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比拉斯汀口腔崩解片生物等效性试验
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注册号：

Registration number：

 ChiCTR2500109699 

最近更新日期：

Date of Last Refreshed on：

 2025-09-24 09:15:42 

注册时间：

Date of Registration：

 2025-09-24 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

比拉斯汀口腔崩解片生物等效性试验

Public title：

Bioequivalence test of Bilastine orally disintegrating tablets

注册题目简写：

English Acronym：

研究课题的正式科学名称：

比拉斯汀口腔崩解片在中国健康受试者中单中心、随机、开放、单剂量、两制剂、两周期、两序列、双交叉空腹状态下生物等效性试验

Scientific title：

A single-center, randomized, open-access, single-dose, two-preparation, two-cycle, two-sequence, double-cross fasting bioequivalence trial of Bilastin orally disintegrating tablets in healthy subjects in China

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：

杨辉 

研究负责人：

杨辉 

Applicant：

Yang Hui 

Study leader：

Yang Hui 

申请注册联系人电话：

Applicant telephone：

 +86 13928808723

研究负责人电话：

Study leader's
telephone：

+86 20 34859951

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：

 yanghui1234359@sina.com

研究负责人电子邮件：

Study leader's E-mail：

 yanghui1234359@sina.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：

广州市番禺区桥南街福愉东路8号

研究负责人通讯地址：

广州市番禺区桥南街福愉东路8号

Applicant address：

No. 8, Fuyu East Road, Qiaonan Street, Panyu District, Guangzhou City

Study leader's address：

No. 8, Fuyu East Road, Qiaonan Street, Panyu District, Guangzhou City

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：

广州医科大学附属番禺中心医院

Applicant's institution：

Panyu Central Hospital Affiliated to Guangzhou Medical University

研究负责人所在单位：

广州医科大学附属番禺中心医院

Affiliation of the Leader：

The Affiliated Panyu Central Hospital, Guangzhou Medical 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：

 PYZXYYEC【2025-012（YW）】-02

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：

广州医科大学附属番禺中心医院药物临床试验伦理委员会

Name of the ethic committee：

Drug Clinical Trial Ethics Committee of Panyu Central Hospital Affiliated to Guangzhou Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-04-30 00:00:00

伦理委员会联系人：

冯富肩

Contact Name of the ethic committee：

Feng Fujian

伦理委员会联系地址：

广州市番禺区桥南街福愉东路8号

Contact Address of the ethic committee：

No. 8, Fuyu East Road, Qiaonan Street, Panyu District, Guangzhou City

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 20 34859967

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 531177697@qq.com

研究实施负责（组长）单位：

广州医科大学附属番禺中心医院

Primary sponsor：

The Affiliated Panyu Central Hospital, Guangzhou Medical University

研究实施负责（组长）单位地址：

广州市番禺区桥南街福愉东路8号

Primary sponsor's address：

No. 8, Fuyu East Road, Qiaonan Street, Panyu District, Guangzhou City

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东省

市(区县)：

Country：

China

Province：

Guangdong

City：

单位(医院)：

广州医科大学附属番禺中心医院

具体地址：

广州市番禺区桥南街福愉东路8号

Institution
hospital：

The Affiliated Panyu Central Hospital, Guangzhou Medical University

Address：

No. 8, Fuyu East Road, Qiaonan Street, Panyu District, Guangzhou City

经费或物资来源：

江西施美药业股份有限公司

Source(s) of funding：

Jiangxi Shimei Pharmaceutical Co., LTD

研究疾病：

过敏性鼻炎 荨麻疹 皮肤疾病（湿疹・皮炎、皮肤瘙痒症）伴随的瘙痒  

Target disease：

Allergic rhinitis Urticaria Itching accompanied by skin diseases (eczema, dermatitis, pruritus)

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：

健康受试者空腹状态下，单次口服江西施美药业股份有限公司生产的受试制剂比拉斯汀口腔崩解片（规格：20mg）或大鵬薬品工業株式会社生产的参比制剂比拉斯汀口腔崩解片（商品名：Bilanoa®；规格：20mg），考察空腹状态下受试制剂与参比制剂在健康受试者体内的药代动力学参数，评价两制剂的生物等效性。  

Objectives of Study：

Healthy subjects were given a single oral administration of the test preparation Bilastin Orally Disintegrating Tablets (Specification: 20mg) produced by Jiangxi Shimei Pharmaceutical Co., Ltd. or the reference preparation Bilastin Orally Disintegrating Tablets (trade name: Bilanoa®) produced by Dapeng Pharmaceutical Industry Co., Ltd. on an empty stomach. Specification: 20mg), to investigate the pharmacokinetic parameters of the test preparation and the reference preparation in healthy subjects under fasting conditions, and to evaluate the bioequivalence of the two preparations.

