临床试验/NCT01620437

NCT01620437已完成1 期

A Randomised, Double-blind, Single-centre, Two-Period Crossover Trial Testing the Bioequivalence of Two Formulations of NN-X14Mix50 in Healthy Japanese Subjects

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2003年11月29日最近更新: 2017年2月24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: 30
试验地点: 1
主要终点: Area under the insulin aspart curve in the interval from 0-16 hours

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 Japan. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 (NN-X14Mix50) in healthy Japanese 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: 20 Years 至 50 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•BMI (body mass index) between 19-29 kg/m^2 (both inclusive)
•Fasting blood glucose between 3.8-6.0 mmol/L (both inclusive)
•Non-smokers

排除标准

•Subjects with a first-degree relative with diabetes mellitus
•Subjects smoke 5 cigarettes or more per day

研究组 & 干预措施

Formulation A

Experimental

干预措施: biphasic insulin aspart 50 (Drug)

Formulation B

Experimental

干预措施: biphasic insulin aspart 50 (Drug)

结局指标

主要结局

Area under the insulin aspart curve in the interval from 0-16 hours

Cmax, maximum insulin aspart concentration

次要结局

tmax, time to maximum insulin aspart concentration
Area under the insulin aspart curve
Mean residence time (MRT)
t½, terminal half-life
Adverse events

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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