ChiCTR2600119848 版本V1.0 版本创建时间2026/03/04 14:27:23 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：

 ChiCTR2600119848 

最近更新日期：

Date of Last Refreshed on：

 2026-03-04 14:27:12 

注册时间：

Date of Registration：

 2026-03-04 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

盐酸米诺环素胶囊（50mg）在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、两周期、交叉生物等效性试验

Public title：

A randomized, open-access, single-dose, two-sequence, two-cycle, cross-bioequivalence trial of minocycline Hydrochloride Capsules (50mg) under fasting and postprandial administration conditions in healthy subjects in China

注册题目简写：

English Acronym：

研究课题的正式科学名称：

盐酸米诺环素胶囊（50mg）在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、两周期、交叉生物等效性试验

Scientific title：

A randomized, open-label, single-dose, two-sequence, two-period, crossover bioequivalence study of minocycline hydrochloride capsules (50mg) under 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：

郑思超 

研究负责人：

郑思超 

Applicant：

Zheng Sichao 

Study leader：

Zheng Sichao 

申请注册联系人电话：

Applicant telephone：

 +86 20 85959124

研究负责人电话：

Study leader's
telephone：

+86 20 85959124

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：

 zhengsichao1988@163.com

研究负责人电子邮件：

Study leader's E-mail：

 931672695@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：

广东省广州市黄埔区港湾路621号

研究负责人通讯地址：

广东省广州市黄埔区港湾路621号

Applicant address：

No. 621, Gangwan Road, Huangpu District, Guangzhou City, Guangdong Province

Study leader's address：

No. 621, Gangwan Road, Huangpu District, Guangzhou City, Guangdong 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：

广州医科大学附属第五医院

Applicant's institution：

The Fifth Affiliated Hospital of Guangzhou Medical University

研究负责人所在单位：

广州医科大学附属第五医院

Affiliation of the Leader：

The Fifth Affiliated Hospital of 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：

 GYWY-Y2025-75

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：

广州医科大学附属第五医院伦理委员会

Name of the ethic committee：

The Fifth Affiliated Hospital of Guangzhou Medical University Ethics Committee

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：

周绮汶

Contact Name of the ethic committee：

Zhou Qiwen

伦理委员会联系地址：

广东省广州市黄埔区港湾路621号

Contact Address of the ethic committee：

No. 621, Gangwan Road, Huangpu District, Guangzhou City, Guangdong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 20 85959127

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 GYWYLLWYH@126.com

研究实施负责（组长）单位：

广州医科大学附属第五医院

Primary sponsor：

The Fifth Affiliated Hospital of Guangzhou Medical University

研究实施负责（组长）单位地址：

广东省广州市黄埔区港湾路621号

Primary sponsor's address：

No. 621, Gangwan Road, Huangpu District, Guangzhou City, Guangdong 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)：

广东省

市(区县)：

Country：

China

Province：

Guangdong

City：

单位(医院)：

广州医科大学附属第五医院

具体地址：

广东省广州市黄埔区港湾路621号

Institution
hospital：

The Fifth Affiliated Hospital of Guangzhou Medical University

Address：

No. 621, Gangwan Road, Huangpu District, Guangzhou City, Guangdong Province

经费或物资来源：

无

Source(s) of funding：

Self-selected topic (self-funded)

研究疾病：

无  

Target disease：

None

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：

主要目的：本试验以石家庄康力药业有限公司提供的盐酸米诺环素胶囊（规格：50mg）为受试制剂，以Pfizer Japan Inc.持证的盐酸米诺环素胶囊（商品名：Minomycin?、规格：50mg）为参比制剂，评估受试制剂和参比制剂在空腹和餐后条件下的生物等效性。 次要目的：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：

