NCT00813020已完成1 期
A Randomised, Single Centre, Double-blind, Incomplete Block Trial to Test for Equivalence Between Subcutaneous Injections of the GLP-1 Analogue NN9535 in 1 mg/ml, 3 mg/ml and 10 mg/ml Concentrations in Healthy Male Subject
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
- AUC0-8 (NN9535), the area under the plasma NN9535 plasma-concentration-time curve in the interval 0-8 after investigational medicinal product administration
研究概览
简要总结
This trial is conducted in Europe. The aim of this clinical trial is to investigate whether differences exist between three different concentrations of the drug, NN9535, administered in healthy male subjects in equal doses.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Healthy male subjects, based on an assessment of medical history, physical examination and clinical laboratory data at screening, as determined by the Investigator
- •Body weight between 80 kg and 110 kg (both inclusive)
- •Body Mass Index (BMI) between 18 and 27 kg/m2, both inclusive
- •Fasting plasma glucose max 108 mg/dl (6.0 mmol/l)
排除标准
- •Known or suspected allergy to trial product(s) or related products
- •Previous participation in this trial (randomisation)
- •The receipt of any investigational medicinal product within 3 months prior to this trial
- •Subjects who have had a clinically relevant illness within 4 weeks of dosing
- •History of or presence of cancer, diabetes, or any clinically relevant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders
- •Regular smoking as defined by smoking 1 or more cigarettes or the equivalent amount of tobacco pr day, and unable to refrain from smoking during the entire confinement period
研究组 & 干预措施
A
Experimental
干预措施: semaglutide (Drug)
B
Experimental
干预措施: semaglutide (Drug)
C
Experimental
干预措施: semaglutide (Drug)
结局指标
主要结局
AUC0-8 (NN9535), the area under the plasma NN9535 plasma-concentration-time curve in the interval 0-8 after investigational medicinal product administration
时间窗: a 28 day time period
次要结局
- Cmax of the plasma NN9535 curve(a 28 day time period)
研究者
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