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环丝氨酸胶囊在健康受试者中随机、开放、两制剂、单次给药、两周期、交叉空腹和餐后状态下的生物等效性试验
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注册号：

Registration number：

 ChiCTR2500099068 

最近更新日期：

Date of Last Refreshed on：

 2025-03-18 11:10:05 

注册时间：

Date of Registration：

 2025-03-18 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

环丝氨酸胶囊在健康受试者中随机、开放、两制剂、单次给药、两周期、交叉空腹和餐后状态下的生物等效性试验

Public title：

A randomized, open-label, two-formulation, single-dose, two-period, crossover bioequivalence study of cycloserine capsules under fasting and fed conditions in healthy subjects.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

环丝氨酸胶囊在健康受试者中随机、开放、两制剂、单次给药、两周期、交叉空腹和餐后状态下的生物等效性试验

Scientific title：

A randomized, open-label, two-formulation, single-dose, two-period, crossover bioequivalence study of cycloserine capsules under fasting and fed conditions in healthy 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：

彭秀晴 

研究负责人：

胡义亭 

Applicant：

Xiuqing Peng 

Study leader：

Yiting Hu 

申请注册联系人电话：

Applicant telephone：

 +86 137 2279 7058

研究负责人电话：

Study leader's
telephone：

+86 135 8235 7715

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：

 858220780@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 858220780@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：

河北省石家庄市和平西路348号

研究负责人通讯地址：

河北省石家庄市和平西路348号

Applicant address：

No. 348, Heping West Road, Shijiazhuang City, Hebei Province

Study leader's address：

No. 348, Heping West Road, Shijiazhuang City, Hebei 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：

河北省人民医院

Applicant's institution：

Hebei Provincial People's Hospital

研究负责人所在单位：

河北省人民医院

Affiliation of the Leader：

Hebei Provincial People's Hospital

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：

 (2023) 药伦审第(37-01) 号

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：

河北省人民医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Hebei Provincial People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-10-30 00:00:00

伦理委员会联系人：

彭彦辉

Contact Name of the ethic committee：

Yanhui Peng

伦理委员会联系地址：

河北省石家庄市和平西路348号

Contact Address of the ethic committee：

No.348, Heping West Road, Shijiazhuang City, Hebei Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 311 8598 8311

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：

河北省人民医院

Primary sponsor：

Hebei Provincial People's Hospital

研究实施负责（组长）单位地址：

河北省石家庄市和平西路348号

Primary sponsor's address：

No.348, Heping West Road, Shijiazhuang City, Hebei 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)：

河北

市(区县)：

石家庄

Country：

China

Province：

Hebei

City：

Shijiazhuang

单位(医院)：

河北省人民医院

具体地址：

河北省石家庄市和平西路348号

Institution
hospital：

Hebei Provincial People's Hospital

Address：

No.348, Heping West Road, Shijiazhuang City, Hebei Province

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.

研究疾病：

结核病等  

Target disease：

Tuberculosis and other diseases

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： 以河北龙海药业有限公司生产的环丝氨酸胶囊（规格：250mg）为受试制剂，日本明治生产的环丝氨酸胶囊（规格：250mg）为参比制剂。比较中国健康受试者在空腹和餐后两种状态下单次口服环丝氨酸胶囊的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。 次要研究目的： 评价中国健康受试者在空腹和餐后两种状态下单次口服环丝氨酸胶囊受试制剂或参比制剂后的安全性。  

Objectives of Study：

Main study objectives: Cycloserine capsule (specification: 250mg) produced by Hebei Longhai Pharmaceutical Co., Ltd. was used as the test preparation, and cycloserine capsule (specification: 250mg) produced by Meiji in Japan was used as the reference preparation. To evaluate the bioequivalence of cycloserine capsules by comparing the plasma concentration and main pharmacokinetic parameters of cycloserine capsules in Chinese healthy subjects under fasting and postprandial states. Secondary study objectives: To evaluate the safety of single oral administration of the test formulation or reference formulation of cycloserine capsules in Chinese healthy subjects in both fasting and postprandial states.

