A Single Centre, Randomised, Double-blind, Three-period Cross-over Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects
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 plasma liraglutide concentration time curve
研究概览
简要总结
The main purpose of the trial is to compare the bioavailability (extent of drug absorption into the circulation) of insulin degludec and liraglutide as part of a combination product insulin degludec/liraglutide compared to the corresponding doses of single, separate injections of insulin degludec and liraglutide. Participants will receive all three test substances. The order of trial administration will be allocated by chance. During the trial period, serials of blood samples will be collected from the participants at three dosing periods, in order to determine the concentration of insulin degludec and liraglutide. The total volume of blood taken throughout the whole trial period will be less than 400 mL. Participants will be asked to stay on daytime and overnight in the trial sites on some predefined days. For other outpatient days, participants need to attend the trial site as required for drug administration or required assessments.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
IDeglira-IDeg-Liraglutide
Treatment sequence first Insulin Degludec/Liraglutide, then Insulin Degludec, then Liraglutide
干预措施: insulin degludec/liraglutide (Drug)
IDeglira-IDeg-Liraglutide
Treatment sequence first Insulin Degludec/Liraglutide, then Insulin Degludec, then Liraglutide
干预措施: insulin degludec (Drug)
IDeglira-IDeg-Liraglutide
Treatment sequence first Insulin Degludec/Liraglutide, then Insulin Degludec, then Liraglutide
干预措施: liraglutide (Drug)
IDeglira-Liraglutide-IDeg
Treatment sequence first Insulin Degludec/Liraglutide, then Liraglutide, then Insulin Degludec
干预措施: insulin degludec/liraglutide (Drug)
IDeglira-Liraglutide-IDeg
Treatment sequence first Insulin Degludec/Liraglutide, then Liraglutide, then Insulin Degludec
干预措施: insulin degludec (Drug)
IDeglira-Liraglutide-IDeg
Treatment sequence first Insulin Degludec/Liraglutide, then Liraglutide, then Insulin Degludec
干预措施: liraglutide (Drug)
IDeg-Liraglutide-IDeglira
Treatment sequence first Isulin Degludec, then Liraglutide, then Insulin Degludec/Liraglutide
干预措施: insulin degludec/liraglutide (Drug)
IDeg-Liraglutide-IDeglira
Treatment sequence first Isulin Degludec, then Liraglutide, then Insulin Degludec/Liraglutide
干预措施: insulin degludec (Drug)
IDeg-Liraglutide-IDeglira
Treatment sequence first Isulin Degludec, then Liraglutide, then Insulin Degludec/Liraglutide
干预措施: liraglutide (Drug)
IDeg-IDeglira-Liraglutide
Treatment sequence first Insulin Degludec, then Insulin Degludec/Liraglutide, then Liraglutide
干预措施: insulin degludec/liraglutide (Drug)
IDeg-IDeglira-Liraglutide
Treatment sequence first Insulin Degludec, then Insulin Degludec/Liraglutide, then Liraglutide
干预措施: insulin degludec (Drug)
IDeg-IDeglira-Liraglutide
Treatment sequence first Insulin Degludec, then Insulin Degludec/Liraglutide, then Liraglutide
干预措施: liraglutide (Drug)
Liraglutide-IDeg-IDeglira
Treatment sequence first Liraglutide, then Insulin Degludec, then Insulin Degludec/Liraglutide
干预措施: insulin degludec/liraglutide (Drug)
Liraglutide-IDeg-IDeglira
Treatment sequence first Liraglutide, then Insulin Degludec, then Insulin Degludec/Liraglutide
干预措施: insulin degludec (Drug)
Liraglutide-IDeg-IDeglira
Treatment sequence first Liraglutide, then Insulin Degludec, then Insulin Degludec/Liraglutide
干预措施: liraglutide (Drug)
Liraglutide-IDeglira-IDeg
Treatment sequence first Liraglutide, then Insulin Degludec/Liraglutide, then Insulin Degludec
干预措施: insulin degludec/liraglutide (Drug)
Liraglutide-IDeglira-IDeg
Treatment sequence first Liraglutide, then Insulin Degludec/Liraglutide, then Insulin Degludec
干预措施: insulin degludec (Drug)
Liraglutide-IDeglira-IDeg
Treatment sequence first Liraglutide, then Insulin Degludec/Liraglutide, then Insulin Degludec
干预措施: liraglutide (Drug)
结局指标
主要结局
Area under the plasma liraglutide concentration time curve
时间窗: from 0 to last quantifiable observation after single dose of insulin degludec/liraglutide and liraglutide, assessments from 0 hours to 72 hours
Calculated based on liraglutide concentration in plasma
Area under the serum insulin degludec concentration time curve
时间窗: From 0 to last quantifiable observation after single dose of insulin degludec/liraglutide and insulin degludec, assessments from 0 hours to 120 hours
Calculated based on insulin degludec concentration in serum
次要结局
- Area under the plasma liraglutide concentration time curve from 0 to infinity after single dose(0 hours to 72 hours)
- Maximum observed plasma liraglutide concentration(0 hours to 72 hours)
- Time to maximum plasma liraglutide concentration(0 hours to 72 hours)
- Area under the serum insulin degludec concentration time curve from 0 to infinity after single dose(0 hours to 120 hours)
- Maximum observed serum insulin degludec concentration(0 hours to 120 hours)
- Time to maximum serum insulin degludec concentration(0 hours to 120 hours)
- Terminal elimination half-life for insulin degludec(0 hours to 120 hours)
- Terminal elimination half-life of liraglutide(0 hours to 72 hours)
- Number of treatment emergent adverse events(Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit))
- Number of treatment emergent hypoglycaemic episodes(Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit))
- Local tolerability at the injection site(Visit 2 (Day 1, randomisation), Visit 5 (7-14 days after last dosing visit))