ChiCTR2400093679 版本V1.0 版本创建时间2024/12/10 14:15:19 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：

 ChiCTR2400093679 

最近更新日期：

Date of Last Refreshed on：

 2024-12-10 14:15:05 

注册时间：

Date of Registration：

 2024-12-10 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

中国健康受试者空腹和餐后状态下口服阿昔洛韦片的生物等效性试验

Public title：

Bioequivalence trial of oral acyclovir tablets in fasting and postprandial state in healthy Chinese subjects

注册题目简写：

English Acronym：

研究课题的正式科学名称：

中国健康受试者空腹和餐后状态下口服阿昔洛韦片单中心、随机、开放、单剂量、两周期、两序列、交叉设计的生物等效性试验

Scientific title：

A single-center, randomized, open, single-dose, two-cycle, two-sequence, cross-over bioequivalence trial of oral acyclovir tablets during fasting and postprandial 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：

徐璐薇 

研究负责人：

徐璐薇 

Applicant：

Xu Luwei 

Study leader：

Xu Luwei 

申请注册联系人电话：

Applicant telephone：

 +86 15061003175

研究负责人电话：

Study leader's
telephone：

+86 15061003175

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：

 1511048942@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 283452112@qq.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：

江苏省泰州市海陵区济川东路86号

研究负责人通讯地址：

江苏省泰州市海陵区济川东路86号（东院）

Applicant address：

No.86, East Jichuan Road, Hailing District, Taizhou City, Jiangsu Province

Study leader's address：

No. 86, Jichuan East Road, Hailing District, Taizhou City, Jiangsu Province

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：

泰州市中医院

Applicant's institution：

Taizhou Hospital of Traditional Chinese Medicine

研究负责人所在单位：

泰州市中医院

Affiliation of the Leader：

Taizhou Hospital of Traditional Chinese Medicine

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：

 2024-049-01

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：

泰州市中医院伦理审查委员会

Name of the ethic committee：

Taizhou Hospital of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-11-11 00:00:00

伦理委员会联系人：

刘影

Contact Name of the ethic committee：

Liu Ying

伦理委员会联系地址：

江苏省泰州市海陵区济川东路86号（东院）

Contact Address of the ethic committee：

No. 86, Jichuan East Road, Hailing District, Taizhou City, Jiangsu Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 523 86611963

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 1511048942@qq.com

研究实施负责（组长）单位：

泰州市中医院

Primary sponsor：

Taizhou Hospital of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

江苏省泰州市海陵区济川东路86号（东院）

Primary sponsor's address：

No. 86, Jichuan East Road, Hailing District, Taizhou City, Jiangsu Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江苏

市(区县)：

Country：

China

Province：

Jiangsu

City：

单位(医院)：

泰州市中医院

具体地址：

江苏省泰州市海陵区济川东路86号（东院）

Institution
hospital：

Taizhou Hospital of Traditional Chinese Medicine

Address：

No. 86, Jichuan East Road, Hailing District, Taizhou City, Jiangsu Province

经费或物资来源：

浙江车头制药股份有限公司

Source(s) of funding：

Zhejiang Locomotive Pharmaceutical Co., LTD

研究疾病：

单纯疱疹病毒  

Target disease：

Herpes simplex virus

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：

主要研究目的 研究空腹和餐后状态下单次口服受试制剂阿昔洛韦片（规格：0.4g，浙江京新药业股份有限公司生产，浙江车头制药股份有限公司持证）与参比制剂阿昔洛韦片（规格：400mg，商品名：Zovirax，グラクソ?スミスクライン株式会社生产，Glaxo Smithkline K.K.持证），在健康成年受试者体内的药代动力学，评价空腹和餐后口服两种制剂的生物等效性。 次要研究目的 评价中国健康受试者空腹和餐后状态下，单次口服受试制剂阿昔洛韦片和参比制剂阿昔洛韦片（Zovirax）后的安全性。  