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) 既往或目前正患有心血管系统、内分泌系统、精神神经系统、消化系统、呼吸系统、血液系统、免疫系统、泌尿生殖系统、眼、耳鼻喉、皮肤、骨骼肌肉慢性疾病或重大疾病者（问诊）； 2) 有精神病家族史者（问诊）； 3) 药物、食物过敏史者或过敏体质者，对环丝氨酸或其辅料（滑石粉）有过敏史者（问诊）； 4) 有吞咽困难或任何影响药物吸收的胃肠道疾病史者（问诊）； 5) 乳糖不耐受（喝牛奶及使用奶制品腹泻）者； 6) 不能耐受静脉穿刺者，有晕针晕血史者或静脉采血困难者； 7) 筛选前6个月内有药物滥用史或使用过任何毒品者； 8) 有任何可能影响试验安全性或药物体内代谢的手术史、外伤史者，或在筛选前6个月内接受过外科手术或计划在试验期间进行手术者，以及凡接受过会影响药物吸收、分布、代谢、排泄的手术者； 9) 筛选前3个月内献血或大量失血（＞=400mL），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3个月内献血或血液成份者； 10) 筛选前3个月内每周饮酒量大于14单位（1单位≈357mL啤酒或43mL酒精量为40%的白酒或147mL酒精量为12%的葡萄酒），或试验期间不能禁酒者； 11) 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； 12) 筛选前3个月内参加过其他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；或非本人来参加临床试验者； 13) 筛选前3个月内每天饮用茶、咖啡和/或含咖啡因的饮料，或试验期间不能停止饮用者； 14) 筛选前1个月内使用过任何抑制或诱导肝脏药物代谢酶的药物（如：诱导剂-巴比妥类、卡马西平、苯妥英、利福平；抑制剂-SSRI类抗抑郁药、西咪替丁、环孢素、地尔硫卓、大环内酯类、吡咯类抗真菌药、HIV蛋白酶抑制剂、镇静催眠药、维拉帕米、氟喹诺酮类、抗组胺类）以及影响药代动力学及受试者安全性的药物（如：异烟肼、乙硫异烟胺）者； 15) 筛选前1个月内接种过疫苗，或者计划在研究期间进行疫苗接种者； 16) 筛选前14天内服用了任何药物（包括中草药）或保健品者； 17) 服药前48h内进食可能影响药物体内代谢的饮食（包括火龙果、芒果、西柚、葡萄柚、杨桃及其制品），或研究者认为有其他影响药物吸收、分布、代谢、排泄的饮食者； 18) 服药前48h内服用过任何含酒精的制品，或酒精呼气检测结果>0mg/100mL者； 19) 实验室检查（血液分析、尿液分析+尿有形成分分析、血生化、凝血四项）、体格检查、12导联心电图、胸部X片，研究者判断结果异常有临床意义者； 20) 人免疫缺陷病毒抗体、乙型肝炎病毒表面抗原、乙型肝炎病毒e抗原或丙型肝炎病毒抗体、梅毒螺旋体抗体检查有一项或一项以上异常有临床意义者； 21) 尿液毒品筛查阳性者； 22) 对饮食有特殊要求，不能遵守统一饮食（标准餐、高脂餐）者； 23) 女性受试者除上述要求外，符合下列条件：(1)筛选前1个月内使用口服避孕药者或筛选前6个月内使用长效雌激素或孕激素注射剂或埋植片者；(2)妊娠或哺乳期女性；(3)血妊娠检查阳性者； 24) 其他研究者判定受试者有任何不适宜参加试验的情况。

