NCT01133392已完成1 期
Evaluation of the Bioequivalence of Two Formulations of Insulin Lispro in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC0-tlast]
研究概览
简要总结
This study will compare how the body treats 2 different forms of insulin lispro and how they affect blood sugar levels.
详细描述
The 2 formulations of insulin lispro will be referred to here as:
Lispro A
Lispro B
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
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are healthy males or females.
- •Body mass index (BMI) between 18.5 and 29.9 kilograms per meter squared (kg/m^2)
- •Are nonsmokers.
- •Have normal blood pressure and pulse rate, a normal electrocardiogram (ECG), and clinical laboratory test results within normal reference range at screening.
排除标准
- •History of first-degree relatives known to have diabetes mellitus.
- •Evidence of significant active neuropsychiatric disease.
- •Evidence of an acute infection with fever or infectious disease.
- •Intend to use over-the-counter or prescription medication (apart from vitamin/mineral supplements, occasional paracetamol, or birth control methods).
- •Have used systemic glucocorticoids within 3 months prior to entry into the study.
- •Have donated blood of 1 unit or more within the last 3 months prior to study entry.
- •Excessive alcohol intake
- •Have a fasting venous blood glucose (FBG, plasma) >6 millimoles/liter (mmol/L) at screening.
- •Have positive hepatitis B surface antigen.
研究组 & 干预措施
Insulin Lispro A
Experimental
20 units (U) subcutaneously (SC)
干预措施: Insulin lispro A (Drug)
Insulin lispro B
Active Comparator
20 units (U) subcutaneously (SC)
干预措施: Insulin lispro B (Drug)
结局指标
主要结局
Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC0-tlast]
时间窗: 0 up to 8 hours post dose
Primary outcome measure is based on the pharmacokinetic area under the concentration-time curve from time 0 to the last time point with a measurable concentration.
次要结局
- Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)(0 to 8 hours post dose)
- Pharmacokinetic Parameter: Maximum Serum Insulin Concentration [Cmax](0 to 8 hours post dose)
- Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)(0 to 8 hours post dose)
- Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)(0 to 8 hours post dose)
研究者
研究点 (1)
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