Objectives of Study：

Main research purpose Study fasting and postmeal status of single oral test preparation acyclovir tablets (specification: 0.4g, Zhejiang Jingxin Pharmaceutical Co., LTD., Zhejiang Locomotive Pharmaceutical Co., LTD.) and reference preparation acyclovir tablets (specification: 400mg, product name: Glaxo Smithkline K.K. Zovirax, グラクソ · スミスクライン Co., LTD. Licensed), pharmacokinetics in healthy adult subjects to evaluate the bioequivalence of both formulations by fasting and oral postprandial administration. Secondary research purpose To evaluate the safety of single oral administration of acyclovir tablet and reference acyclovir tablet (Zovirax) during fasting and postprandialconditions in healthy Chinese 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：

1.年龄：18-65周岁的健康男性和未怀孕非哺乳期的女性受试者（含临界值）； 2.体重：男性需≥50.0 kg，女性需≥45.0 kg，【BMI=体重（kg）/身高2（m^2 ）】在19.0~26.0 kg/m^2 （含临界值）； 3.体格检查、生命体征检查、心电图检查、筛选期临床实验室检查及其他辅助检查结果显示正常或经研究者判断异常无临床意义者； 4.筛选（女性自筛选日前2周）至研究结束后3个月内自愿采取有效避孕措施进行避孕，且未来3个月内无生育计划或捐精、捐卵计划者； 5.对知情同意书的内容充分理解并自愿签署，自愿参加该研究； 6.能够与研究者良好沟通并能够按照研究方案要求完成研究。

Inclusion criteria

1.Age: healthy males aged 18-65 years and non-pregnant non-lactating females (including cut-off); 2.Weight: male need >=50.0 kg, female need >=45.0 kg, [BMI= weight (kg)/height 2 (m^2)] in 19.0~26.0 kg/m^2 (including the critical value); 3.Physical examination, vital signs examination, electrocardiogram examination, clinical laboratory examination during screening period and other auxiliary examination results showed normal or abnormal clinical significance judged by the investigator; 4.Screening (women from 2 weeks before the screening day) to 3 months after the end of the study to take effective contraception, and in the next 3 months no fertility plans or sperm donation, egg donation plan; 5.Fully understand the content of the informed consent and sign it voluntarily to participate in the study; 6.Able to communicate well with researchers and complete research according to research protocol requirements.

排除标准：

1.对阿昔洛韦或伐昔洛韦类药物或其中某种活性成分或辅料有过敏史者；曾出现对两种或两种以上药物、食物等过敏史者；属于过敏体质者；
2.有吞咽困难，或乳糖不耐受（曾发生过喝牛奶腹泻）者，或对饮食有特殊要求，不能接受统一饮食者；
3.有任何内分泌系统、泌尿系统、消化系统、血液和淋巴系统、呼吸系统、心血管系统、神经系统、精神疾病、肌肉骨骼系统、皮肤系统等上述系统的慢性或严重疾病者且研究医生判断异常有临床意义者；
4.筛选前3个月内饮用过量（一天8杯以上，1杯=250mL）浓茶、浓咖啡和/或含咖啡因的饮料者，或试验开始给药前48h内摄取了任何含有或代谢后产生咖啡因或富含黄嘌呤食物或饮料（如咖啡、茶、巧克力等），或不同意在整个试验期间停止服用这些食物或饮料者；
5.筛选前6个月内每周饮酒量大于14单位酒精（1单位酒精=360 mL啤酒或45 mL酒精含量为40%的烈酒或150 mL葡萄酒）或筛选日至研究结束不能禁酒者；
6.筛选前3个月内每日吸烟量大于5支，或不同意在筛选日至研究结束期间停止使用任何烟草类产品者；
7.筛选前14天内使用过任何药物（包括处方药、非处方药、维生素补充剂或中草药）、保健品者；
8.筛选前30天内使用过任何与抑制或诱导肝脏对药物代谢的药物或与阿昔洛韦存在相互作用的药物（如：诱导剂-巴比妥类、卡马西平、苯妥英钠、利福平等；抑制剂-SSRI类抗抑郁药、西咪替丁、环孢素、大环内酯类、维拉帕米、喹诺酮类、吡咯类抗真菌药、HIV蛋白酶抑制剂等；丙磺舒、茶碱、霉酚酸酯代谢物、齐多夫定、干扰素或甲氨蝶呤（鞘内）等）者；
9.筛选前6个月内有药物滥用史者，筛选前3个月内使用过毒品者；
10.筛选前3个月内入组过其他的药物或器械临床研究者；
11.筛选前1个月内接种过疫苗者；
12.筛选前3个月内献血（包括成分血）或大量失血（≥400 mL），接受输血或使用血制品者，或计划在研究期间或研究结束后一个月内献血者；
13.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，及曾接受过会影响药物吸收、分布、代谢、排泄的手术者；
14.不能保证从给药前48小时到研究结束前禁食特殊饮食（包括葡萄柚、巧克力、茶、可乐，或者任何含咖啡因的食品或饮料、含酒精的饮料或其他影响药物吸收、分布、代谢、排泄的食品或饮料）者；
15.不能耐受静脉穿刺者，有晕针晕血史者，静脉评估不合格者；
16.女性受试者在筛查期妊娠检查结果呈阳性或经研究者判断异常有临床意义或处于哺乳期者；
17.筛选期间药物滥用筛查、酒精呼气检测结果呈现阳性或经研究者判断异常者；
18.研究者认为其他原因不适合入组的受试者；
19.因自身原因无法完成研究的受试者。

