CTRI/2022/09/045313尚未招募1 期
A double-blind, randomized, single-center, two treatment, four period, two sequence, replicate crossover, euglycemic clamp study to demonstrate equivalence in the pharmacokinetic and pharmacodynamic properties of Insulin Glargine 100 IU/mL of BioGenomics Limited and Lantus® (Insulin Glargine 100 IU/mL of Sanofi-Aventis) in healthy, adult, human male subjects under fasting condition
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
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
- •Body Mass Index (18.50-24.90 kg/m2), Glucose Tolerance Test (OGTT), HbA1c <= 5.7, plasma glucose, creatinine clearance >80 mL/min, medical history, clinical examination including vital signs blood pressure, body temperature, radial pulse rate and respiratory rate, physical examination and systemic examination, Chest X-ray PA view
排除标准
- •Hypersensitivity to exogenous insulin or any component of the product or related class of the drugs, . History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, urogenital, dermatological, neurological or psychiatric disease or disorder, History of hyperglycemia, History of hypoglycaemia
研究者
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