NCT00966368已完成1 期
A Trial to Test for Bioequivalence Between Two NN1250 Formulations 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
- 27
- 试验地点
- 1
- 主要终点
- Maximum observed Insulin Degludec concentration after single dose
研究概览
简要总结
This trial was conducted in North America. The aim of this clinical trial was to investigate if two formulations of NN1250 (insulin degludec) 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 ECG (electrocardiogram), 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
研究组 & 干预措施
IDeg E
Experimental
干预措施: insulin degludec (Drug)
IDeg M
Experimental
干预措施: insulin degludec (Drug)
结局指标
主要结局
Maximum observed Insulin Degludec concentration after single dose
时间窗: From 0 to 120 hours after dosing
Area under the Insulin Degludec concentration-time curve from 0 to 120 hours after single dose
时间窗: From 0 to 120 hours after dosing
次要结局
- Time to maximum observed Insulin Degludec concentration after single dose(From 0 to 120 hours after dosing)
- Area under the Insulin Degludec concentration-time curve from 0 to 24 hours after single dose(From 0-24 hours after dosing)
- Terminal half-life for Insulin Degludec(From 0 to 120 hours after dosing)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Comparison Between Two Formulations of NN5401 in Healthy SubjectsHealthyDiabetesNCT01125553Novo Nordisk A/S26
已完成
1 期
A Trial to Investigate the Bioequivalence of Norditropin® (Somatropin) Versus Genotropin® (Somatropin) in Healthy Adult SubjectsGrowth DisorderHealthyNCT01943084Novo Nordisk A/S32
已完成
1 期
Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult VolunteersGenetic DisorderPrader-Willi SyndromeGrowth DisorderHealthyIdiopathic Short StatureNCT01401244Novo Nordisk A/S30
撤回
1 期
Bioequivalence of Two Products (Norditropin® Versus Nutropin AQ®) in Healthy Adult VolunteersGrowth DisorderHealthyNCT01512095Novo Nordisk A/S
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