NCT01374178已完成1 期
Relative Bioavailability of LY2963016 to LANTUS® After Single Dose Subcutaneous Administration to 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
- 16
- 试验地点
- 1
- 主要终点
- Pharmacokinetics: Area Under the Concentration-Time Curve (AUC)
研究概览
简要总结
The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of LY2963016 compared to those of basal insulin. The study will also gather information on the safety and tolerability of LY2963016 in healthy subjects. The study is approximately 12 weeks.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy males or females
- •Have a body mass index (BMI) between 18.5 and 29.9 kilogram per square meter (kg/m^2)
- •Are nonsmokers
- •Have normal blood pressure and pulse rate
- •Have an electrocardiogram (ECG) considered as within normal limits
- •Have clinical laboratory test results within normal reference range
排除标准
- •Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device
- •Have known allergies to insulin or its excipients
- •Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
- •Show evidence of significant active neuropsychiatric disease
- •Have a history of first-degree relatives known to have diabetes mellitus
- •Have a fasting venous blood glucose >6.0 millimoles per liter (mmol/L)
- •Intend to use over-the-counter or prescription medication
- •Have donated or had a blood loss of 450 milliliters (mL) or more in the past 3 months
- •Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)
研究组 & 干预措施
LY2963016
Experimental
A single 0.5-unit per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously.
干预措施: LY2963016 (Drug)
Lantus
Active Comparator
A single 0.5-U/kg dose of Lantus will be administered subcutaneously.
干预措施: Lantus (Drug)
结局指标
主要结局
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC)
时间窗: Periods 1 and 2: Baseline up to 24 hours
AUC from time zero to 24 hours (AUC0-24) is reported for this outcome measure.
次要结局
- Pharmacokinetics: Maximum Concentration (Cmax)(Periods 1 and 2: Baseline up to 24 hours)
- Time of Maximum Glucose Infusion Rate (tRmax)(Periods 1 and 2: Baseline up to 24 hours)
- Maximum Glucose Infusion Rate (Rmax)(Periods 1 and 2: Baseline up to 24 hours)
- Total Glucose Infused (Gtot)(Periods 1 and 2: Baseline up to 24 hours)
- Number of Participants With Clinically Significant Effects(Baseline up to 30 days)
研究者
研究点 (1)
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