CTRI/2022/09/045313
Not yet recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- BioGenomics Ltd
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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