NCT01527630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
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
- 30
- 试验地点
- 1
- 主要终点
- Area under the insulin aspart concentration-time curve in the interval from 0 to 16 hours
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
- •Considered generally healthy upon completion of medical history and physical examination, as judged by the Investigator or Sub-Investigator.
- •Body Mass Index (BMI) between 19-29 kg/m^2 (inclusive)
- •Fasting plasma glucose between 3.8-6.0 mmol/L (both inclusive)
排除标准
- •Clinically significant abnormal haematology, biochemistry or urinalysis screening tests, as judged by the Investigator or Sub-Investigator
- •Any serious systemic infectious disease that had occurred during the 4 weeks prior to the screening, as judged by the Investigator or Sub-Investigator
- •Any inter-current illness that might affect blood glucose, as judged by the Investigator or Sub-Investigator
- •Hepatitis B or C, or HIV (human immunodeficiency virus) positive
- •Subjects with a first degree relative with diabetes mellitus
- •History of or presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematologic, neurologic, or psychiatric diseases or disorder
- •Subjects who consumed more than 28 units of alcohol per week or who had a significant history of alcoholism or drug/chemical abuse
- •Subjects who smoked more than 5 cigarettes per day
- •Subjects who had taken part in strenuous exercise within 7 days prior to the screening
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 concentration-time curve in the interval from 0 to 16 hours
Cmax, maximum insulin aspart concentration
次要结局
- Area under the insulin aspart concentration-time curve
- MRT, mean residence time
- Tmax, time to maximum insulin aspart concentration
- t½, terminal half-life
研究者
研究点 (1)
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