Evaluation of the Pharmacokinetics and Pharmacodynamics of Spray-Dried Recombinant Human Insulin Powder for Inhalation Administered Via a Dry Powder Inhalation Device Relative to SC Recombinant Human Insulin in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- early T50%
研究概览
简要总结
Evaluation of the pharmacokinetics and pharmacodynamics of different doses of spray-dried recombinant human insulin powder for inhalation administered via a dry powder uinhalation device compared with subcutaneously administered regular human insulin in healthy male volunteers under the conditions of a eugycemic clamp.
详细描述
Explorative, single-center, randomized, open label, 4-way crossover study to evaluate the pharmacokinetics and pharmacodynamics of different doses of spray-dried recombinant human insulin powder for inhalation administered via a dry powder uinhalation device compared with subcutaneously administered regular human insulin in healthy male volunteers under the conditions of a eugycemic clamp.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •non smoking for at least 12 months
- •BMI equal to or less than 28
- •no clinically significant abnormalities
- •FVC and FEV1 equal to or more than 80%
- •willing to participate and to sign informed consent form
排除标准
- •positive results for insulin antibodies at screening
- •history of substance abuse or dependency within last 5 years
- •positive screening test for substance abuse
- •positive blood test for HIV, hepatitis B or hepatitis C antibody
- •fasting blood glucose of more than 126mg/dl
- •any existing medical conditions which might interfere with absoprtion, distribution, metabolism or excretion of study medication
- •history of bronchospastic disease(asthma), tachycardia, migraine headache, hypoglycemic episodes, jaundice, liver diseases, arterial hemorrhaging, severe hypertension or hypotension, cardiac abnormality, renal disease, allergies, unresolved psychiatric illness, drug-induced myopathy or any other clinically significant abnormality
- •has received investigational medications within 21 days prior to receiving the first dose of study medication
- •has taken or used any prescription medications within 21 days prior to receiving the first dose of study medication
- •has taken or used any OTC medications,vitamins or herbal and/or nutritional supplements within 10 days days prior to receiving the first dose of study medication
- •health that may be adversely affected by procedures or medications used in the study
- •unwillingness or inability to understand or to follow required study restrictions and procedures
结局指标
主要结局
early T50%
maximum insulin serum concentration
late T50%
Tmax
AUC
次要结局
- AUC
- early T50%
- late T50%
- Tmax
- maximum glucose infusion rate