To compare PK, PD, safety and tolerability of recombinant human insulin aspart (BioGenomics) vs Novorapid® in male healthy volunteers
Phase 1
Completed
- Registration Number
- CTRI/2016/05/006959
- Lead Sponsor
- BioGenomics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 65
Inclusion Criteria
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
Exclusion Criteria
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate equivalence in the PK and PD properties of Recombinant Human Insulin Aspart 100 U/mL as Test product [manufactured by BioGenomics Limited (BGL)] with NovoRapid® 100 U/mL as Reference product [marketed by Novo Nordisk A/S] in healthy, adult, human male subjects under fasting conditions.Timepoint: PK-19 samples <br/ ><br>PD-35 samples
- Secondary Outcome Measures
Name Time Method To assess and compare the safety and tolerability of single-dose administration of both Test and Reference productsTimepoint: Throughout the study