NCT01193387已完成1 期
A Trial to Test for Bioequivalence Between Identical NN1250 Formulations, IM1 and IM2, 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
- 26
- 主要终点
- Area under the Insulin Degludec concentration-time curve
研究概览
简要总结
This trial is conducted in Europe. The aim of this clinical trial is to investigate if two identical formulations of NN1250 (insulin degludec, IDeg) have the same level of drug exposure to the body.
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
- 是
入选标准
- •Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the Investigator
- •Body mass index 18.0-27.0 kg/m^2 (both inclusive)
排除标准
- •Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- •Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
- •Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
- •Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures include sterilisation, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomised partner)
研究组 & 干预措施
IDeg (M) IM1
Experimental
干预措施: insulin degludec (Drug)
IDeg (M) IM2
Experimental
干预措施: insulin degludec (Drug)
结局指标
主要结局
Area under the Insulin Degludec concentration-time curve
时间窗: From 0 to 120 hours after single-dose
Maximum observed Insulin Degludec concentration
时间窗: From 0 to 120 hours after single-dose
次要结局
- Area under the Insulin Degludec concentration-time curve(From 0 to infinity after single-dose)
研究者
相似试验
已完成
1 期
A Trial to Demonstrate Bioequivalence Between Two Insulin Degludec/Liraglutide Formulations, B5 and V2 in Healthy SubjectsHealthyDiabetesDiabetes Mellitus, Type 2NCT01916174Novo Nordisk A/S50
已完成
1 期
Bioequivalence Between Two Explorative Insulin Degludec Formulations and Between Two Explorative IDegAsp Formulations in Healthy SubjectsHealthyDiabetesNCT01868581Novo Nordisk A/S58
已完成
1 期
A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT01455142Novo Nordisk A/S32
已完成
1 期
Bioequivalence of Two Insulatard® Formulations in Healthy SubjectsHealthyDiabetesNCT01486901Novo Nordisk A/S44
已完成
1 期
Bioequivalence of Two Mixtard® 30 Formulations in Healthy SubjectsHealthyDiabetesNCT01486888Novo Nordisk A/S45