NCT02111083已完成1 期
Evaluation of the Bioequivalence of Two Formulations of Insulin Lispro in Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Pharmacokinetic Parameter: Area Under the Curve(AUC)
研究概览
简要总结
The study involves 4 injections of insulin lispro and its purpose is to:
- Determine if 2 formulations of insulin lispro are treated by the body in a similar way.
- Compare how the 2 formulations of insulin lispro affect blood sugar level.
- Determine the safety of each insulin lispro formulations and any side effects that might be associated with them when given to healthy participants. The study is expected to last up to approximately 9 weeks for each participant.
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
- 18 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 kilogram 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 (fasting blood glucose [FBG], plasma) >6 millimoles per liter (mmol/L) at screening
- •Have positive hepatitis B surface antigen.
结局指标
主要结局
Pharmacokinetic Parameter: Area Under the Curve(AUC)
时间窗: Zero to infinity [AUC(0-∞)]
Pharmacokinetic Parameter: Maximum Serum Insulin Concentration (Cmax)
时间窗: Day 1, predose through 8 hours post dose in each period
Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Zero to Time of Return to Baseline (AUC0-tlast)
时间窗: Day 1, predose through 8 hours post dose in each period.
次要结局
- Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)(Day1, predose through 8 hours post dose in each period.)
- Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)(Day 1, predose through 8 hours post dose in each period.)
- Pharmacokinetic Parameter: Time of Maximum Observed Serum Concentration (Tmax)(Day 1, predose through 8 hours post dose in each period.)
- Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)(Day 1, predose through 8 hours post dose in each period.)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Bioequivalence of Two Lispro FormulationsHealthy VolunteersNCT01133392Eli Lilly and Company41
撤回
1 期
Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Listro Mix 50/50® and Humalog Mix50/50® in Healthy SubjectsBioequivalence in Healthy SubjectsNCT01400789Wockhardt
撤回
1 期
Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Lispro (Listro™) With Humalog® in Healthy SubjectsBioequivalence in Healthy SubjectsNCT01399255Wockhardt
已完成
1 期
A Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro in Patients With Type 1 DiabetesType 1 DiabetesNCT03903016Sanofi90
已完成
1 期
Study to Compare 2 Formulations of LY900014 in Healthy ParticipantsHealthyNCT03616977Eli Lilly and Company69