To compare PK, PD, safety and tolerability of recombinant human Insulin Aspart Mix 30(BioGenomics Ltd) vs NovoMix® 30 in male healthy volunteers.
Phase 1
Completed
- Registration Number
- CTRI/2022/06/043169
- Lead Sponsor
- BioGenomics Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
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
Exclusion Criteria
Hypersensitivity to exogenous insulin,History of hyperglycaemia/hypoglycemia, History of diabetic ketoacidosis, Major illness within past 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method