To compare PK, PD, safety and tolerability of recombinant human Insulin Aspart Mix 30(BioGenomics Ltd) vs NovoMix® 30 in male healthy volunteers.

A Randomized, Double Blind, Single Center, Two Treatment, Two-Period, Two Sequence, Crossover, Euglycemic clamp study to demonstrate equivalence in the Pharmacokinetic and Pharmacodynamic properties of Insulin Aspart Mix 30 of BioGenomics Limited and NovoMix® 30 of Novo Nordisk in healthy, adult, human male subjects under fasting condition.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/06/043169

Enrollment

Registered

2022-06-10

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Insulin Aspart Mix 30: BioGenomics insulin aspart mix 30- 100U/ml contains recombinant human soluble insulin aspart/ protamine-crystallized insulin aspart 30/70. Dose 0.3U/kg. Once in 1

Eligibility

Inclusion criteria

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

Exclusion criteria: Hypersensitivity to exogenous insulin,History of hyperglycaemia/hypoglycemia, History of diabetic ketoacidosis, Major illness within past 3 months

Design outcomes

Primary

Measure	Time frame
To demonstrate equivalence in the PK and PD properties of recombinant Insulin Aspart Mix 30 as test product (manufactured by BioGenomics Ltd) with NovoMix® 30 of Novo Nordisk in healthy, adult, human male subjectsTimepoint: PK-22, PD-183	—

Secondary

Measure	Time frame
To assess and compare the safety and tolerability of single-dose administration of both Test and Reference products.Timepoint: Throughout the study	—

Countries

India

Contacts

Public ContactKrishananda Nayak

BioGenomics Ltd

k.nayak@biogenomics.co.in02241617181

Outcome results