NCT01766245已完成1 期
A Randomised, Single Centre, Double-blind, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Subcutaneous Injections of Semaglutide Produced by Two Manufacturing Processes
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
- 28
- 主要终点
- Area under the plasma semaglutide concentration curve
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) between subcutaneous injections of semaglutide produced by two manufacturing processes.
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 subjects
- •Body mass index (BMI) of 18.5-30 kg/m^2 (both incl.)
排除标准
- •History of or presence of cancer, diabetes, pancreatitis or any clinically relevant cardiovascular diseases or other major disorders
- •Use of prescription or non-prescription medicinal products (except routine vitamins, acetylsalicylic acid and paracetamol) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to the first dosing of semaglutide
- •Smoking, drug or alcohol abuse
- •Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or not using adequate contraceptive methods for the duration of the trial and for 3 months following the last dose of semaglutide
研究组 & 干预措施
Formulation A followed by Formulation B
Experimental
干预措施: semaglutide (Drug)
Formulation B followed by Formulation A
Active Comparator
干预措施: semaglutide (Drug)
结局指标
主要结局
Area under the plasma semaglutide concentration curve
时间窗: 0-4 weeks after a single dose s.c. semaglutide administration
Cmax, the maximum plasma semaglutide concentration
时间窗: 20-40 hours after a single dose s.c. semaglutide administration
次要结局
- The area under the plasma semaglutide concentration curve(From time 0 to infinity after a single dose s.c. semaglutide administration)
- tmax, time to Cmax of semaglutide(20-40 hours)
- t½, terminal elimination half-life of semaglutide(140-200 hours)
- Incidence of adverse events (AEs)(From first dosing to follow-up (5-7 weeks after the second dosing))
- Hypoglycaemic episodes(From first dosing to follow-up (5-7 weeks after the second dosing))
研究者
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