ChiCTR2600119502 版本V1.0 版本创建时间2026/02/28 08:51:38 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：

ChiCTR2600119502 

最近更新日期：

Date of Last Refreshed on：

2026-02-28 08:51:28 

注册时间：

Date of Registration：

2026-02-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

盐酸曲唑酮缓释片在中国健康研究参与者中空腹或餐后状态下随机、开放、单剂量、两序列、两周期、交叉生物等效性研究

Public title：

A Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover Bioequivalence Study of Trazodone Hydrochloride Extended-Release Tablets in Chinese Healthy Subjects Under Fasting and Fed Conditions

注册题目简写：

English Acronym：

研究课题的正式科学名称：

盐酸曲唑酮缓释片在中国健康研究参与者中空腹或餐后状态下随机、开放、单剂量、两序列、两周期、交叉生物等效性研究

Scientific title：

A Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover Bioequivalence Study of Trazodone Hydrochloride Extended-Release Tablets in Chinese Healthy Subjects Under Fasting and Fed Conditions

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：

郭风雪 

研究负责人：

郭风雪 

Applicant：

Fengxue Guo 

Study leader：

Fengxue Guo 

申请注册联系人电话：

Applicant telephone：

+86 319 2279912

研究负责人电话：

Study leader's telephone：

+86 319 2279896

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：

fxguo2023@163.com

研究负责人电子邮件：

Study leader's E-mail：

fxguo0266@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：

河北省邢台市钢铁北路618号

研究负责人通讯地址：

河北省邢台市钢铁北路618号

Applicant address：

No. 618, Gangtie North Road, Xindu District, Xingtai City.

Study leader's address：

No. 618, Gangtie North Road, 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：

邢台医学院第二附属医院（邢台市肿瘤医院）

Applicant's institution：

The Second Affiliated Hospital of Xingtai Medical College

研究负责人所在单位：

邢台医学院第二附属医院

Affiliation of the Leader：

The Second Affiliated Hospital Of Xingtai Medical College

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：

2025-019-01

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：

邢台医学院第二附属医院（邢台市肿瘤医院）临床试验伦理委员会

Name of the ethic committee：

The Clinical Trial Ethics Committee of the Second Affiliated Hospital of Xingtai Medical University (Xingtai Cancer Hospital)

伦理委员会批准日期：

Date of approved by ethic committee：

2025-12-22 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：

河北省邢台市钢铁北路618号

Contact Address of the ethic committee：

No. 618, Gangtie North Road, Xingtai, Hebei

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 319 2279916

伦理委员会联系人邮箱：

Contact email of the ethic committee：

liuzhenfang.1983@163.com

研究实施负责（组长）单位：

邢台医学院第二附属医院

Primary sponsor：

The Second Affiliated Hospital Of Xingtai Medical College

研究实施负责（组长）单位地址：

河北省邢台市钢铁北路618号

Primary sponsor's address：

No. 618, Gangtie North Road, 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)：

河北省

市(区县)：

Country：

China

Province：

Hebei

City：

单位(医院)：

邢台医学院第二附属医院

具体地址：

河北省邢台市钢铁北路618号

Institution
hospital：

The Second Affiliated Hospital Of Xingtai Medical College

Address：

No. 618, Gangtie North Road, Xingtai, Hebei

经费或物资来源：

河北龙海药业有限公司

Source(s) of funding：

Hebei Longhai Pharmaceutical Co Ltd

Target disease：

Depression

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：健康研究参与者在空腹或餐后状态下，单次口服盐酸曲唑酮缓释片受试制剂（规格：75mg，河北龙海药业有限公司）与参比制剂（曲特恪? TRITTICO?，规格：75mg，Az.Chim.Riun.AngeliniFrancescoAcrafS.P.A.生产）后，比较两制剂在体内血药浓度及主要药代动力学参数，评价两制剂的生物等效性。 次要目的：评价两制剂在健康研究参与者中空腹或餐后状态下的安全性。  

Objectives of Study：

Primary Objective:?To compare the plasma concentrations and key pharmacokinetic parameters of the test product (Trazodone Hydrochloride Extended-Release Tablets, 75 mg, manufactured by Hebei Longhai Pharmaceutical Co., Ltd.) and the reference product (Trittico? TRITTICO?, 75 mg, manufactured by Az.Chim.Riun.AngeliniFrancescoAcrafS.P.A.) after a single oral dose in Chinese healthy subjects under fasting or fed conditions, and to evaluate the bioequivalence between the two formulations.Secondary Objective:?To assess the safety of both formulations in Chinese healthy subjects under fasting or 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：

