CTRI/2016/05/006959已完成1 期
A Phase I double-blind randomized single-dose two period crossover euglycemic clamp study to demonstrate equivalence in the PK and PD properties of BioGenomics Insulin Aspart and NovoRapid and to assess safety and tolerability in healthy male subjects
BioGenomics0 个研究点目标入组 65 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
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%
- •Subjects without any evidence of impaired glucose tolerance in 2 hours Oral Glucose Tolerance Test (OGTT) at screening
- •Absence of disease markers of HIV I & II, a negative P24 antigen test and negative HBsAg and HCVAb
- •Comprehension of the nature and purpose of the study and willingness to comply with the requirements of the entire procedure
- •Negative breath alcohol test at every check-in
排除标准
- •History of hypoglycemia/hyperglycaemia
- •History of diabetic ketoacidosis
- •Any major illness in last three months or any significant ongoing chronic medical illness
- •Recent history of or presence of active kidney or liver dysfunction
- •A history of neuropsychiatric diseases
研究者
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