NCT02207348已完成1 期
A Randomised, Open-label, Single-centre, Two-period, Cross-over Trial Investigating Bioequivalence Between Single-dose Liraglutide Administered Subcutaneously With Two Different Pen-injectors
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
- 24
- 试验地点
- 1
- 主要终点
- Area under the liraglutide plasma concentration time curve from 0 to last quantifiable observation (tz) after single dose
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate bioequivalence between single-dose liraglutide administered subcutaneously with two different pen-injectors.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 18-60 years (both inclusive) at the time of signing informed consent
- •Body mass index (BMI) greater than or equal to 27.0 and less than 35.0 kg/m^2
- •Bodyweight up to 130.0 kg (inclusive)
- •HbA1c (glycosylated haemoglobin) below 6.5%
排除标准
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method. Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices), or 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 that might have impact on the trial, as judged by the investigator
- •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 defined as screening
- •Significant history of alcoholism or drug/chemical abuse within 1 year from screening, or a positive result of the urine drug screen or alcohol breath test, or consuming more than 21 units of alcohol per week (one unit of alcohol equals about 250 mL of beer or lager, one glass of wine (120 mL), or 20 mL spirits)
- •Smoking more than 5 cigarettes, or the equivalent, per day and unable to refrain from smoking during the in-house periods
研究组 & 干预措施
Liraglutide 0.6 mg s.c. with FlexPen®
Experimental
干预措施: liraglutide (Drug)
Liraglutide 0.6 mg s.c. with the PDS290 pen-injector
Experimental
干预措施: liraglutide (Drug)
结局指标
主要结局
Area under the liraglutide plasma concentration time curve from 0 to last quantifiable observation (tz) after single dose
时间窗: 0-72 hours following administration of 0.6 mg liraglutide
Maximum observed liraglutide plasma concentration after single dose
时间窗: 0-72 hours following administration of 0.6 mg liraglutide
次要结局
- Number of treatment emergent adverse events (TEAEs)(From baseline to follow-up (up to 3 weeks). Baseline is defined as time of first trial drug administration at Visit 2)
研究者
研究点 (1)
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