1.研究参与者充分了解试验目的、性质、方法以及可能发生的不良反应，自愿作 为研究参与者，并签署经伦理委员会批准的知情同意书； 2.年龄18周岁以上（包括18周岁）的健康研究参与者（男女均可）； 3.男性体重≥50.0kg，女性体重≥45.0kg；体重指数（BMI）在19.0~26.0kg/m^2范围内 （包括临界值）； 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。

Inclusion criteria

1.Subjects must fully understand the study objectives, nature, procedures, and potential adverse reactions, voluntarily agree to participate as study subjects, and sign the informed consent form approved by the Ethics Committee. 2.Healthy male or female subjects aged 18 years or older. 3.Healthy male or female subjects with a body weight of >=50.0 kg (male) or >=45.0 kg (female) and a body mass index (BMI) between 19.0 and 26.0 kg/m^2 (inclusive). 4.Subjects must be able to communicate effectively with the investigator and understand and comply with all study requirements.

排除标准：

1.生命体征、实验室检查（血常规、血生化、尿常规、凝血功能）、体格检查、12 导联心电图，研究者判断结果异常有临床意义者； 2.血清病毒学任何一项研究者认为异常有临床意义者； 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、肌肉骨骼系统等上述系统的慢性/严重疾病或疾病 史（如癫痫、肝肾损害、心脏病、甲状腺功能亢进、排尿障碍、急性狭角青光眼 等）/治疗史（如接受过电休克疗法），且研究医生判断异常有临床意义者； 4.筛选前6个月内接受过外科手术、病理活检或遭受严重外伤或计划在试验期间进 行手术者，以及凡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； 5.有体位性低血压病史或体位性低血压者；或筛选期出现体位性低血压者（测量方 法见附录1）； 6.筛选前2周内使用过任何处方药、非处方药和保健品者； 7.筛选前1个月内使用过可能与试验用药物有相互作用的药物：红霉素、酮康唑、 伊曲康唑、沙奎那韦、利托那韦、茚地那韦、奈法唑酮、卡马西平、巴比妥类、 西咪替丁、氟西汀、氯丙嗪、氟奋乃静、左美丙嗪、奋乃静、左旋多巴、可乐定、 华法林、地高辛、苯妥英、含贯叶连翘的药物、三环类抗抑郁药物、单胺氧化酶 抑制剂、麻醉药/肌肉松弛药、延长QT间期的药物者； 8.筛选前1个月内接受过疫苗接种者，或者计划在研究期间进行疫苗接种者； 9.筛选前1年内有药物滥用史或使用过毒品或尿液药物筛查阳性者； 10.有食物或药物过敏史（哮喘、荨麻疹、湿疹、过敏性休克等），或过敏体质，或 对本品任何成分（曲唑酮、蔗糖、聚维酮、棕榈蜡、硬脂酸镁）过敏者； 11.筛选前3个月内献血或大量失血（≥400mL），或接受输血或血液制品者； 12.筛选前2周内发生无保护性行为；或整个试验期间以及试验结束后6个月内有妊娠 或捐精捐卵计划，或不愿意采取有效避孕措施； 13.女性研究参与者处在妊娠期或哺乳期；或筛选前1个月内使用过口服避孕药；或 筛选前6个月内使用过长效雌激素或孕激素注射剂或埋植片或活性避孕环者；或 妊娠检查异常有临床意义者； 14.筛选前3个月内每天饮用茶、咖啡和/或含咖啡因的饮料者，或试验期间不能停止 饮用者；或服药前48h内食用过富含咖啡因（如茶、巧克力、咖啡）或富含嘌呤 （如动物内脏、海产品）的食物或饮料，或其他影响药物吸收、分布、代谢、排 泄的食物者； 15.服药前7天内摄入可能影响代谢酶的饮食（如火龙果、芒果、葡萄柚等）者； 16.对饮食有特殊要求，或不能遵守统一饮食（标准餐、高脂餐）者； 17.遗传性果糖不耐受症、葡萄糖-半乳糖吸收不良、蔗糖酶-异麦芽糖酶缺陷、乳糖 不耐受（喝牛奶腹泻）者； 18.筛选前3个月内过量饮酒者，即每周饮酒超过14单位酒精（1单位=360mL啤酒或 45mL酒精量为40%的烈酒或150mL葡萄酒）；或服药前48h内服用过任何含酒精 的制品，或酒精呼气测试结果>0mg/100mL者；或不能在试验期间停止饮用者； 19.筛选前3个月内每日吸烟量>5支或试验期间不能停止使用任何烟草类产品者； 20.筛选前3个月内参加过其它药物临床试验或器械临床试验，并服用了试验药物或 使用了试验器械者；或证件照与本人不符者； 21.有晕针、晕血史，静脉采血困难和/或不能耐受静脉穿刺/留置针者； 22.有吞咽困难者； 23.试验期间计划从事高空作业、驾驶机动车辆、操作复杂仪器者； 24.研究参与者因自身原因不能参加试验者； 25.研究者判定的其他任何不适宜参加试验的情况。

