05Jan 2022
Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar Insulin‐R with the US‐licensed Humulin® R formulation in healthy subjects: Results from the RHINE‐1 (Recombinant Human INsulin Equivalence‐1) study

Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar Insulin‐R with the US‐licensed Humulin® R formulation in healthy subjects: Results from the RHINE‐1 (Recombinant Human INsulin Equivalence‐1) study

The aim of RHINE‐1, a double‐blind, randomized, two‐treatment, two‐period, two‐sequence crossover study, was to establish the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of proposed biosimilar Insulin‐R (Biocon's Insulin‐R) and Humulin® R (Eli Lilly and Company, USA). Short‐acting human insulin (Human Insulin‐R) is prandial insulin indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. In this automated euglycemic glucose clamp study, 42 healthy subjects were randomized (1:1) to receive a single dose of 0.3 IU/kg of Biocon's Insulin‐R and Humulin® R. Plasma insulin concentrations and glucose infusion rates (GIRs) were assessed over 12 hours...

  • #endo-diabetology

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