Exclusion criteria：

1.Have a history of allergy to acyclovir or valaciclovir drugs or one of their active ingredients or excipients; Have a history of allergy to two or more drugs, foods, etc.; Those who are allergic;
2.People who have difficulty swallowing, or lactose intolerance (have had diarrhea from drinking milk), or have special dietary requirements and cannot accept a uniform diet;
3.Have any chronic or severe diseases of endocrine system, urinary system, digestive system, blood and lymphatic system, respiratory system, cardiovascular system, nervous system, mental disease, musculoskeletal system, skin system and other systems mentioned above, and the study doctor judges that the abnormalities are clinically significant;
4.Those who consumed excessive (more than 8 cups a day, 1 cup =250mL) strong tea, strong coffee and/or caffeinated beverages in the 3 months prior to screening, or consumed any food or beverage containing or metabolically producing caffeine or rich in xanthines (such as coffee, tea, chocolate, etc.) within 48 hours prior to the start of the trial, Or do not agree to stop taking these foods or drinks throughout the trial;
5.Those who consumed more than 14 units of alcohol per week in the 6 months prior to screening (1 unit of alcohol =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine) or could not abstaining from alcohol from the screening date to the end of the study;
6.Smoking more than 5 cigarettes per day in the 3 months prior to screening, or not agreeing to stop using any tobacco products between the screening date and the end of the study;
7.People who have used any drugs (including prescription drugs, over-the-counter drugs, vitamin supplements or Chinese herbs) or health products in the 14 days prior to screening;
8.Any drug that inhibits or induces liver metabolism of drugs or interacts with acyclovir (e.g., inducers - barbiturates, carbamazepine, phenytoin, rifampin) used within 30 days prior to screening; Inhibitors -SSRI antidepressants, cimetidine, cyclosporine, macrolides, verapamil, quinolones, pyrrole antifungal drugs, HIV protease inhibitors, etc.; Prosulfasol, theophylline, mycophenolate metabolites, zidovudine, interferon or methotrexate (intrathecal), etc.);
9.History of drug abuse in the 6 months prior to screening, use of drugs in the 3 months prior to screening;
10.Other drug or device clinical investigators enrolled within 3 months prior to screening;
11.Vaccinated within 1 month prior to screening;
12.Blood donation (including component blood) or significant blood loss (≥400 mL) within 3 months prior to screening, receiving transfusions or using blood products, or planning to donate blood during the study period or within one month after the study ends;
13.Patients who had surgery within 3 months prior to screening, or who planned to have surgery during the study period, or who had surgery that would affect drug absorption, distribution, metabolism, or excretion;
14.A special diet (including grapefruit, chocolate, tea, cola, or any food or beverage containing caffeine, alcoholic beverage, or other food or beverage that affects the absorption, distribution, metabolism, or excretion of the drug) cannot be guaranteed from 48 hours before dosing until the end of the study;
15.Patients who cannot tolerate venipunction, have a history of fainting needles and fainting blood, and fail to pass venous assessment;
16.Female subjects with positive pregnancy test results during the screening period or abnormalities judged by researchers to be clinically significant or breastfeeding;
17.During the screening period, drug abuse screening, alcohol breath test results were positive or abnormal as determined by the investigator;
18.Subjects deemed unsuitable for inclusion by the researcher for other reasons;
19.Subjects who are unable to complete the study due to their own reasons.