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.已知对任何药物、食物等过敏，或已知对比拉斯汀或其制剂中的辅料过敏，或有特异性变态反应病史（如哮喘、风疹、湿疹性皮炎）或为严重的过敏体质，且经研究者判断有临床意义者；
2.有吞咽困难或影响药物吸收的胃肠道疾病史，如接受过胃或小肠切除术、胆囊切除术等任何可能会影响药物吸收的外科手术史；
3.存在研究医生判定有临床意义的血液循环系统、消化系统、泌尿系统、呼吸系统、神经系统、免疫系统、内分泌系统、精神异常或代谢异常等慢性病史或严重疾病史，或可能干扰试验结果的任何其他疾病，或3个月内的手术史；
4.有QT延长和/或尖端扭转型室速病史（包括先天性长QT综合征病史）；
5.有口干症、唾液分泌异常、口腔溃疡等口腔病史者；
6.肌酐清除率<80mL/min且由临床医师判断为有临床意义者；
7.筛选前30天内使用过任何与比拉斯汀有潜在相互作用的药物【如：OATP1A2 底物或抑制剂（如利托那韦、利福平等）、P-gp 抑制剂或诱导剂（如酮康唑、红霉素、环孢素、利托那韦、地尔硫卓或利福平、苯巴比妥、地塞米松）】（参见方案章节1.2.8）者；
8.血管穿刺条件差，或不能耐受静脉穿刺者，或有晕针晕血史者；
9.筛选前6个月内有药物滥用史者，或筛选前3个月内使用过毒品者，包括非医疗目的反复、大量地使用各类麻醉药品和精神药物，或尿液成瘾药物吗啡、甲基安非他明（冰毒）、氯胺酮、二亚甲基双氧安非他明（摇头丸）、四氢大麻酚酸（大麻）筛查试验任何一项或多项结果为阳性者；
10.筛选前3个月内参加过或正在参加其他的药物临床试验者；
11.筛选前3个月内献血包括成分血或大量失血（≥400mL），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（包括血液成份）者；
12.女性处在妊娠期、哺乳期，或女性在计划给药前14天内有未保护性行为或血妊娠检查结果阳性者；
13.筛选前14天内使用过任何处方药、非处方药、中草药和维生素者；
14.筛选前3个月内接受过疫苗接种者，或计划在试验期间接种疫苗者；
15.筛选前3个月内每日吸烟量大于5支，或试验期间不能停止使用任何烟草类产品者；
16.筛选前3个月内酒精摄入量平均每天超过2个单位（1单位=360mL啤酒，或150mL红酒，或45mL蒸馏酒），或酒精测试阳性者，或不同意在试验期间避免饮酒者；
17.乳糖不耐受、乳糖酶缺乏或葡萄糖-半乳糖吸收不良病史者；
18.给药前 48h 内摄取了含咖啡因、酒精类等饮料（包括巧克力、茶、咖啡、可乐等） ，食用葡萄柚或葡萄柚产品以及火龙果、芒果、柚子、橘子等影响药物代谢的食物者；
19.对饮食有特殊要求，不能接受统一饮食（如不能耐受牛奶、鸡蛋、黄油、培根等食物）者；
20.无法在试验期间避免驾驶或操作机器者；
21.在研究前筛选阶段或研究用药前发生急性疾病者；
22.研究者认为不适宜入组或受试者因个人原因无法参加试验者；