1.The primary objective: This trial uses the Minocycline Hydrochloride Capsules (specification: 50mg) provided by Shijiazhuang Kangli Pharmaceutical Co., Ltd. as the test formulation, and the Minocycline Hydrochloride Capsules (trade name: Minomycin?; specification: 50mg) held by Pfizer Japan Inc. as the reference formulation to evaluate the bioequivalence of the test and reference formulations under fasting and postprandial conditions. 2.The secondary objective: To observe the safety of the test and reference formulations 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.充分了解试验目的、性质、方法以及可能发生的不良反应，自愿作为受试者，并在任何研究程序开始前由本人签署知情同意书且保证在整个试验过程中由本人参与试验； 2.年龄为18周岁及以上（包含18周岁）的健康男性或女性； 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，BMI=体重（kg）/身高^2（m^2））； 4.筛选至试验结束后3个月内自愿采取有效避孕措施进行避孕（包括受试者伴侣），且未来3个月内无生育计划或捐精、捐卵计划者； 5.承诺无精神障碍病史、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者。

Inclusion criteria

1. Fully understand the purpose, nature, methods of the trial, and possible adverse reactions, voluntarily participate as a subject, and sign the informed consent form personally before any research procedures begin, ensuring participation throughout the entire trial; 2. Healthy male or female aged 18 years or older (including 18 years old); 3. Male weight >= 50.0 kg, female weight >= 45.0 kg; Body Mass Index (BMI) within the range of 19.0~26.0 kg/m^2 (including boundary values, BMI = weight (kg) / height^2 (m^2)); 4. Voluntarily take effective contraception within 3 months from screening to the end of the trial (including the subject's partner), and have no plans for pregnancy, sperm donation, or egg donation in the next 3 months; 5. Commit to having no history of mental disorders, be able to communicate well with the researchers, and understand and comply with all requirements of this study.

排除标准：

1)对米诺环素或制剂辅料过敏者，或已知对任何药物、食物等过敏，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)有吞咽困难或任何影响药物吸收的胃肠道疾病史者；
3)存在任何血液循环系统、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、精神异常等任何慢性或严重疾病史，或可能干扰试验结果的任何其他疾病，或既往有较大的胃肠道手术史（比如：胃切除术、胃肠吻合术、肠切除术、胃旁路术、胃分割术或胃囊带术、胆囊切除术，但阑尾炎手术和脱肛手术除外），或筛选前3个月内有任何可能影响试验安全或药物体内过程的手术史、外伤史，或计划研究期间手术者；
4)有晕血、晕针史或不能耐受静脉穿刺者；
5)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；
6)筛选前3个月内参加过或正在参加其他的药物或医疗器械临床试验，并使用了试验药物或医疗器械干预者；
7)筛选前3个月内献血包括成分血或大量失血（≥400mL），或接受输血或使用血制品，或计划在试验期间或试验结束后3个月内献血（包括血液成份）者；
8)筛选前28天内使用过任何处方药、非处方药、中草药和维生素者；
9)筛选前3个月内使用过任何与米诺环素有相互作用的药物【如：钙、镁、铝、镧、铁剂、抗凝血剂、降血脂药物如考来烯胺或考来替泊、全麻药甲氧氟烷、青霉素类、强利尿药(如呋塞米等)、其他肝毒性药物(如抗肿瘤化疗药物)、麦角生物碱、异维甲酸或其他系统性类视黄 醇或维生素A等】者；
10)筛选前3个月内接种过疫苗者，或计划在试验期间接种疫苗者；
11)筛选前3个月内每日吸烟量大于等于5支，或试验期间不能停止使用任何烟草类产品者；
12)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），或不同意在试验期间避免饮酒者；
13)在筛选前3个月内每天饮用过量浓茶、咖啡和/或含咖啡因的饮料（8杯以上，1杯=250mL）；
14)不能保证服药前48h内禁食浓茶、巧克力、咖啡或含咖啡因、含酒精、含黄嘌呤（如凤尾鱼、沙丁鱼、牛肝、牛肾等）、葡萄柚（汁）或西柚（汁）、橙子、火龙果、芒果、酸橙、杨桃的食物或饮料，或不能停止剧烈运动者；
15)对饮食有特殊要求，不能接受统一饮食者；
16)女性处在妊娠期、哺乳期，或女性在试验前14天内有未保护性行为；
17)女性筛选前6个月内使用过长效雌激素和/或孕激素注射剂和/或埋植片或筛选前30天内使用过口服避孕药者；
18)女性血妊娠检查总β人绒毛膜促性腺激素（β-HCG）检查结果阳性者；
19)在研究前筛选阶段或研究用药前发生急性疾病者（备注：经研究者判断可能影响试验者。）；
20)体格检查、生命体征、实验室检查（血常规、尿常规、血生化、凝血功能、游离甲状腺功能三项）、12导联心电图检查，结果显示异常有临床意义者；
21)传染病筛查（乙肝表面抗原定量、丙肝抗体、HIV抗原和抗体、梅毒螺旋体抗体）任何一项或多项检查结果为阳性者；
22)酒精呼气检测结果＞0 mg/100 mL者；
23)药物滥用筛查任何一项或多项结果为阳性者；
24)其它研究者判定不适宜参加本项临床研究的受试者或因为其他原因不能完成研究而主动退出的受试者。

