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临床试验 NCT06519604 针对糖尿病目前进行中（不再招募）。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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上海交通大学开放、随机交叉研究评估胰岛素胶囊在中国健康男性中的药代动力学、药效学、生物活性及生物利用度 I期 20
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临床试验NCT06519604旨在研究治疗，主要针对糖尿病。这是一项I期 干预性研究试验，目前试验状态为进行中（不再招募）。试验始于2024年7月17日，计划招募20名患者。该研究由上海交通大学主导，预计于2025年10月30日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年5月16日。
简要概括
Pharmacokinetics and pharmacodynamics study of 3 formulations (human insulin enteric coated capsules 8mg vers. human insulin injection 5IU；human insulin enteric coated capsules 16mg vers. Human Insulin Injection 5IU) Relative biopotency and bioavailability of human insulin enteric coated capsules 8mg/16mg vers. human insulin injection 5IU
详细描述
An open, randomized, single dose, two-way crossover study on Pharmacokinetics, pharmacodynamics, relative biopotency and bioavailability of human insulin enteric coated capsules in healthy Chinese male subjects using hyperinsulinemic euglycemic clamp.
官方标题
An Open, Randomized, Single Dose, Two-way Crossover Study on Pharmacokinetics, Pharmacodynamics, Relative Biopotency and Bioavailability of Human Insulin Enteric Coated Capsules in Healthy Chinese Male Subjects
疾病
糖尿病其他研究标识符
- ORA-H-CN-007
NCT编号
实际开始日期
2024-07-17
最近更新发布
2025-05-16
预计完成日期
2025-10-30
计划入组人数
20
研究类型
干预性研究
试验分期 (阶段)
I期
试验状态
进行中（不再招募）
主要目的
治疗方法
分配方式
随机
干预模型
交叉设计
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Human insulin enteric coated capsules in dose 16mg Single oral administration of human insulin enteric coated capsules in dose 16mg. | Human insulin enteric coated capsules in dose 16mg Single oral administration of human insulin enteric coated capsules in dose 16mg |
实验性Human insulin enteric coated capsules in dose 8mg Single oral administration of human insulin enteric coated capsules in dose 8mg | Human insulin enteric coated capsules in dose 8mg Single oral administration of human insulin enteric coated capsules in dose 16mg |
阳性对照Human Insulin Injection in dose 5IU Single subcutaneous administration of Human Insulin Injection in dose 5IU | Human Insulin Injection in dose 5IU Single subcutaneous administration of Human Insulin Injection in dose 5IU |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
GIRmax | PD endpoint: The maximum glucose infusion rate | 0 -11 hours (hyperinsulinemic euglycemic clamp) |
TGIRmax | PD endpoint: The time to maximum observed glucose infusion rate | 0 -11 hours (hyperinsulinemic euglycemic clamp) |
AUCGIR.0-11h | PD endpoint: The area under the glucose infusion rate curve from 0 to 11 hours | 0 -11 hours (hyperinsulinemic euglycemic clamp) |
AUCGIR0-∞ | PD endpoint: The area under the glucose infusion rate curve from 0 to infinity | 0 -11 hours (hyperinsulinemic euglycemic clamp) |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Cmax | PK endpoint: The maximum observed insulin concentration | 0 -11 hours (hyperinsulinemic euglycemic clamp) |
Tmax | PK endpoint: The time to maximum observed insulin concentration | 0 -11 hours (hyperinsulinemic euglycemic clamp) |
AUCIns0-11h | PK endpoint: The area under the insulin concentration curve from 0 to 11 hours | 0 -11 hours (hyperinsulinemic euglycemic clamp) |
AUCIns0-∞ | PK endpoint: The area under the insulin concentration-time curve from 0 hours to infinity | 0 -11 hours (hyperinsulinemic euglycemic clamp) |
参与助手
资格标准
适龄参与研究
成人
最低年龄要求
20 Years
适龄性别
男性
接受健康志愿者
是
- Healthy Chinese male subjects aged 20-35 (inclusive);
- Body mass index (BMI) between19 and 24 kg/m2 ( extrems inclusive, body mass index= body weight/ height2);
- Normal oral glucose tolerance Test (fasting plasma glucose \[FPG\]< 6.1 mmol/L and 2-hour postprandial blood glucose after loading with glucose \[2hPG\]< 7.8 mmol/L), and HbA1C<6.0%
- Normal insulin releasing test (judged by investigator);
- Considered generally healthy upon completion of medical history, physical examination, vital signs, ECG and analysis of laboratory safety variables, without history of acute and chronic diseases with clinical significance, incl.: of the cardiovascular system, bronchopulmonary, neuroendocrine systems, endocrine system, as well as diseases of the gastrointestinal tract, liver, kidneys, blood, as judged by the Investigator.
- Signed informed consent and volunteers' consent to all restrictions imposed during the study.
- Known allergic or suspected hypersensitivity to investigational product (IP) or related product
- Previous or existing diseases of the cardiovascular system, endocrine system, gastrointestinal system, nervous system, or diseases of the lungs, hematologic, immunology, psychiatry, and metabolic abnormalities, as judged by the investigator;
- History of heavy smoking, alcohol abuse, and drug abuse;
- Taking more than 14 units alcohol per week within 3 months prior to screening (1unit≈360 mL of beer, 45mL of spirits, or 150 mL of wine), or receiving alcohol within 48 hours prior to IP administration, or failure to abstain from alcohol during the trial ;
- Receiving excessive amounts of tea, coffee, and/or caffeine rich beverages (8 or more cups, 1 cup ≈ 250 mL) per day within 3 months prior to screening;
- Use of any medication that may affect glucose lowering effect (such as oral contraceptives, corticosteroids, diuretics, adrenaline, salbutamol, glucagon, growth hormone, thyroid hormone, etc.) within 28 days prior to screening;
- Taking any medications, vitamin product, or any Chinese herbal medicine or nutrition supplements within 2 weeks prior to IP administration;
- Participation in any clinical trial less than 3 months prior to screening or plan to participate in other trials after ICF signed.
- Blood donation or blood loss≥ 200mL of any reasons within 3 months prior to screening; blood transfusion or component blood transfusion within 3 months prior to screening; failure to guarantee not to donate whole blood / component blood (such as plasma, platelets) during the trial or within 30 days after the end of the trial;
- Undergo surgery prior to IP administration within 1 month or plan to undergo surgery during the trial;
- Occurrence of acute disease during screening;
- Positive test of any: HIV-Ab, HBSAg, HCV-Ab,TPAb;
- history of needle phobia and blood phobia;
- Any conditions that make volunteer participation is ineligible judged by investigating physician.
上海交通大学327 个活跃的临床试验可供探索研究责任方
Wang Weiqing, 主要研究者, Professor, PHD, MD, Shanghai Jiao Tong University School of Medicine
没有联系数据。
1 位于 1 个国家/地区的研究中心
Shanghai Municipality
uijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai Municipality, 200025, China