NCT03330314已完成1 期
An Open Label, Fixed-Sequence, Glucose Clamp Study to Compare Molar Potency of HM12460A and Insulin Glargine in Healthy Subjects
Hanmi Pharmaceutical Company Limited2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2017年10月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Blood glucose assessment of HM12460A and insulin glargine over the entire dosing period
研究概览
简要总结
This is a phase 1 study to assess and compare molar potency of HM12460A and glargine in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- 是
入选标准
- •Females must be non-pregnant and non-lactating
- •Males must be surgically sterile or using an acceptable contraceptive method
排除标准
- •History of any major surgery within 6 months prior to screening
- •Use of any new prescription or non-prescription drug in the last 30 days
结局指标
主要结局
Blood glucose assessment of HM12460A and insulin glargine over the entire dosing period
时间窗: 1 month
- Comparison of HM12460A to insulin glargine based on blood glucose profile generated by intravenous infusion
次要结局
- Cmax of HM12460A(1 month)
- AUC of HM12460A(1 month)
研究者
研究点 (2)
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