NCT01486901已完成1 期
A Randomised, Single Centre, Double-blind, Two-period Cross-over, Glucose Clamp Trial to Test for Bioequivalence Between Insulatard® (600 Nmol/ml) and Insulatard® (1998 Nmol/ml) 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
- 44
- 主要终点
- Area under the serum insulin concentration-time curve (AUC 0-24 hours)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to test for bioequivalence between two formulations of Insulatard® in healthy subjects.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
- •Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2, inclusive
- •Non-smoker, defined as no nicotine consumption for at least one year
- •Fasting plasma glucose below or equal to 100 mg/dL (5.6 mmol/L)
排除标准
- •Previous participation in this trial or other clinical trials within the last 3 months
- •Body weight above 87.5 kg
- •Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, or sterilisation, or the oral contraceptive pill, which should have been taken without difficulty for at least 3 months, an approved hormonal implant)
- •History of alcohol or drug abuse
研究组 & 干预措施
Formulation A
Experimental
干预措施: isophane human insulin (Drug)
Formulation B
Active Comparator
干预措施: isophane human insulin (Drug)
结局指标
主要结局
Area under the serum insulin concentration-time curve (AUC 0-24 hours)
Maximum serum insulin concentration (Cmax)
次要结局
- Adverse events
- Area under the serum insulin concentration-time curve (AUC 0-inifinity hours)
- Time to maximum serum insulin concentration (tmax)
- Terminal serum insulin half life (t½)
研究者
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