EUCTR2015-005287-41-DE进行中(未招募)1 期
A randomized, double-blind trial of single doses of ZP4207 administered s.c. to hypoglycemic Type 1 diabetic patients to describe the pharmacokinetics and pharmacodynamics of ZP4207 as compared to marketed glucagon
Zealand Pharma A/S0 个研究点开始时间: 2015年12月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and female patients with T1D for at least one year, as defined by the American Diabetes Association
- •Having been treated with insulin for T1D for at least 1 year.
- •Age between 18 and 50 years, both inclusive.
- •Body weight between 60 and 90 kg, both inclusive
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 56
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Previously treated with ZP4207.
- •Known or suspected allergy to trial product(s) or related products.
- •Previous participation (randomization) in this trial.
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