NCT02752087已完成1 期
A Study to Compare the Pharmacokinetics and Pharmacodynamics of LY900014 Test Versus Reference Formulations 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
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours])
研究概览
简要总结
This study of healthy participants evaluated the concentration of a test LY900014 and a reference LY900014 formulation in the bloodstream and how it affected the blood sugar levels. The whole study, including screening, took up to 8 weeks to complete.
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
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female participants who can potentially get pregnant:
- •Must have a negative pregnancy test at the time of screening
- •Agree to continue to use a reliable method of birth control until the end of the study
- •Have a body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m²), inclusive, at screening
- •Are nonsmokers, have not smoked for at least 2 months before entering the study
排除标准
- •Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
- •Have known allergies to insulin lispro, related compounds, or any components of the formulation
- •Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
- •Intend to use over-the-counter or prescription medication within 7 and 14 days, respectively, before dosing (apart from vitamin/mineral supplements, occasional paracetamol, hormonal contraception, or thyroid-replacement therapy)
- •Have used systemic glucocorticoids within 3 months prior to entry into the study
- •Have donated blood of more than 450 milliliters (mL) or more in the last 3 months or provided any blood donation within the last month before screening
研究组 & 干预措施
U-193 LY900014 Test
Experimental
LY900014 test dose administered via subcutaneous (SC) injection
干预措施: LY900014 (Drug)
U-95 LY900014 Reference
Active Comparator
LY900014 reference dose administered via SC injection
干预措施: LY900014 (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours])
时间窗: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, and 480 minutes post study dose for each treatment
PK: Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC\[0-8 Hours\])
次要结局
- Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot)(Blood glucose was measured approximately every 2.5 minutes for the first 30 minutes, then every 5 minutes until 120 minutes post dose, and then every 10 minutes until 480 minutes post dose)
研究者
研究点 (1)
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