NCT01620333已完成1 期
A Randomised, Open-labelled, Single-centre, Two-period Crossover Trial Characterizing the Pharmacokinetics and Pharmacodynamics of NN-X14Mix50 and NN-X14Mix70 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
- 24
- 试验地点
- 1
- 主要终点
- Area under the insulin aspart curve in the interval from 0 to 24 hours (BIAsp 70)
研究概览
简要总结
This trial is conducted in Japan. The aim of this trial is to investigate the pharmacokinetics of biphasic insulin aspart 50 (NN-X14Mix50) and biphasic insulin aspart 70 (NN-X14Mix70) in Japanese healthy volunteers.
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
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) of 19-27 kg/m^2 (both inclusive)
- •Fasting blood glucose between 3.8-6 mmol/L (68.4-108.0 mg/dL) (both inclusive
- •Considered generally healthy upon completion of medical history and physical examination, as judged by the Investigator or Sub-Investigator
排除标准
- •Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator or Sub-Investigator(s)
- •Any serious systemic infectious disease that occurred during the 4 weeks prior to the screening, as judged by the Investigator or Sub-Investigator
- •Any inter-current illness that may affect blood glucose, as judged by the Investigator or Sub-Investigator
- •Hepatitis B or C, or HIV (human immunodeficiency virus)
- •Use of prescription drugs within 2 weeks preceding the screening
- •Use of non-prescription drugs, except routine vitamins or drugs that may not
- •Blood donation of more than 1150 mL within the last 12 months
- •Subjects with a first degree relative with diabetes mellitus
- •History of or presence of diabetes
- •History of or presence of cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematologic, neurologic, or psychiatric diseases or disorder
- •Previous history of serious allergy or anaphylactic reaction
- •Subjects who consume more than 28 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse
- •Subjects who smoke more than 5 cigarettes per day
研究组 & 干预措施
Treatment period 2
Experimental
干预措施: biphasic insulin aspart 70 (Drug)
Treatment period 1
Experimental
干预措施: biphasic insulin aspart 50 (Drug)
Treatment period 1
Experimental
干预措施: biphasic insulin aspart 70 (Drug)
Treatment period 2
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 to 24 hours (BIAsp 70)
次要结局
- Adverse events
- Cmax, maximum insulin aspart concentration
- t½, terminal elimination half life
- tmax, time to maximum insulin aspart concentration
- Mean residence time (MRT)
- Area under the curve from time 0 to infinity (0-∞)
- Area under the insulin aspart curve in the interval from 0 to 24 hours (BIAsp 50)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Pharmacokinetics of Insulin Detemir in Subjects With Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT01542450Novo Nordisk A/S23
已完成
1 期
Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and 50 in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT01620424Novo Nordisk A/S10
已完成
1 期
A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543Congenital Bleeding DisorderHaemophilia ANCT01238367Novo Nordisk A/S6
已完成
3 期
Comparison of Biphasic Insulin Aspart Produced by the NN2000 Process to Current Process to in Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT00564668Novo Nordisk A/S126
已完成
4 期
Safety and Efficacy of Insulin Aspart in Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT01649570Novo Nordisk A/S123