Exclusion criteria：

1.Subjects with abnormal vital signs, laboratory tests (complete blood count, blood biochemistry, urinalysis, coagulation function), physical examination, or 12-lead ECG that are judged by the investigator to be clinically significant. 2.Subjects with any abnormality in serology virology test results that are judged by the investigator to be clinically significant. 3.Subjects with any chronic or severe diseases or a history of diseases (e.g., epilepsy, hepatic or renal impairment, cardiac disease, hyperthyroidism, urinary retention, acute narrow-angle glaucoma, etc.) in the endocrine, urinary, digestive, hematologic and lymphatic, respiratory, cardiovascular, nervous, psychiatric, or musculoskeletal systems, as well as a history of relevant treatments (e.g., electroconvulsive therapy), which are judged by the investigator to be clinically significant. 4.Subjects who have undergone surgery, biopsy, or experienced severe trauma within the 6 months prior to screening, or who plan to undergo surgery during the trial, as well as those with any surgical history judged by the investigator to potentially affect drug absorption, distribution, metabolism, or excretion. 5.Subjects with a history of orthostatic hypotension, currently experiencing orthostatic hypotension, or those found to have orthostatic hypotension during screening (measurement method as per Appendix 1). 6.Subjects who have used any prescription drugs, over-the-counter medications, or health supplements within 2 weeks prior to screening. 7.Subjects who have used drugs that may potentially interact with the investigational drug within 1 month prior to screening, including but not limited to: erythromycin, ketoconazole, itraconazole, saquinavir, ritonavir, indinavir, nefazodone, carbamazepine, barbiturates, cimetidine, fluoxetine, chlorpromazine, fluphenazine, levomepromazine, perphenazine, levodopa, clonidine, warfarin, digoxin, phenytoin, preparations containing St. John's wort (Hypericum perforatum), tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), narcotics/muscle relaxants, and drugs that prolong the QT interval. 8.Subjects who have received any vaccination within 1 month prior to screening, or who plan to receive a vaccination during the study period. 9.Subjects with a history of drug abuse within the past year, those who have used illicit drugs, or those with a positive urine drug screen. 10.Subjects with a history of food or drug allergy (e.g., asthma, urticaria, eczema, anaphylactic shock, etc.), or allergic constitution, or those allergic to any component of the study drug (e.g., trazodone, sucrose, povidone, carnauba wax, magnesium stearate, etc.). 11.Subjects who have donated blood or experienced significant blood loss (>=400 mL), or received blood transfusions or blood products within 3 months prior to screening. 12.Subjects who have engaged in unprotected sexual activity within 2 weeks prior to screening; or who plan to become pregnant, donate sperm, or donate eggs during the entire study period and for 6 months after the trial, or are unwilling to use effective contraception. 13.Female subjects who are pregnant or breastfeeding; or who have used oral contraceptives within 1 month prior to screening; or who have used long-acting estrogen/progesterone injections, implants, or active contraceptive devices within 6 months prior to screening; or whose pregnancy test results are abnormal and judged to be clinically significant. 14.Subjects who have consumed tea, coffee, and/or caffeinated beverages daily within 3 months prior to screening, or are unable to abstain from such consumption during the trial; or who have consumed foods or beverages rich in caffeine (e.g., tea, chocolate, coffee) or purine (e.g., animal offal, seafood), or any other substances that may affect drug absorption, distribution, metabolism, or excretion, within 48 hours prior to dosing. 15.Subjects who have consumed foods that may affect metabolic enzymes (e.g., pitaya, mango, grapefruit, etc.) within 7 days prior to dosing. 16.Subjects with specific dietary requirements or those who are unable to comply with the standardized diets (standard meal, high-fat meal) provided in the study. 17.Subjects with hereditary fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase deficiency, or lactose intolerance (e.g., diarrhea after milk consumption). 18.Subjects who consumed excessive alcohol within 3 months prior to screening (defined as >14 units of alcohol per week, where 1 unit = 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine); or those who consumed any alcohol-containing products within 48 hours prior to dosing, or had a positive alcohol breath test result (>0 mg/100 mL); or who are unable to abstain from alcohol during the trial. 19.Subjects who smoked more than 5 cigarettes per day within 3 months prior to screening or are unable to abstain from using any tobacco products during the trial. 20.Subjects who have participated in other drug or device clinical trials within 3 months prior to screening and have taken the investigational drug or used the investigational device, or whose identification photo does not match their appearance. 21.Subjects with a history of needle or blood phobia (syncope or vasovagal reactions related to needles or blood), difficulty with venous blood collection, and/or inability to tolerate venipuncture or indwelling catheter placement. 22.Subjects with dysphagia. 23.Subjects who plan to engage in high-altitude work, operate motor vehicles, or handle complex machinery during the trial period. 24.Subjects who are unable to participate in the trial due to personal reasons. 25.Any other condition deemed by the investigator to be unsuitable for participation in the trial.

