CTRI/2022/09/045313已完成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
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To demonstrate equivalence in the pharmacokinetic and pharmacodynamic properties of Insulin Glargine 100 U/mL of BioGenomics Limited and Lantus® (Insulin Glargine) 100 U/mL of Sanofi-Aventis in healthy, adult, human male subjects under fasting condition
研究概览
简要总结
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 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
- •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.
结局指标
主要结局
To demonstrate equivalence in the pharmacokinetic and pharmacodynamic properties of Insulin Glargine 100 U/mL of BioGenomics Limited and Lantus® (Insulin Glargine) 100 U/mL of Sanofi-Aventis in healthy, adult, human male subjects under fasting condition
时间窗: PK- 12: One pre- dose sample at 0.0 hrs and 11 post dose samples | PD- 147: 3 pre-dose samples (-0.50, -0.33, -0.17 hrs) and 144 post dose samples (samples every 10 mins throughout the 24 hrs glucose clamp)
次要结局
- To assess and compare the safety and tolerability of subjects after single-dose administration of both Test and Reference products.(Throughout the study)
研究者
研究点 (1)
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