ChiCTR2100051152 版本V1.3 版本创建时间2022/04/10 17:59:09 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：

ChiCTR2100051152 

最近更新日期：

Date of Last Refreshed on：

2022-04-10 17:40:44 

注册时间：

Date of Registration：

2021-09-15 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

请与我们联系上传伦理审批文件。 伏立康唑干混悬剂在中国健康受试者中单剂量、空腹用药、两制剂、两周期、两序列、随机、开放、自身交叉的平均生物等效性研究

Public title：

A single-dose, fasting, two-dose, two-cycle, two-sequence, randomized, open-label, self-crossover mean bioequivalence study of voriconazole dry suspension in healthy Chinese subjects

注册题目简写：

English Acronym：

研究课题的正式科学名称：

伏立康唑干混悬剂在中国健康受试者中单剂量、空腹用药、两制剂、两周期、两序列、随机、开放、自身交叉的平均生物等效性研究

Scientific title：

A single-dose, fasting, two-dose, two-cycle, two-sequence, randomized, open-label, self-crossover mean bioequivalence study of voriconazole dry suspension 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：

刘献芳 

研究负责人：

郭风雪 

Applicant：

Liu Xianfang 

Study leader：

Guo Fengxue 

申请注册联系人电话：

Applicant telephone：

+86 18632096620

研究负责人电话：

Study leader's telephone：

+86 17731998618

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：

1511494359@qq.com

研究负责人电子邮件：

Study leader's E-mail：

gfx0266@163.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：

河北省邢台市桥西区钢铁北路618号

研究负责人通讯地址：

河北省邢台市桥西区钢铁北路618号

Applicant address：

618 Gangtie Road North, Qiaoxi District, Xingtai, Hebei

Study leader's address：

618 Gangtie Road North, Qiaoxi District, Xingtai, Hebei

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：

邢台医学高等专科学校第二附属医院

Applicant's institution：

The Second Affiliated Hospital of Xingtai Medical College

研究负责人所在单位：

Affiliation of the Leader：

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：

XYEYCTEC-HS-78

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

邢台医学高等专科学校第二附属医院临床试验伦理委员会

Name of the ethic committee：

Ethics Committee of the Second Affiliated Hospital of Xingtai Medical College

伦理委员会批准日期：

Date of approved by ethic committee：

2021-05-26 00:00:00

伦理委员会联系人：

柳振芳

Contact Name of the ethic committee：

Liu Zhenfang

伦理委员会联系地址：

河北省邢台市桥西区钢铁北路618号

Contact Address of the ethic committee：

618 Gangtie Road North, Qiaoxi District, Xingtai, Hebei

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

邢台医学高等专科学校第二附属医院

Primary sponsor：

The Second Affiliated Hospital of Xingtai Medical College

研究实施负责（组长）单位地址：

河北省邢台市桥西区钢铁北路618号

Primary sponsor's address：

618 Gangtie Road North, Qiaoxi District, Xingtai, Hebei

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东

市(区县)：

珠海

Country：

China

Province：

Guangdong

City：

Zhuhai

单位(医院)：

珠海润都制药股份有限公司

具体地址：

金湾区三灶镇机场北路6号

Institution
hospital：

Zhuhai Rundu Pharmaceutical Co., Ltd.

Address：

6 Jichang Road North, Sanzao Town, Jinwan District

经费或物资来源：

珠海润都制药股份有限公司

Source(s) of funding：

Zhuhai Rundu Pharmaceutical Co., Ltd.

Target disease：

Invasive Aspergillus; candidemia in patients with non-neutropenic and other deep-tissue Candida infections; esophageal candidiasis; sporidiosis and fusarium

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：

1.主要研究目的：本研究以珠海润都制药股份有限公司生产的伏立康唑干混悬剂（规格：45g:3g）为受试制剂，原研持证商Pfizer Ltd的伏立康唑干混悬剂（商品名：Vfend?；规格：40mg/ml）为参比制剂，评估受试制剂和参比制剂在空腹条件下给药时的生物等效性。 2.次要研究目的：观察受试制剂和参比制剂在健康受试者中的安全性。  

Objectives of Study：

Main research purpose: In this study, voriconazole dry suspension (specification: 45g: 3g) produced by Zhuhai Rundu Pharmaceutical Co., Ltd. was used as the test preparation. The original research license holder Pfizer Ltd's voriconazole dry suspension (trade name: Vfend ?; Specification: 40mg/ml) is the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation when administered under fasting conditions. Secondary research purpose: to observe the safety of test preparations and reference preparations in healthy 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.性别：中国健康男性或女性受试者，性别比例适当；
2.年龄：18周岁以上（含18周岁）；
3.男性受试者不应低于50.0kg，女性受试者不应低于45.0kg，且体重指数（BMI）：19.0-26.0kg/m^2（包含边界值，体重指数（BMI）=体重（kg）/身高2（m^2））；
4.受试者必须在试验前对本研究知情同意，并自愿签署书面的知情同意书；
5.受试者能够与研究者作良好的沟通并能够依照方案规定完成研究。