Exclusion criteria：

1) Patients with past or current chronic or serious diseases of cardiovascular system, endocrine system, mental nervous system, digestive system, respiratory system, blood system, immune system, genitourinary system, eye, ear, nose and throat, skin, skeletal muscle (inquiry); 2) family history of psychosis (inquiry); 3) patients with a history of drug or food allergy or allergic constitution, and patients with a history of allergy to cycloserine or its excipents (talc) (inquiry); 4) patients with a history of dysphagia or any GI condition affecting drug absorption (inquiry); 5) lactose intolerance (diarrhea caused by consumption of milk and dairy products); 6) those who cannot tolerate venipuncture, have a history of dizzy with needle or blood, or have difficulty in venous blood collection; 7) having a history of drug abuse or using any drug within 6 months before screening; 8) patients with a history of surgery, trauma, or surgery within 6 months before screening or planned to undergo during the trial that may affect the safety or metabolism of the drug, and those who have undergone surgery that may affect the absorption, distribution, metabolism, or excretion of the drug; 9) blood donation, massive blood loss (>=400mL), transfusion or use of blood products within 3 months before screening; Or plan to donate blood or blood components during or within 3 months after the study; 10) subjects who consumed more than 14 units of alcohol per week in the 3 months before screening, or who could not abstain from alcohol during the study; 11) who smoked >5 cigarettes per day in the 3 months before screening or did not stop using any tobacco products during the study; 12) participants who participated in other drug clinical trials or used investigational devices within 3 months before screening and took investigational drugs or used investigational devices; Or those who are not personally enrolled in a clinical trial; 13) drinking tea, coffee and/or caffeinated beverages daily within 3 months before screening or unable to stop drinking during the trial; 14) use of any drugs that inhibit or induce hepatic drug-metabolizing enzymes (e.g., inductors-barbiturates, carbamazepine, phenytoin, rifampicin; Inhibitors-ssri antidepressants, cimetidine, cyclosporine, diltiazem, macrolides, pyrrole antifungals, HIV protease inhibitors, sedative hypnotics, verapamil, fluoroquinolones, antihistamines) and drugs affecting pharmacokinetics and subject safety (such as isoniazid, ethionamide); 15) vaccinated within 1 month before screening or plan to be vaccinated during the study; 16) who had taken any medicine (including Chinese herbal medicine) or health supplement within 14 days before screening; 17) eating within 48 hours before medication (including dragon fruit, mango, grapefruit, grapefruit, star fruit and its products) that may affect the absorption, distribution, metabolism, and excretion of the drug, or eating other foods that the researchers believe may affect the absorption, distribution, metabolism, and excretion of the drug; 18) had taken any alcoholic products within 48 hours before taking the drug, or had a breath alcohol test result >0mg/100mL; 19) laboratory tests (blood analysis, urinalysis + urine component analysis, blood biochemistry, and coagulation), physical examination, 12-lead electrocardiogram, and chest X-ray, if the investigators judged that the abnormal results were clinically significant; 20) clinically significant abnormalities in one or more of human immunodeficiency virus antibody, hepatitis B virus surface antigen, hepatitis B virus e antigen or hepatitis C virus antibody, and treponema pallidum antibody; 21) with positive urine drug screening; 22) those who have special requirements for diet and cannot abide by uniform diet (standard diet, high-fat diet); 23) In addition to the above requirements, the following criteria were met: (1) oral contraceptive use within 1 month before screening or long-acting estrogen or progestin injection or implant use within 6 months before screening; (2) pregnant or lactating women; (3) positive blood pregnancy test; 24) any condition deemed by the other investigator to be inappropriate for trial participation.

研究实施时间：

Study execute time：

从 From 2023-12-11 00:00:00至 To 2024-02-21 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-12-11 00:00:00 至 To 2024-02-21 00:00:00

干预措施：

Interventions：

组别：

T-R空腹组

样本量：

 16

Group：

T-R fast group

Sample size：

干预措施：

第一周期（共4天）16例受试者空腹口服受试制剂1粒，清洗期至少7天后，第二周期（共4天）16例受试者空腹口服参比制剂1粒。

干预措施代码：

Intervention：

In the first cycle (4 days in total), 16 subjects took 1 pill of the test formulation orally in an empty stomach, after a washing period of at least 7 days, and in the second cycle (4 days in total), 16 subjects took 1 pill of the reference formulation orally in an empty stomach.

Intervention code：

组别：

R-T空腹组

样本量：

 16

Group：

R-T fast group

Sample size：

干预措施：

第一周期（共4天）16例受试者空腹口服参比制剂1粒，清洗期至少7天后，第二周期（共4天）16例受试者空腹口服受试制剂1粒。

干预措施代码：

Intervention：

In the first cycle (4 days in total), 16 subjects took 1 capsule of the reference formulation orally on an empty stomach, after a washing period of at least 7 days, and in the second cycle (4 days in total), 16 subjects took 1 capsule of the test formulation orally on an empty stomach.

Intervention code：

组别：

T-R高脂餐后组

样本量：

 16

Group：

T-R fed group

Sample size：

干预措施：

第一周期（共4天）16例受试者高脂餐后30±0.5min口服受试制剂1粒，清洗期至少7天后，第二周期（共4天）16例受试者高脂餐后30±0.5min口服参比制剂1粒。

干预措施代码：

Intervention：

In the first cycle (4 days in total), 16 subjects received 1 pill of the test preparation 30±0.5min after a high-fat meal. After at least 7 days of the washing period, 16 subjects received 1 pill of the reference preparation 30±0.5min after a high-fat meal in the second cycle (4 days in total).

Intervention code：

组别：

R-T高脂餐后组

样本量：

 16

Group：

R-T fed group

Sample size：

干预措施：

第一周期（共4天）16例受试者高脂餐后30±0.5min口服参比制剂1粒，清洗期至少7天后，第二周期（共4天）16例受试者高脂餐后30±0.5min口服受试制剂1粒。

干预措施代码：

Intervention：

In the first cycle (4 days in total), 16 subjects received 1 pill of the reference formulation 30±0.5min after a high-fat meal, after a wash period of at least 7 days, and in the second cycle (4 days in total), 16 subjects received 1 pill of the test formulation 30±0.5min after a high-fat meal.

