CTRI/2022/06/043169已完成1 期
A Randomized, Double Blind, Single Center, Two Treatment, Two-Period, TwoSequence, Crossover, Euglycemic clamp study to demonstrate equivalence in thePharmacokinetic and Pharmacodynamic properties of Insulin Aspart Mix 30 ofBioGenomics Limited and NovoMix® 30 of Novo Nordisk in healthy, adult, humanmale subjects under fasting condition.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Hemoglobin: greater than or equal to 12.0 gm%, subject with normal results of 2 hours oral glucose tolerance test (OGTT). Subjects having clinically acceptable 12-lead electrocardiogram. BMI between 18.50 and 24.90 kg/m2
排除标准
- •Hypersensitivity to exogenous insulin,History of hyperglycaemia/hypoglycemia, History of diabetic ketoacidosis, Major illness within past 3 months
研究者
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