A Randomized Duble Blinded Two-way Crossover Single-dose Pharmacokinetics and Pharmacodynamics Study of Insulin Lispro (LLC "GEROPHARM", Russia) Versus Humalog® (Eli Lilly) in Healthy Subjects Using the Euglycemic Clamp Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
Pharmacokinetics and pharmacodynamics study Study of 2 formulation of insulin lispro (Insulin Lispro GEROPHARM vers. Humalog® Eli Lilly)
详细描述
A randomized duble blinded two-way crossover single-dose pharmacokinetics and pharmacodynamics study of Insulin Lispro (LLC "GEROPHARM", Russia) versus Humalog® (Eli Lilly) in normal healthy subjects using the euglycemic clamp technique
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study was blinded for Sponsor, investigators and analytical laboratory
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent.
- •Caucasian males having a confirmed healthy diagnosis as per data of standard clinical, laboratory, and instrumental examination methods.
- •Age of 18-50 (both incl.).
- •Body mass index equal to 18.5-27.0 kg/m
- •Volunteers' consent to all restrictions imposed during the study, including adequate methods of contraception.
排除标准
- •Acute inflammatory diseases within 3 weeks before the screening period
- •Episodes of hypoglycemia in the anamnesis, or the presence in the family history of cases of a verified diagnosis of diabetes mellitus in the immediate family
- •Fasting plasma glucose> 6.1 mmol / L
- •Oral glucose tolerance test - blood glucose level ≥ 7.8 mmol / l (2 hours after loading with glucose)
- •Deep vein thrombosis of lower extremities in a history of life or in a family history.
- •Nicotine dependence (use of tobacco less than 6 months before the start of screening)
- •Taking medications, phytopreparations, biologically active supplements less than 14 days before screening
- •Receiving more than 10 units. alcohol per week (1 unit of alcohol is equivalent to 0.5 liters of beer, 200 ml of wine or 50 ml of strong alcohol) or anamnestic information about alcoholism.
- •Donor blood donation in excess of 450 ml, less than 2 months before the study.
- •Participation in a clinical trial of any medications less than 3 months before the start of screening
- •Positive test results for hepatitis C or hepatitis B, HIV, syphilis.
- •Anamnesis information about drug and / or drug dependence and / or substance abuse.
- •Positive test for alcohol content in the exhaled air.
- •A positive test for the content of drugs in the urine.
- •Presence of suspicions of an inflammatory disease of the urinary system as a result of urinalysis.
- •Presence of mental illnesses in the anamnesis.
- •Mental, physical and other reasons that do not allow to adequately assess their behavior and properly fulfill the conditions of the research protocol.
- •Any other conditions that make it difficult, according to the informed opinion of the investigating physician, that volunteer participation in studies
- •Increased sensitivity in the history of heparin, insulin or any of the excipients of the study drugs
- •Weighed allergic anamnesis
- •Abnormalities of the ECG and laboratory parameters from the norms
- •Deviations in basic vital signs: systolic blood pressure is below 100 mm Hg. or above 130 mm Hg, the diastolic blood pressure is below 70 mm Hg. or above 90 mm Hg; heart rate less than 60 or greater than 80
- •Deviations in basic vital signs: systolic blood pressure <100 mmHg. or> 130 mm Hg, diastolic blood pressure <70 mm Hg. Art. or> 90 mm Hg. Art. heart rate <60 or> 80 per minute.
研究组 & 干预措施
Insulin Lispro
Single subcutaneous administration of Insulin Lispro in dose 0.3 IU / kg
干预措施: Insulin Lispro (Drug)
Humalog®
Single subcutaneous administration of Humalog® in dose 0.3 IU / kg
干预措施: Humalog® (Drug)
结局指标
主要结局
Cmax
时间窗: -60, -30 and 0 hours (pre-dose), as well as at, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 210, 240, 270, 300, 360, 420 and 480 minutes post-dose
Pharmacokinetics of insulin lispro by Assessment of Observed Maximum Plasma Concentration (Cmax)
AUC(0-t)
时间窗: -60, -30 and 0 hours (pre-dose), as well as at, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 210, 240, 270, 300, 360, 420 and 480 minutes post-dose
Pharmacokinetics of insulin Lispro by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))
GIRmax
时间窗: 0 hours (pre-dose), as well as at, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 210, 240, 270, 300, 360, 420 and 480 minutes post-dose
Pharmacodynamic of insulin lispro by Maximum Glucose Infusion Rate (GIRmax)
AUCGIR0-t
时间窗: 0 hours (pre-dose), as well as at, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 210, 240, 270, 300, 360, 420 and 480 minutes post-dose
Pharmacodynamic of insulin Lispro by Assessment of GIR Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))
次要结局
未报告次要终点