NCT00532766已完成不适用
Bioequivalence of Jusline Following Subcutaneous Administration in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline)
研究概览
简要总结
To evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline) after subcutaneous administration, and to compare this profile with Humulin insulin.
详细描述
To study the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline) after subcutaneous administration in the abdominal, and to compare this profile with Humulin insulin for three different preparations (Regular, NPH, and Premixed Regular/NPH (30/70)).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Non-diabetic
- •Age 18-35 year
- •Normal body mass index (BMI 18-25 kg/m2)
排除标准
- •Diabetics
- •Overweight/obese
- •Anemic, with liver, cardiac, renal or thyroid dysfunction
研究组 & 干预措施
2
Experimental
Jusline Humulin
干预措施: Jusline (Drug)
结局指标
主要结局
To evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline)
次要结局
未报告次要终点
研究者
研究点 (1)
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