Inclusion criteria

1. Gender: Chinese healthy subjects, no gender limit, with appropriate gender ratio;
2. Age: over 18 years old (including 18 years old);
3. Male subjects should not be less than 50.0kg, female subjects should not be less than 45.0kg, and body mass index (BMI): 19.0-26.0kg/m^2 (Boundary values are included, body mass index (BMI) = weight (kg) / height 2 (m^2));
4. Subjects must give informed consent to this study before the trial, and voluntarily sign a written informed consent;
5. The subject can communicate well with the investigator and complete the study in accordance with the protocol.

排除标准：

1)过敏体质或有药物、食物过敏史，或已知对伏立康唑过敏；
2)研究者认为具有临床上有意义的肝、肾、内分泌、心血管、神经、精神、胃肠道（如消化性溃疡病）、肺、肿瘤、免疫、五官、皮肤、生殖、血液或代谢紊乱等疾病或任何其他疾病，或具有这些疾病的病史，或曾有过重大手术史，或将危害受试者的安全或影响研究结果的因素；
3)体格检查、生命体征测量、实验室检查（血常规、尿常规、血生化、凝血功能、血妊娠（仅限女性受试者）、血清病毒学）、12导联心电图检查结果研究者判断异常有临床意义；
4)试验期间及研究结束后3个月内，受试者或其伴侣有妊娠计划或不愿意使用医学上可接受的避孕方法，或受试者有捐精/捐卵计划；
5)妊娠期、哺乳期妇女，或育龄女性入组前14天内未采取适当避孕措施，或研究首次服药前30天内口服避孕药者，或试验前3个月内使用长效雌激素或孕激素注射剂或埋置片者；
6)具有药物滥用史，或药物滥用及毒品检测阳性，或习惯性服用任何药物（包括中草药）或功能性维生素；
7)筛选前14天内使用了任何处方药、非处方药、保健品或中草药等；
8)筛选前3个月内过量吸烟（≥5支/天）或研究首次服药前48h内吸烟或筛选时烟检阳性，或试验期间不能中断吸烟；
9)既往酗酒【即男性每周饮酒超过28个标准单位，女性每周饮酒超过21个标准单位（1标准单位含14g酒精，如360ml啤酒或45ml酒精量为40%的烈酒或150ml葡萄酒）】，或筛选前3个月内经常饮酒（每周饮酒超过14个标准单位），或筛选时酒精呼气试验结果大于0.0mg/100mL，或研究首次服药前48h内摄入任何含有酒精的食物或饮料（如白酒、啤酒、葡萄酒、米酒、啤酒鸭、豆腐乳、含食用酒精的蛋黄派和瑞士卷等），或试验期间不能中断；
10)既往长期饮过量的含咖啡因饮料（一天8杯以上，1杯=250mL），或研究首次服药前48h内摄入任何含有咖啡因的食物或饮料（如：咖啡、茶、可乐、巧克力等），或试验期间不能中断摄入；
11)研究首次服药前48h内，服用任何葡萄柚水果或含有葡萄柚成分的产品，或试验期间不能中断摄入；
12)对饮食有特殊要求，不能遵守统一饮食；
13)筛选前4周内已经开始了显著不正常的饮食（如节食、低钠）；
14)筛选前3个月内参加过其他临床试验；
15)筛选前1个月内接种过疫苗；
16)筛选前3个月内献血或大量失血（≥200mL）；
17)静脉釆血困难，或不能耐受静脉穿刺，或有晕针晕血史；
研究者认为任何不适宜受试者进入本项试验的其他因素。

