Bioequivalence Study Comparing the Pharmacokinetics and Glucodynamics of LY900014 U-200 Formulation With LY900014 U-100 Formulation in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Insulin Lispro Area Under Plasma Concentration Curve Zero to 10 Hours (AUC[0-10])
研究概览
简要总结
The study involves a comparison of a LY900014 U-200 formulation with a LY900014 U-100 formulation. LY900014 is a type of fast acting insulin. Study participants will be administered LY900014 U-100 two times and LY900014 U-200 two times, over 4 study periods, by injection under the skin. Blood samples will be taken to compare how the body handles the study drugs and how they affect the blood sugar levels. Side effects and tolerability will be documented. The study will last about 4 weeks, not including screening and follow up. Screening is required within 28 days prior to the start of the study and follow up is required at least 2 weeks after the last dose of study drug.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or a female (not pregnant and agreeable to take birth control measures until study completion)
- •Have a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m²)
- •Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
- •Have veins suitable for easy blood collection and glucose solution infusion
排除标准
- •Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
- •Have previously participated or withdrawn from this study
- •Had blood loss of more than 450 milliliters (mL) within the last 3 months
- •Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female)
- •Smoke more than 10 cigarettes per day
- •Are infected with hepatitis B or human immunodeficiency virus (HIV)
- •Are taking illegal drugs
研究组 & 干预措施
LY900014-U200
Single subcutaneous (SC) dose of 15 units (U) LY900014 U-200 in two of four study periods
干预措施: LY900014-U200 (Drug)
LY900014-U100
Single SC dose of 15 U LY900014 U-100 in two of four study periods
干预措施: LY900014-U100 (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Insulin Lispro Area Under Plasma Concentration Curve Zero to 10 Hours (AUC[0-10])
时间窗: Predose, 5 minutes (mn), 10mn, 15mn, 20mn, 25mn, 30mn, 35mn, 40mn, 45 mn, 50mn, 55 mn, 60mn, 70mn,90mn,120mn,150mn,180mn, 240mn,300mn,360mn,320mn, 480mn, 540mn, and 600mn (10 hours)
Insulin Lispro AUC From Time Zero to 10 hours post dose (AUC\[0-10h\])
次要结局
- Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm(Predose, every minute from run-in and for the duration of the EC until up to 10 hours postdose)