Bioequivalence Study Comparing the Pharmacokinetics and Glucodynamics of LY2963016 U-200 Formulation With LY2963016 U-100 Formulation in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of LY2963016 U-200 Formulation and LY2963016 U-100 Formulation
研究概览
简要总结
The study will aim to evaluate the following:
- Whether there are any differences in the way the body handles LY2963016 U-200 and LY2963016 U-100.
- How well-tolerated LY2963016 U-200 is compared with LY2963016 U-100.
- How LY2963016 U-200 affects the level of blood sugar in the body compared with LY2963016 U-100.
The study will last up to 17 weeks for each participant, including initial screening and follow up.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a body mass index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m²)
- •Have a fasting plasma glucose less than (<) 6.0 millimoles per liter (mmol/L) (108 milligram per deciliter [mg/dL])
- •Have venous access sufficient to allow for blood sampling and clamp procedures per protocol
排除标准
- •Have known allergies to the study drug, or any components of the formulation
- •Have donated or had a blood loss of 450 milliliter (mL) within 3 months prior to study enrollment
研究组 & 干预措施
LY2963016 U-200 Formulation (Test)
LY2963016 test formulation administered as a subcutaneous (SC) injection in one of two or two of four study periods.
干预措施: LY2963016 (Drug)
LY2963016 U-100 Formulation (Reference)
LY2963016 reference formulation administered as a SC injection in one of two or two of four study periods.
干预措施: LY2963016 (Drug)
结局指标
主要结局
Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of LY2963016 U-200 Formulation and LY2963016 U-100 Formulation
时间窗: One hour before dosing up to 48 hours following administration of study drug
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY2963016 U-200 Formulation and LY2963016 U-100 Formulation
时间窗: One hour before dosing up to 48 hours following administration of study drug
次要结局
- Pharmacodynamics: Total Amount of Glucose Infused (Gtot) of LY2963016 U-200 and LY2963016 U-100(One hour before dosing up to about 30 hours post clamp procedure)
- Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax) of LY2963016 U-200 and LY2963016 U-100(One hour before dosing up to about 30 hours post clamp procedure)