Exclusion criteria：

1. Individuals who are allergic to minocycline or formulation excipients, or who have known hypersensitivity to any drug, food, etc., or who have a history of atopic allergic reactions (e.g., asthma, rubella, eczematous dermatitis) or who are severe allergic sensitizers that, in the judgment of the investigator, are clinically significant; 2. Those with a history of dysphagia or any gastrointestinal disorder that interferes with drug absorption; 3. History of any chronic or serious disease of any circulatory, digestive, urinary, respiratory, neurologic, immune, endocrine, or psychiatric abnormality, or any other disease that may interfere with the test results, or history of prior major gastrointestinal surgery (e.g., gastrectomy, gastrointestinal anastomosis, enterotomy, gastric bypass, gastric division or gastric cystic banding, cholecystectomy , with the exception of appendicitis surgery and prolapse surgery), or any history of surgery within 3 months prior to screening, trauma that may affect the safety of the trial or the in vivo course of the drug, or surgery during the planned study; 4. Those with a history of blood or needle sickness or those who cannot tolerate venipuncture; 5. Persons with a history of substance abuse within 6 months prior to screening, or persons who have used drugs within 3 months prior to screening, including repeated and heavy use of all types of narcotic drugs and psychotropic substances for non-medical purposes; 6. Those who have participated or are participating in other clinical trials of drugs or medical devices in the 3 months prior to screening and who have utilized a trial drug or medical device intervention; 7. Those who have donated blood including blood components or significant blood loss (≥400mL) within 3 months prior to screening, or who have received a blood transfusion or used blood products, or who plan to donate blood (including blood components) during the trial or within 3 months after the trial is completed; 8. Those who have used any prescription drugs, over-the-counter drugs, herbs and vitamins within 28 days prior to screening; 9. Use of any drug that interacts with minocycline within 3 months prior to screening [e.g., calcium, magnesium, aluminum, lanthanum, iron, anticoagulants, lipid-lowering drugs such as colestipol or colestipol, general anesthetics methoflurane, penicillins, strong diuretics (e.g., furosemide, etc.), other hepatotoxic drugs (e.g., antitumor chemotherapeutic agents), ergot alkaloids, isotretinoin, or other systemic classes of retinoids or vitamin A etc.] persons; 10. Those who have been vaccinated within 3 months prior to screening or who plan to be vaccinated during the trial; 11. Those who smoked greater than or equal to 5 cigarettes per day in the 3 months prior to screening, or who were unable to stop using any tobacco-based products during the trial; 12. Those whose alcohol intake averaged more than 2 units per day (1 unit = 360mL of beer, or 150mL of wine, or 45mL of distilled spirits) in the 3 months prior to screening, or who did not agree to avoid alcohol during the trial; 13. Excessive daily consumption of strong tea, coffee, and/or caffeinated beverages (more than 8 cups, 1 cup = 250mL) in the 3 months prior to screening; 14. Those who cannot guarantee that they will abstain from eating strong tea, chocolate, coffee or food or drinks containing caffeine, alcohol, xanthines (such as anchovies, sardines, beef liver, beef kidney, etc.), grapefruit (juice) or grapefruit (juice), oranges, dragon fruit, mango, lime, poppy seeds for 48h before taking the drug, or who are not able to stop strenuous exercise; 15. Those who have special dietary requirements and cannot accept a uniform diet; 16. The woman is pregnant, breastfeeding, or the woman has had unprotected sex within 14 days prior to the test; 17. Women who have used long-acting estrogen and/or progestin injections and/or buried tablets within 6 months prior to screening or who have used oral contraceptives within 30 days prior to screening; 18. Women with a positive blood pregnancy test result for total beta human chorionic gonadotropin (beta-HCG); 19. Persons who develop an acute illness during the pre-study screening phase or prior to study dosing (Remarks: Persons who, in the judgment of the investigator, may interfere with the trial). .; 20. Physical examination, vital signs, laboratory tests (routine blood, urine, blood biochemistry, coagulation function, free thyroid function triple), and 12-lead electrocardiogram with results showing abnormalities of clinical significance; 21. Those who have a positive result for any one or more of the infectious disease screening tests (quantitative hepatitis B surface antigen, hepatitis C antibody, HIV antigen and antibody, and syphilis spirochete antibody); 22. Those with alcohol breath test results >0mg/100mL; 23. A person who has a positive result on any one or more of the substance abuse screenings; 24. Subjects who are judged by other investigators to be unsuitable for participation in this clinical study or who voluntarily withdraw from the study because they cannot complete the study for other reasons.

