NCT01527656已完成1 期
Single-Centre, Randomised, Balanced, Double-Blind, Cross-Over Trial Investigating the Bioequivalence of Formulation 2 and Formulation 4 of Biphasic Insulin Aspart 70 in Healthy Male 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
- 40
- 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
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 70 in healthy male 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
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Considered generally healthy upon completion of medical history and physical examination, as judged by the investigator
- •Body Mass Index (BMI) between 19.0-30.0 kg/m^2
- •Glycohemoglobin (HbA1c) within laboratory normal range
- •Non-smokers
排除标准
- •Clinically significant abnormal haematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator
- •Liver enzyme values (ALAT and ASAT) exceeding 2 times the upper reference limit according to the local laboratory
- •A history of any illness that, in the opinion of the Investigator and/or Sponsor, might confound the results of the trial or pose additional risk in administering the investigational product to the subject
- •History of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive urine drug screen and breath alcohol screen)
- •HIV (human immunodeficiency virus), Hepatitis B or C positive
- •Subjects with a first-degree relative with diabetes mellitus
- •A history of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reactions
- •Known or suspected allergy to trial product or related products
- •Smoking during the past three months
研究组 & 干预措施
Formulation A
Experimental
干预措施: biphasic insulin aspart 70 (Drug)
Formulation B
Experimental
干预措施: biphasic insulin aspart 70 (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
- Mean residence time (MRT)
- Area under the insulin aspart curve
- t½, terminal half-life
- tmax, time to maximum insulin aspart concentration
- Incidence of hypoglycaemic events
研究者
研究点 (1)
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