NCT04022291

Comparison of Pharmacokinetic (PK) and Pharmacodynamic(PD) of Biocon Insulin 70/30 and Humulin® 70/30

A Randomised, Double-blind, Two-period Crossover, Euglycaemic Glucose Clamp Study in Healthy Volunteers to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity of Biocon Insulin 70/30 and Humulin® 70/30

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Biocon Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Two-centre, randomised, double-blind, single dose, two-treatment, two-period, two sequence, crossover, 24-hour euglycaemic glucose clamp trial in healthy subjects.

Detailed description

The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence of Biocon Insulin 70/30 with Humulin® 70/30 in healthy subjects The treatment consists of one single dose of the test or reference product, administered during each of the two study periods, separated by 5-7 days between dosing. The planned trial duration for each subject is about 12 to 36 days. Eligible subjects will undergo two 24-hour euglycaemic clamp examinations, one after administration of the test product and one after administration of the reference product in random order.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
BIOLOGICAL	Humulin ®70/30	Humulin® 70/30 is a premixed suspension of human insulin of recombinant deoxyribonucleic acid (rDNA)origin, which contains 30% short-acting human soluble insulin and 70% intermediate-acting isophane insulin. Human insulin is produced by recombinant deoxyribonucleic acid (rDNA), technology utilizing a non-pathogenic laboratory strain of Escherichia coli.
BIOLOGICAL	Biocon Insulin 70/30	Biocon Insulin 70/30 is a premixed suspension of human insulin of recombinant deoxyribonucleic acid (rDNA)origin, which contains 30% short-acting human soluble insulin and 70% intermediate-acting isophane insulin. Biocon insulin is produced by recombinant deoxyribonucleic acid (rDNA) technology utilizing a non-pathogenic laboratory strain of Escherichia coli.

Timeline

• Start date: 2019-06-15
• Primary completion: 2020-01-20
• Completion: 2020-01-27
• First posted: 2019-07-17
• Last updated: 2020-01-30

Locations

2 sites across 1 country: Germany

Regulatory

• FDA-regulated drug study