A Randomised, Single Centre, Double-blind, Two-period Crossover, Glucose Clamp Trial to Test for Bioequivalence Between Two Insulin 454 Formulations, With or Without Buffer, and Between Two SIAC Formulations, With or Without Buffer, in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 58
- 主要终点
- Maximum serum insulin degludec concentration (Cmax) (for insulin degludec)
研究概览
简要总结
This trial is conducted i Europe. The aim of this trial is to test for bioequivalence between two explorative formulations of insulin degludec (insulin 454) and between two explorative insulin degludec/insulin aspart (IDegAsp - formerly SIAC) formulations, all with or without buffer, in healthy male subjects. The investigated formulations are explorative, not similar to the proposed commercial formulation.
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
- •Informed consent obtained before any trial-related activities. Trial related activities are any procedure that would not have been performed during the normal management of the subject
- •Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
- •Body mass index (BMI) between 18.0 and 27.0 kg/m^2 (inclusive)
- •Fasting plasma glucose below or equal to 6 mmol/L
- •Sexually active and non-sterilised participants must be informed that they and their partner must use a safe method of contraception during sexual intercourse (risk of pregnancy must be lower than 1%), e.g. implants, injections, combined oral contraceptives or hormonal intrauterinedevice or be willing to refrain from having sexual intercourse from the beginning of the study until up to three months after the conclusion of the study. This serves to exclude the possibilityof a pregnancy through sperm that could have been damaged by the study medication
排除标准
- •A history of any illness that, in the opinion of the investigator, might confound the results of the trial or pose risk in administering the trial product to the subject
- •Known or suspected allergy to trial products or related products
- •Subject who has participated in any other trials involving investigational products within the last 3 months prior to first dosing
研究组 & 干预措施
insulin degludec
干预措施: insulin degludec (Drug)
IDegAsp
干预措施: insulin degludec/insulin aspart (Drug)
结局指标
主要结局
Maximum serum insulin degludec concentration (Cmax) (for insulin degludec)
时间窗: 0-120 hours after dosing
Area under the serum insulin aspart concentration-time curve (for IDegAsp)
时间窗: 0-10 hours after dosing
Maximum serum insulin aspart concentration (Cmax) (for IDegAsp)
时间窗: 0-10 hours after dosing
Area under the serum insulin degludec concentration-time curve (for IDegAsp)
时间窗: 0-120 hours after dosing
Maximum serum insulin degludec concentration (Cmax) (for IDegAsp)
时间窗: 0-120 hours after dosing
Area under the serum insulin degludec concentration-time curve (for insulin degludec)
时间窗: 0-120 hours after dosing
次要结局
未报告次要终点