研究实施时间：

Study execute time：

从 From 2026-03-23 00:00:00至 To 2026-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-03-23 00:00:00 至 To 2026-08-31 00:00:00  

干预措施：

Interventions：

组别：

餐后试验TR序列组

样本量：

20

Group：

TR Sequence Group in the Fed Study

Sample size：

干预措施：

第一周期餐后口服受试制剂 T（1 片）；第二周期空腹或餐后口服参比制剂 R（1 片）；清洗期 7 天

干预措施代码：

Intervention：

In the first cycle, take the test formulation T (1 tablet) after meals; in the second cycle, take the reference formulation R (1 tablet) on an empty stomach or after meals; washout period of 7 days.

Intervention code：

组别：

空腹试验RT序列组

样本量：

18

Group：

RT Sequence Group in the Fasting Study

Sample size：

干预措施：

第一周期空腹口服参比制剂 R（1 片）；第二周期空腹或餐后口服受试制剂 T（1 片）；清洗期 7 天

干预措施代码：

Intervention：

In the first cycle, take the reference formulation R (1 tablet) on an empty stomach; in the second cycle, take the test formulation T (1 tablet) on an empty stomach or after a meal; 7-day washout period

Intervention code：

组别：

空腹试验TR序列组

样本量：

18

Group：

TR Sequence Group in the Fasting Study

Sample size：

干预措施：

第一周期餐后口服受试制剂 T（1 片）；第二周期空腹或餐后口服参比制剂 R（1 片）；清洗期 7 天

干预措施代码：

Intervention：

In the first cycle, take the test formulation T (1 tablet) after meals; in the second cycle, take the reference formulation R (1 tablet) on an empty stomach or after meals; washout period of 7 days.

Intervention code：

组别：

餐后试验RT序列组

样本量：

20

Group：

RT Sequence Group in the Fed Study

Sample size：

干预措施：

第一周期餐后口服参比制剂 R（1 片）；第二周期空腹或餐后口服受试制剂 T（1 片）；清洗期 7 天

干预措施代码：

Intervention：

In the first cycle, take the reference formulation R (1 tablet) after meals; in the second cycle, take the test formulation T (1 tablet) on an empty stomach or after meals; washout period of 7 days.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 河北省 

市(区县)：

  

Country：

China 

Province：

Hebei 

City：

 

单位(医院)：

邢台医学院第二附属医院 

单位级别：

三级医院 

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：

血浆药物达峰浓度（空腹试验）

指标类型：

主要指标

Outcome：

Maximum Plasma Concentration (Fasting Test)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

从给药0h到最后一个可准确检测的血药浓度的时间内曲线下面积（空腹试验）

指标类型：

主要指标

Outcome：

Concentration-Time Curve from 0 to the Last Measurable Concentration (Fasting Test)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

从给药0h到外推至无穷远时间的曲线下面积（空腹试验）

指标类型：

主要指标

Outcome：

Area Under the Plasma Concentration-Time Curve from 0 to Infinity (Fasting Test)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血浆药物达峰浓度（餐后试验）

指标类型：

主要指标

Outcome：

Maximum Plasma Concentration (Postprandial Test)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

从给药0h到最后一个可准确检测的血药浓度的时间内曲线下面积（餐后试验）

指标类型：

主要指标

Outcome：

Concentration-Time Curve from 0 to the Last Measurable Concentration (Postprandial Test)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

从给药0h到外推至无穷远时间的曲线下面积（餐后试验）

指标类型：

主要指标

Outcome：

Area Under the Plasma Concentration-Time Curve from 0 to Infinity (Postprandial Test)

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 18 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 由统计单位应用 SAS（9.4 或更高版本）随机产生。

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

Generated by the statistical unit using SAS (version 9.4 or higher).

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

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：

本次试验数据管理采用电子化数据管理系统。eCRF中的数据来自于原始病历和实验室检查报告单原始文件并应与原始文件一致。

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

For this study, an electronic data management system is employed. The data entered into the electronic case report form (eCRF) are sourced from original medical records and laboratory test reports and must be consistent with these original source documents.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-02-28 08:51:28