A Study Comparing Exposure of Semaglutide and Dapagliflozin Dosed Orally as Mono-components Versus in a Fixed-dose Combination
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- AUC0-24h,sema,ss: area under the semaglutide plasma concentration-time curve during a dosing interval (0 to 24 hours) at steady state
研究概览
简要总结
This study will test how the active substances semaglutide and dapagliflozin act in the body (in terms of their levels in the blood), when they are taken in the form of a combination preparation (a tablet with a fixed dose combination) compared to when oral semaglutide and dapagliflozin are given alone.The study will consist of 2 parts. Part 1 will compare semaglutide to the fixed dose combination tablet (semaglutide/dapagliflozin) and part 2 will compare dapagliflozin to the fixed dose combination tablet (semaglutide/dapagliflozin). Participants will take part in either part 1 or part 2.
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
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •Aged 18-64 years (both inclusive) at the time of signing informed consent.
- •Body mass index between 20.0 and 29.9 kg/m^2 (both inclusive).
- •Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
排除标准
- •Participation (i.e., signed informed consent) in any other interventional, clinical study within 30 days (or 5 half-lifes of the investigational medicinal product, whichever is longer) before randomisation.
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly-effective contraceptive method.
- •Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- •Use of tobacco and nicotine products, defined as any of the below:
- •Smoking more than 5 cigarettes or the equivalent per day
- •Not willing to refrain from smoking and use of nicotine substitute products during the in-house periods
- •Blood donation, plasma donation or blood draw, defined as any of the below:
- •In excess of 400 mL within the past 90 days prior to the day of screening
- •In excess of 50 mL within the past 30 days prior to the day of screening
- •History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant.
- •Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
研究组 & 干预措施
Part 1 sequence A
Semaglutide followed by Semaglutide/dapagliflozin
干预措施: Semaglutide (Drug)
Part 1 sequence B
Semaglutide/dapagliflozin followed by Semaglutide
干预措施: Semaglutide/dapagliflozin (Drug)
Part 2 sequence A
Dapagliflozin followed by Semaglutide/dapagliflozin
干预措施: Dapagliflozin (Drug)
Part 2 sequence B
Semaglutide/dapagliflozin followed by dapagliflozin
干预措施: Semaglutide/dapagliflozin (Drug)
结局指标
主要结局
AUC0-24h,sema,ss: area under the semaglutide plasma concentration-time curve during a dosing interval (0 to 24 hours) at steady state
时间窗: From 0 to 24 hours on day 49 and 84 in Part 1
measured in h\*nmol/L
AUC0-24h,dapa,ss: area under the dapagliflozin plasma concentration-time curve during a dosing interval (0 to 24 hours) at steady state
时间窗: From 0 to 24 hours on day 49 and 98 in Part 2
measured inh\*ng/mL
次要结局
- Cmax,sema,ss: maximum observed semaglutide plasma concentration during a dosing interval (0 to 24 hours) at steady state)(From 0 to 24 hours on day 49 and 84 in Part 1)
- Cmax,dapa,ss: maximum observed dapagliflozin plasma concentration during a dosing interval (0 to 24 hours) at steady state(From 0 to 24 hours on day 49 and 98 in Part 2)
- tmax,dapa,ss: time to maximum observed dapagliflozin plasma concentration during a dosing interval (0 to 24 hours) at steady state(From 0 to 24 hours on day 49 and 98 in Part 2)
- tmax,sema,ss: time to maximum observed semaglutide plasma concentration during a dosing interval (0 to 24) at steady state(From 0 to 24 hours on day 49 and 84 in Part 1)