临床试验/NCT02089451

NCT02089451已完成1 期

A Trial Comparing the Pharmacokinetic Properties of FIAsp After Different Injection Regions and Routes of Administration in Healthy Subjects

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 21 人开始时间: 2014年3月17日最近更新: 2017年2月17日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 21
试验地点: 1
主要终点: Area under the serum insulin aspart concentration-time curve (only for subcutaneous administration)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This trial is conducted in Europe. The aim of the trial is to compare the pharmacokinetic properties (the exposure of the trial drug in the body) of faster-acting insulin aspart (FIAsp) after different injection regions and routes of administration 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: None

入排标准

年龄范围: 18 Years 至 64 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Male or female, aged 18-64 years both inclusive at the time of signing informed consent
•Considered generally healthy upon completion of medical history, physical examination,analysis of laboratory safety variables, vital signs and ECG (electrocardiogram), as judged by the investigator
•Body mass index 20.0-28.0 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 at least one cigarette, cigar or pipe daily)
•Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period

研究组 & 干预措施

FIAsp

Experimental

Each subject will be randomised to a treatment sequence consisting of 5 treatment periods

干预措施: Faster-acting insulin aspart (Drug)

结局指标

主要结局

Area under the serum insulin aspart concentration-time curve (only for subcutaneous administration)

时间窗: From 0 to 12 hours

次要结局

Area under the serum insulin aspart concentration-time curve (only for intramuscular administration)(From 0 to 12 hours)
Maximum observed serum insulin aspart concentration (only for subcutaneous and intramuscular administration)(From 0 to 12 hours)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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