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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- TGIRmax
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This study was open for subjects, sponsor and investigators except for analytical laboratory.
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Human insulin enteric coated capsules in dose 16mg
Single oral administration of human insulin enteric coated capsules in dose 16mg.
干预措施: Human insulin enteric coated capsules in dose 16mg (Drug)
Human insulin enteric coated capsules in dose 8mg
Single oral administration of human insulin enteric coated capsules in dose 8mg
干预措施: Human insulin enteric coated capsules in dose 8mg (Drug)
Human Insulin Injection in dose 5IU
Single subcutaneous administration of Human Insulin Injection in dose 5IU
干预措施: Human Insulin Injection in dose 5IU (Drug)
结局指标
主要结局
TGIRmax
时间窗: 0 -11 hours (hyperinsulinemic euglycemic clamp)
PD endpoint: The time to maximum observed glucose infusion rate
AUCGIR.0-11h
时间窗: 0 -11 hours (hyperinsulinemic euglycemic clamp)
PD endpoint: The area under the glucose infusion rate curve from 0 to 11 hours
AUCGIR0-∞
时间窗: 0 -11 hours (hyperinsulinemic euglycemic clamp)
PD endpoint: The area under the glucose infusion rate curve from 0 to infinity
GIRmax
时间窗: 0 -11 hours (hyperinsulinemic euglycemic clamp)
PD endpoint: The maximum glucose infusion rate
次要结局
- AUCIns0-11h(0 -11 hours (hyperinsulinemic euglycemic clamp))
- AUCIns0-∞(0 -11 hours (hyperinsulinemic euglycemic clamp))
- Cmax(0 -11 hours (hyperinsulinemic euglycemic clamp))
- Tmax(0 -11 hours (hyperinsulinemic euglycemic clamp))
研究者
Wang Weiqing
Professor, PHD, MD
Shanghai Jiao Tong University School of Medicine