NCT02443714已完成4 期
Pharmacokinetic and Pharmacodynamic Profile of Insulin Lispro Using Needle-Free Jet Injection Technology
Chongqing Medical University1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2015年4月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Early insulin exposure
研究概览
简要总结
Needle-free jet injector provides an alternative for patients with diabetes treated by insulin. This study aimed at evaluating pharmacokinetics and pharmacodynamics (PK-PD) profiles of lispro administered by jet injector and conventional pen.
详细描述
This is a randomized, double-blind, double-dummy, crossover study. Eighteen healthy volunteers will be recruited. Lispro (0.2 units/kg) will be administered by jet injector or by conventional pen and a seven-hour euglycemic clamp test will be performed. PK-PD profiles of lispro will be calculated.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The range of height should be 170±10cm.
- •The range of weight should be ±10%kg.
- •Liver and renal function should be normal.
- •Health subjects with no chronic diseases or medications.
排除标准
- •Drug allergy, history of allergic disorders or allergies.
- •A history of liver or kidney disease.
- •Smoker, drinkers.
- •Subjects who participated in other drug trials within a month.
- •Subjects who used medication which is known to organ damage.
结局指标
主要结局
Early insulin exposure
时间窗: The area under the curve (AUC) of insulin from 0 to 30min (AUCins, 0-30min)
次要结局
- Pharmacokinetics(50% insulin absorption time (Ins-TAUC50%))
- Pharmacodynamics(Maximum GIR (GIRmax))
研究者
Qifu Li
Professor
Chongqing Medical University
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Application of Needle-free Injection of Insulin in Patients With Gestational Diabetes MellitusInjectionBlood Glucose, HighGlycemic ControlGestational DiabetesNCT05394727Nanfang Hospital, Southern Medical University20
已完成
不适用
Pharmacology of Insulin Injected With Jet-InjectionDiabetes Mellitus, Type 1NCT00983775Radboud University Medical Center48
撤回
1 期
A Study of a New Type of Insulin in Participants With Type 2 Diabetes on Insulin Injection TherapyDiabetes Mellitus, Type 2NCT02623465Eli Lilly and Company
已完成
1 期
A Study of LY900014 in Participants With Type 2 Diabetes on Insulin Injection TherapyDiabetes Mellitus, Type 2NCT02703337Eli Lilly and Company30
已完成
4 期
Reliability of Insulin by Jet InjectionDiabetes MellitusNCT02272296Radboud University Medical Center30