Exclusion criteria：

1.Those who are known to be allergic to any drug, food, etc., or are known to be allergic to the excipients in contrast lastin or its preparations, or have a history of specific allergic reactions (such as asthma, rubella, eczematous dermatitis), or have a severe allergic constitution, and have been determined by researchers to have clinical significance; 2.There is a history of dysphagia or gastrointestinal diseases that affect drug absorption, such as having undergone any surgical procedures that may affect drug absorption, such as gastrectomy or small intestinal resection, cholecystectomy, etc; 3.There is a history of chronic or serious diseases such as the circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, mental or metabolic disorders, or any other diseases that may interfere with the test results, as determined by the research doctor to be clinically significant, or a surgical history within 3 months; 4.A history of QT prolongation and/or torsional ventricular tachycardia at the tip (including a history of congenital long QT syndrome); 5.Those with a history of oral diseases such as dry mouth, abnormal salivary secretion, and oral ulcers; 6.Those with a creatinine clearance rate of less than 80mL/min and judged as clinically significant by clinicians; 7.Have used any drugs that have potential interactions with bilastin within 30 days before screening [such as: OATP1A2 substrates or inhibitors (such as ritonavir, rifampicin), P-gp inhibitors or inducers (such as ketoconazole, erythromycin, cyclosporine, ritonavir, diltiazepine or rifampicin, phenobarbital, dexamethasone) (see Protocol Section 1.2.8); 8.Those with poor conditions for vascular puncture, or those who cannot tolerate venipuncture, or those with a history of fainting from needles or blood; 9.Those who have a history of drug abuse within 6 months before screening, or those who have used drugs within 3 months before screening, including repeated and large-scale use of various narcotic drugs and psychotropic substances for non-medical purposes, Or those whose screening tests for any one or more of the urine addiction drugs such as morphine, methamphetamine (methamphetamine), ketamine, dimethylenedioxyamphetamine (ecstasy), and tetrahydrocannabinic acid (cannabis) are positive; 10.Those who have participated in or are currently participating in other drug clinical trials within the three months prior to the screening; 11.Those who have donated blood within 3 months before screening, including component blood or significant blood loss (≥400mL), received blood transfusion or used blood products; Or those who plan to donate blood (including blood components) during the trial or within 3 months after the end of the trial; 12.Women who are in the pregnancy or lactation period, or who have had unprotected sex or positive blood pregnancy test results within 14 days before the planned administration of the drug; 13.Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines and vitamins within 14 days before screening; 14.Those who have received vaccination within the three months prior to screening, or those who plan to receive vaccination during the trial; 15.Those who smoked more than 5 cigarettes per day within 3 months before screening, or were unable to stop using any tobacco products during the trial period; 16.Those who consumed an average of more than 2 units of alcohol per day within 3 months before screening (1 unit =360mL of beer, or 150mL of red wine, or 45mL of distilled spirit), or had a positive alcohol test result, or did not intend to avoid alcohol during the trial period; 17.Those with a history of lactose intolerance, lactase deficiency or glucose-galactose malabsorption; 18.Those who consumed beverages containing caffeine, alcohol, etc. (including chocolate, tea, coffee, cola, etc.) within 48 hours before administration, or ate grapefruit or grapefruit products, as well as foods that affect drug metabolism such as pitaya, mango, pomelo, and orange; 19.Those who have special dietary requirements and cannot accept a uniform diet (such as milk, eggs, butter, bacon and other foods); 20.Those who are unable to avoid driving or operating the machine during the test; 21.Those who developed acute diseases during the screening stage before the study or before the study of medication; 22.Those who are considered unsuitable for enrollment by the researchers or whose subjects are unable to participate in the trial due to personal reasons.

研究实施时间：

Study execute time：

从 From 2025-07-11 00:00:00至 To 2025-07-26 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-07-13 00:00:00 至 To 2025-07-14 00:00:00

干预措施：

Interventions：

组别：

R-T 组

样本量：

 18

Group：

GROUP R-T

Sample size：

干预措施：

第一周期受试者空腹口服参比制剂（R）20mg（1片），7天后受试者空腹口服受试制剂（T）20mg（1片）。

干预措施代码：

Intervention：

In the first cycle, the subjects took the reference formulation (R) 20mg (1 tablet) orally while fasting, and after 7 days, the subjects took the test formulation (T) 20mg (1 tablet) orally while fasting.

Intervention code：

组别：

T-R组

样本量：

 18

Group：

GROUP T-R

Sample size：

干预措施：

第一周期受试者空腹口服受试制剂（T）20mg（1片），7天后受试者空腹口服参比制剂（R）20mg（1片）。

干预措施代码：

Intervention：

In the first cycle, the subjects took the test formulation (T) 20mg (1 tablet) orally while fasting, and after 7 days, the subjects took the reference formulation (R) 20mg (1 tablet) orally while fasting.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

  

Country：

China

Province：

Guangdong

City：

单位(医院)：

 广州医科大学附属番禺中心医院 

单位级别：

 三级甲等 

Institution
hospital：

The Affiliated Panyu Central Hospital, Guangzhou Medical 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：

2周期血样采集后

测量方法：

采用LC-MS/MS法测定

Measure time point of outcome：

After two cycles of blood sample collection

Measure method：

Determination using LC-MS/MS method

指标中文名：

从0时到最后一个浓度可准确测定的样品采集时间t的药物浓度-时间曲线下面积

指标类型：

主要指标

Outcome：

AUC0-t

Type：

Primary indicator

测量时间点：

2周期血样采集后

测量方法：

采用LC-MS/MS法测定

Measure time point of outcome：

After two cycles of blood sample collection

Measure method：

Determination using LC-MS/MS method

指标中文名：

从0时到无限时间（∞）的药物浓度-时间曲线下面积

指标类型：

主要指标

Outcome：

AUC0-∞

Type：

Primary indicator

测量时间点：

2周期血样采集后

测量方法：

采用LC-MS/MS法测定

Measure time point of outcome：

After two cycles of blood sample collection

Measure method：

Determination using LC-MS/MS 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：

结束

/Completed

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）：

由统计单位应用SAS（9.4或更高版本）用区组随机法生成随机分配表

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

Generate a random allocation table using block randomization method using SAS (version 9.4 or higher) applied by statistical units.

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

Blinding：

Open-label study

是否共享原始数据：

IPD sharing

是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）：

论文发表后一年内，国家生物信息中心 https://ngdc.cncb.ac.cn/gsa

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

Within one year of publication, China Nation center for Bioinformation https://ngdc.cncb.ac.cn/gsa

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：

电子采集和管理系统和病历报告表

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

EDC and CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-09-24 09:15:30
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