A Trial to Demonstrate Bioequivalence Between Two Insulin Degludec/Liraglutide Formulations, B5 and V2 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Area under the serum IDeg concentration time curve after single dose
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to assess the expected biological equivalence between two formulations of insulin degludec/liraglutide (IDegLira) with identical active ingredient in 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female volunteers
- •Body mass index (BMI) between 18.5 and 27.0 kg/m^2 (both inclusive)
- •Body weight between 60 and 90 kg (both inclusive)
排除标准
- •Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods. Adequate contraceptive measures are implants, injectables, combined oral contraceptives, hormonal intrauterine device, sexual abstinence or vasectomised partner
- •History or presence of cancer, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine (incl. diabetes), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders
- •Use of any prescription or non-prescription medication, except for paracetamol, acetylsalicylic acid, contraceptives and vitamins (but including mega-dose vitamin therapy, as judged by the investigator) within 2 weeks before the trial
- •Drug or alcohol abuse
研究组 & 干预措施
Insulin degludec/liraglutide, B5
Subjects will be randomly allocated to the two single dose administrations (one for each of the two IDegLira formulations) on the two separate dosing visits. The two administration days will be separated by a wash-out period of 7-15 days.
干预措施: insulin degludec/liraglutide (Drug)
Insulin degludec/liraglutide, V2
Subjects will be randomly allocated to the two single dose administrations (one for each of the two IDegLira formulations) on the two separate dosing visits. The two administration days will be separated by a wash-out period of 7-15 days.
干预措施: insulin degludec/liraglutide (Drug)
结局指标
主要结局
Area under the serum IDeg concentration time curve after single dose
时间窗: Assessed from 0 to 120 hours
Area under the plasma liraglutide concentration time curve after single dose
时间窗: Assessed from 0-72 hours
Maximum observed serum IDeg concentration after single dose
时间窗: Assessed from 0-120 hours
Maximum observed plasma liraglutide concentration after single dose
时间窗: Assessed from 0-72 hours
次要结局
- Area under the plasma liraglutide concentration time curve after single dose(Assessed from 0-72 hours)
- Terminal elimination half-life for IDeg after single dose(Assessed from 0-120 hours)
- Area under the serum IDeg concentration time curve after single dose(Assessed from 0-120 hours)
- Time to maximum plasma liraglutide concentration after single dose(Assessed from 0-72 hours)
- Time to maximum IDeg concentration(Assessed from 0-120 hours)
- Terminal elimination half-life of liraglutide after single dose(Assessed from 0-72 hours)