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
- 试验地点
- 1
- 主要终点
- To demonstrate equivalence in the PK and PD properties of recombinant Insulin Aspart Mix 30 as test product (manufactured by BioGenomics Ltd) with NovoMix® 30 of Novo Nordisk in healthy, adult, human male subjects
研究概览
简要总结
A Phase I randomized, double-blind, single-center, two treatment, two period, two sequence, crossover, euglycemic clamp study to demonstrate equivalence in the pharmacokinetic and pharmacodynamic properties of BioGenomics Insulin Aspart Mix 30 and Novomix ® 30 and to assess safety and tolerability in healthy, adult, human male subjects under fasting conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
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.
结局指标
主要结局
To demonstrate equivalence in the PK and PD properties of recombinant Insulin Aspart Mix 30 as test product (manufactured by BioGenomics Ltd) with NovoMix® 30 of Novo Nordisk in healthy, adult, human male subjects
时间窗: PK-22, PD-183
次要结局
- To assess and compare the safety and tolerability of single-dose administration of both Test and Reference products.(Throughout the study)
研究者
研究点 (1)
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