Exclusion criteria：

1) Allergies or history of drug or food allergies, or known allergies to voriconazole;
2) Researchers believe that they have clinically meaningful liver, kidney, endocrine, cardiovascular, neurological, mental, gastrointestinal (such as peptic ulcer disease), lung, tumor, immunity, five sense organs, skin, reproduction, blood or metabolism Disorders and other diseases or any other diseases, or have a medical history of these diseases, or have a history of major operations, or factors that will endanger the safety of the subject or affect the results of the study;
3) Physical examination, vital signs measurement, laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function, blood pregnancy (female subjects only), serum virology), 12-lead electrocardiogram test results, the investigator's judgment The abnormality has clinical significance;
4) During the trial period and within 3 months after the end of the study, the subject or his partner has a pregnancy plan or is unwilling to use a medically acceptable method of contraception, or the subject has a sperm/egg donation plan;
5) Pregnant, lactating women, or women of childbearing age who did not take appropriate contraceptive measures within 14 days before joining the group, or who took oral contraceptives within 30 days before the first dose of the study, or used long-acting estrogen or progestin within 3 months before the test Injections or embedded tablets;
6) Have a history of drug abuse, or have a positive drug abuse and drug test, or take any drugs (including Chinese herbal medicine) or functional vitamins habitually;
7) Any prescription drugs, non-prescription drugs, health care products or Chinese herbal medicines have been used in the 14 days before screening;
8) Excessive smoking (≥5 cigarettes/day) within 3 months before screening, or smoking within 48 hours before the first dose of the study, or a positive smoke test during screening, or smoking cannot be interrupted during the trial;
9) Past alcoholism [that is, men drink more than 28 standard units per week, and women drink more than 21 standard units per week (1 standard unit contains 14g of alcohol, such as 360ml of beer or 45ml of 40% alcohol or 150ml of wine) ], or frequent alcohol consumption in the 3 months before screening (more than 14 standard units of alcohol per week), or alcohol breath test results greater than 0.0mg/100mL at the time of screening, or intake of any alcohol-containing food within 48 hours before the first dose of the study Or beverages (such as liquor, beer, wine, rice wine, beer duck, fermented bean curd, egg yolk pie and Swiss rolls with edible alcohol, etc.), or the test period cannot be interrupted;
10) Excessive consumption of caffeine-containing beverages (more than 8 cups a day, 1 cup=250mL) in the past for a long time, or any food or beverages containing caffeine (such as coffee, tea, cola, chocolate) within 48 hours before the first dose of the study Etc.), or the intake cannot be interrupted during the test;
11) Within 48 hours before the first dose of the study, take any grapefruit fruit or products containing grapefruit components, or not interrupt the intake during the test period;
12) There are special requirements for diet and cannot comply with a unified diet;
13) Have started a significantly abnormal diet (such as dieting, low sodium) within 4 weeks before screening;
14) Participated in other clinical trials within 3 months before screening;
15) Vaccination within 1 month before screening;
16) Blood donation or massive blood loss (≥200mL) within 3 months before screening;
17) Difficulty in bleeding veins, or intolerance of venipuncture, or a history of fainting needles and bleeding;
The investigator believes that any other factors that are not suitable for the subject to enter this trial.

研究实施时间：

Study execute time：

从 From 2021-09-13 00:00:00至 To 2021-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2021-09-30 00:00:00 至 To 1990-01-01 00:00:00  

干预措施：

Interventions：

组别：

A组

样本量：

26

Group：

Group A

Sample size：

干预措施：

第一周期给受试制剂，第二周期给参比制剂

干预措施代码：

Intervention：

The test preparation was administered in the first cycle, and the reference preparation was administered in the second cycle

Intervention code：

组别：

B组

样本量：

26

Group：

Group B

Sample size：

干预措施：

第一周期给参比制剂，第二周期给受试制剂

干预措施代码：

Intervention：

The reference preparation was administered in the first cycle, and the test preparation was administered in the second cycle

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 河北 

市(区县)：

 邢台 

Country：

China 

Province：

Hebei 

City：

Xingtai 

单位(医院)：

邢台医学高等专科学校第二附属医院 

单位级别：

三级 

Institution
hospital：

The Second Affiliated Hospital of Xingtai Medical College

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

最大血药浓度

指标类型：

主要指标

Outcome：

maximum blood 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：

从0点到最后一个时间点t的血药浓度—时间曲线下面积

指标类型：

主要指标

Outcome：

the area under the plasma concentration-time curve from 0 to the last time point t

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

从零到无穷大时间内血药浓度-时间曲线下面积

指标类型：

主要指标

Outcome：

area under the plasma concentration-time curve from zero to infinity

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 岁 years
最大 Max age 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）：

随机表由北京百奥知信息科技有限公司应用SAS 9.4（或以上版本）按1:1区组随机产生。

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

The random table is randomly generated by Beijing Baiaozhi Information Technology Co., Ltd. using SAS 9.4 (or above) according to the 1:1 block.

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：

Blinding：

是否共享原始数据：

IPD sharing

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）：

邢台医专第二附属医院

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

The Second Affiliated Hospital of Xingtai Medical College

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：

原始病历的所有数据必须核对，保证无误后签字并注明日期。监查员审核每份原始研究记录表

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

All data in the original medical record must be checked, signed and dated after ensuring that it is correct. The inspector reviews each original research record sheet to confirm that the clinical trial data record is timely, accurate, standardized and complete.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2021-09-15 09:24:49