研究实施时间：

Study execute time：

从 From 2024-12-19 00:00:00至 To 2025-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-12-19 00:00:00 至 To 2025-06-01 00:00:00

干预措施：

Interventions：

组别：

空腹组

样本量：

 30

Group：

Fasting group

Sample size：

干预措施：

空腹服用阿昔洛韦片受试制剂或参比制剂

干预措施代码：

Intervention：

Take acyclovir tablet test preparation or reference preparation on an empty stomach

Intervention code：

组别：

餐后组

样本量：

 24

Group：

Postprandial group

Sample size：

干预措施：

餐后服用阿昔洛韦片受试制剂或参比制剂

干预措施代码：

Intervention：

Take acyclovir tablet test preparation or reference preparation after meal

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏 

市(区县)：

  

Country：

China

Province：

Jiangsu

City：

单位(医院)：

 泰州市中医院 

单位级别：

 三甲 

Institution
hospital：

Taizhou Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

峰浓度、达峰时间、AUC0-t、AUC0-∞、消除半衰期、消除速率常数、AUC0-∞外推百分比

指标类型：

主要指标

Outcome：

Peak concentration, peak time, AUC0-T, AUC0-∞, elimination half-life, elimination rate constant, and percentage of extrapolation from AUC0-∞

Type：

Primary indicator

测量时间点：

第一、二周期采血结束后

测量方法：

实验室检测及统计分析

Measure time point of outcome：

After the first and second cycles of blood collection

Measure method：

Laboratory testing and statistical analysis

指标中文名：

生命体征检查（给药后24h±30min，包括体温、脉搏及血压）

指标类型：

次要指标

Outcome：

Vital signs examination (24h±30min after administration, including body temperature, pulse and blood pressure)

Type：

Secondary indicator

测量时间点：

筛选期、入组第-1，1，2，6天

测量方法：

仪器测量

Measure time point of outcome：

Screening period, enrollment day -1, 1, 2, 6 days

Measure method：

Instrumental measurement

指标中文名：

体格检查（皮肤黏膜、表浅淋巴结、头部、颈部、胸部、腹部、脊柱/四肢等）

指标类型：

次要指标

Outcome：

Physical examination (skin mucosa, superficial lymph nodes, head, neck, chest, abdomen, spine/limbs, etc.)

Type：

Secondary indicator

测量时间点：

筛选期、入组第-1，6天

测量方法：

仪器测量

Measure time point of outcome：

Screening period, day -1, day 6

Measure method：

Instrumental measurement

指标中文名：

12导联心电图、实验室检查（血生化、血常规、尿常规、凝血功能、传染病筛查等）、妊娠检查（限女性）

指标类型：

次要指标

Outcome：

12-lead electrocardiogram, laboratory test (blood biochemistry, blood routine, urine routine, coagulation function, infectious disease screening, etc.), pregnancy test (female only)

Type：

Secondary indicator

测量时间点：

筛选期和第二周期出组前

测量方法：

Measure time point of outcome：

Screening period and before the second cycle out of the group

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

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：

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 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）：

随机表由统计分析单位应用SAS 9.4（或以上版本）软件随机产生，该随机数据具有重现性，随机种子数需要保存。在试验开始前，空腹试验受试者随机表、餐后试验受试者随机表以及药物随机表由统计分析单位提供给临床研究单位，不得向检测分析单位提供任何形式的随机表或受试者用药信息。 随机表将由临床单位研究者保管并负责保证依从随机表进行随机。

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

A random table is randomly generated by SAS 9.4 (or later). The random data is reproducible and the number of random seeds must be saved. Before the start of the trial, the fasting test subject randomization table, the postprandial test subject randomization table and the drug randomization table were provided by the statistical analysis unit to the clinical research unit, and any form of randomization table or drug use information of subjects was not allowed to be provided to the testing analysis unit. The randomization table will be kept by the clinical unit investigator and is responsible for ensuring compliance with the randomization table.

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：

使用电子化数据采集（EDC）系统进行数据采集，研究中心指定人员通过安全网络将原始数据录入eCRF中。

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

The electronic Data acquisition (EDC) system is used for data acquisition, and the designated personnel of the research center input the original data into the eCRF through a secure network.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2024-12-10 14:15:05