研究实施时间：

Study execute time：

从 From 2025-06-03 00:00:00至 To 2025-08-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-06-17 00:00:00 至 To 2025-07-24 00:00:00

干预措施：

Interventions：

组别：

RT组（空腹）

样本量：

 13

Group：

RT group (fasting)

Sample size：

干预措施：

先使用参比制剂（R）50mg、再使用受试制剂（T）50mg

干预措施代码：

Intervention：

50mg of the reference formulation (R) followed by 50mg of the test formulation (T)

Intervention code：

组别：

TR组（餐后）

样本量：

 13

Group：

TR group (fed)

Sample size：

干预措施：

先使用受试制剂（T）50mg，再使用参比制剂（R）50mg

干预措施代码：

Intervention：

50 mg of the subject formulation (T) followed by 50 mg of the reference formulation (R)

Intervention code：

组别：

TR组（空腹）

样本量：

 13

Group：

TR group (fasting)

Sample size：

干预措施：

先使用受试制剂（T）50mg，再使用参比制剂（R）50mg

干预措施代码：

Intervention：

50 mg of the subject formulation (T) followed by 50 mg of the reference formulation (R)

Intervention code：

组别：

RT组（餐后）

样本量：

 13

Group：

RT group (fed)

Sample size：

干预措施：

先使用参比制剂（R）50mg、再使用受试制剂（T）50mg

干预措施代码：

Intervention：

50mg of the reference formulation (R) followed by 50mg of the test formulation (T)

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)：

 广州医科大学附属第五医院 

单位级别：

 三级甲等 

Institution
hospital：

The Fifth Affiliated Hospital of Guangzhou Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

不良事件、不良反应、严重不良事件的发生率

指标类型：

次要指标

Outcome：

The incidence of adverse events, adverse reactions, and serious adverse events

Type：

Secondary indicator

测量时间点：

观察所有受试者在临床研究期间发生的任何不良事件。

测量方法：

Measure time point of outcome：

All subjects were observed for any adverse events that occurred during the clinical study.

Measure method：

指标中文名：

米诺环素血药浓度

指标类型：

主要指标

Outcome：

Concentration of minocycline

Type：

Primary indicator

测量时间点：

空腹试验每周期21个采血点采集静脉血，合计42个采血点；餐后试验每周期22个采血点采集静脉血，合计44个采血点。

测量方法：

Measure time point of outcome：

Fasting: 21 timepoints per cycle (42 total); Fed: 22 timepoints per cycle (44 total).

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 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）：

统计单位使用SAS软件（9.4或以上版本）采用区组随机方法产生

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

Statistical units are generated using SAS software (version 9.4 or above) using the block group randomization method

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）：

邮件联系研究者

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

Contact the researcher by email

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(Electronic Data Capture,EDC）

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

Electronic Data Capture,EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-03-04 14:27:12