days, participants received the alternate formulation (reference or test formulation, 1 tablet) according to the randomization schedule, with the same dosing requirements as those applied in Period 1.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广西壮族自治区 

市(区县)：

 桂林 

Country：

China 

Province：

Guangxi Zhuang Autonomous Region 

City：

Guilin 

单位(医院)：

桂林医科大学第一附属医院 

单位级别：

三甲 

Institution
hospital：

The First Affiliated Hospital of Guilin Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

血药浓度 - 时间曲线下面积

指标类型：

主要指标

Outcome：

Blood drug concentration - Area under the time curve

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

最大血药浓度

指标类型：

主要指标

Outcome：

Maximum blood drug concentration

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：

次要指标

Outcome：

Peak time

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

终末消除速率常数

指标类型：

次要指标

Outcome：

Terminal elimination rate constant

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

药物半衰期

指标类型：

次要指标

Outcome：

Drug half-life

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：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 60 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）：

随机化由随机化单位长沙科乐维科技有限公司的随机人员使用SAS统计软件(版本号9.4)产生研究参与者随机分组表和药品随机抽样表，以密封信封的形式交由负责本试验的研究机构，负责拆阅随机信封者必须签字予以确认。如需添加额外的研究参与者区组或因增加研究参与者导致需再抽取试验药物时，如无需修改随机方法则均不升级本随机化方案，将按照本随机化方案规定的随机方法出具新增的随机分组/抽样表，以密封信封的形式交由负责本试验的研究机构，负责拆阅随机信封者必须签字予以确认。

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

Randomization will be performed by personnel from Changsha Kelewei Technology Co., Ltd. (the randomization unit) using SAS statistical software (version 9.4) to generate the randomization schedule for study participants and the random sampling schedule for study drugs. These schedules will be provided to the research institution responsible for the trial in the form of sealed envelopes, and the personnel responsible for opening the randomization envelopes must sign to confirm. If additional participant blocks need to be added or additional study drugs need to be sampled due to an increase in participants, and there is no need to modify the randomization method, the randomization scheme will not be upgraded. New randomization/sampling schedules will be generated in accordance with the randomization method specified in this scheme, provided to the responsible research institution in sealed envelopes, and the personnel responsible for opening the randomization envelopes must sign to confirm.

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：

无

Blinding：

None

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

Yes

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）：

研究结束后半年内，通过ResMan(www.medresman.org.cn)方式共享

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

Within six months after the completion of the research, the results will be shared via the ResMan platform (www.medresman.org.cn)

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：

  2026-04-23 18:07:44