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)：

 石家庄 

Country：

China

Province：

Hebei

City：

Shijiazhuang

单位(医院)：

 河北省人民医院 

单位级别：

 三甲 

Institution
hospital：

Hebei Provincial People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

环丝氨酸浓度

指标类型：

主要指标

Outcome：

Cycloserine concentration

Type：

Primary indicator

测量时间点：

测量方法：

高效液相色谱-串联质谱（HPLC-MS/MS）法

Measure time point of outcome：

Measure method：

High performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method

指标中文名：

峰浓度

指标类型：

次要指标

Outcome：

Peak concentration

Type：

Secondary indicator

测量时间点：

测量方法：

高效液相色谱-串联质谱（HPLC-MS/MS）法

Measure time point of outcome：

Measure method：

High performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method

指标中文名：

从给药前0h到最后一个可检测的血药浓度的时间内曲线下面积

指标类型：

次要指标

Outcome：

AUC0-t, Area under the curve for the time from 0h before administration to the last detectable blood concentration

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

从给药前0h到外推至无穷远时间的曲线下面积

指标类型：

次要指标

Outcome：

AUC0-∞, Area under the curve from 0h before administration to extrapolation to infinity time

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

达峰浓度的时间

指标类型：

次要指标

Outcome：

Tmax, Time to peak concentration

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

消除速率常数

指标类型：

次要指标

Outcome：

λz, Elimination rate constant

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

消除终末端半衰期

指标类型：

次要指标

Outcome：

t1/2, Terminal terminal half-life was eliminated

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

残留面积百分比

指标类型：

次要指标

Outcome：

AUC_%Extrap, Residual area percentage

Type：

Secondary 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：

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）：

受试者随机：在研究中每名受试者接受受试制剂或参比制剂的顺序将由随机方案确定。随机方案由统计单位应用SAS（9.4或以上版本）按1:1区组随机产生。在筛选时，每名受试者将使用筛选号进行识别，以S+三位阿拉伯数字表示，如S001。试验的第-1天进行随机化，每名合格的受试者将按照筛选号从小到大获得随机号。空腹正式试验随机号以K+三位阿拉伯数字表示，如K001；餐后正式试验随机号以C+三位阿拉伯数字表示，如C001。根据预先制定的随机表随机分配进入T-R或R-T组，并按照相应的给药序列接受相应的研究药物。 因任何原因、不论是否服用了研究药物退出或被撤出临床试验的随机化受试者，将保留其随机编号，该受试者将不被允许再次进入该试验。 药物随机：申办单位提供同一批号试验用药品，对受试制剂和参比制剂分别编号T001、T002、T003…，和R001、R002、R003…。使用SAS（9.4或以上版本），设置种子数，采用完全随机抽样的方法为每个试验周期抽取足够量的药物。研究机构根据随机表上的每个试验周期的试验药物编号抽取药物。随机具有可重现性。试验过程中，因无可预知的意外事故导致药物脱落，将从试验周期随机的备用药物中重新抽取一粒。

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

Subject randomization: The order in which each subject receives the test or reference formulation during the study will be determined by the randomization protocol. The randomization scheme was generated by the statistical unit with the use of SAS (version 9.4 or higher) in blocks of 1:1. At screening, each subject will be identified using a screening number, represented as S+ three digit Arabic numerals, such as S001. Randomization was performed on day -1 of the trial, and each eligible subject will receive a random number in descending order of screening number. The fasting formal trial random number is denoted by K+ three Arabic numerals, such as K001; The formal trial randomization number after meal is indicated by C+ three digit Arabic numerals, such as C001. Patients were randomly assigned to the T-R or R-T group according to a prespecified randomization table and received the study drug in the corresponding dosing sequence. A randomized subject who withdrew or was withdrawn from the trial for any reason, regardless of whether he or she had taken a study drug, retained his or her randomization number, and the subject was not allowed to re-enter the trial. Drug randomization: The sponsor provided the same lot number of investigational drug, and the test and reference formulations were numbered T001, T002, T003, respectively. , and R001, R002, R003... . The seed number was set with the use of SAS (version 9.4 or higher), and an adequate amount of drug was extracted for each trial cycle using completely random sampling. Sites drew drugs according to the trial drug number for each trial cycle on the randomization table. Randomization is reproducible. During the course of the trial, if a drug is dropped due to an unforeseen accident, a new pill will be drawn from the standby drug that was randomly assigned to the trial cycle.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

无

Blinding：

None

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

使用国内公网能查看到的数据存放平台，网址https://www.hbpphosp.cn/newsList.html?cid=21&pid=19

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

Can use the public can see the data storage platform in China, https://www.hbpphosp.cn/newsList.html?cid=21&pid=19

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：

电子病例记录表和EDC

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

eCRF and EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-03-18 11:09:56
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