An Single-dose, Open Label, Randomized Cross-over Study to Explore the Pharmacokinetics and Pharmacodynamics of Epinephrine in Healthy Male and Female Subjects With Different Skin to Muscle Depth (STMD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
A single dose, open label, randomized cross-over study to explore the pharmacokinetics and pharmacodynamics of epinephrine in healthy male and female subjects
详细描述
A single dose, open label, randomized cross-over study to explore the pharmacokinetics and pharmacodynamics of epinephrine in healthy male and female subjects with different skin-to-muscle depth (STMD) of the thigh after injections with four different marketed auto-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 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects, between 18 and 54 years of age (inclusive).
- •Subjects who are able and willing to give written informed consent.
- •Body mass index (BMI) between 28.0 and 40.0 kg/m² (inclusive). Weight on Day -1 may not have changed by more than 3 kg compared to screening.
- •Compressed STMD of 10 mm and above (Part 1+2).
- •Non-smoker for at least 6 months.
排除标准
- •Receipt of medication (prescription or non-prescription) within 14 days prior to the planned drug administration, except for occasional use of paracetamol or ibuprofen.
- •Receipt of any of the following medications within the previous 6 months; beta adrenergic blockers, tricyclic antidepressants, monoamine oxidase inhibitors and catechol-O-methyl transferase inhibitors, methylphenidate, amphetamines, any drugs that may sensitize the heart to arrhythmias, including digitalis and quinidine.
- •History or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neuropsychological, endocrine, gastrointestinal or pulmonary diseases especially asthma bronchiale. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which could affect the endpoint analysis if the disease/condition exacerbated during the study.
- •History or presence of silent infections, including positive tests for HIV1, HIV2, Hepatitis B or C.
- •Presence of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- •Hypersensitivity to epinephrine or any of the excipients (e.g. metabisulphite).
研究组 & 干预措施
Part 1 Group 1
A single dose of 500 μg epinephrine (0.5 mL Suprarenin®) will be administered i.m. and s.c. by using a needle and a syringe in randomized order.
干预措施: Part 1 (Device)
Part 2 group 1
300 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)
干预措施: Part 2 Group 1 (Device)
Part 2 Group 2
500 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)
干预措施: Part 2 group 2 (Drug)
Part 2 Group 3
300 μg epinephrine auto-injector (Fastjekt, MEDA Pharma, 16 mm needle length)
干预措施: Part 2 group 3 (Device)
Part 2 Group 4
300 μg epinephrine auto-injector (Jext, Alk-Abelló, 15 mm needle length)
干预措施: Part 2 Group 4 (Device)
结局指标
主要结局
Cmax
时间窗: 14 days
Maximum observed drug concentration
tmax
时间窗: 14 days
Time of the maximum drug concentration (obtained without interpolation). If the maximum value occurs at more than one time point, tmax is defined as the first time point with this value.
次要结局
未报告次要终点