Pharmacokinetic and Pharmacodynamic Effects of Insulex® R in Comparison to Humulin® R in Healthy Subjects

This Phase 1, randomized, double-blind, two-period, two-sequence crossover clinical trial aims to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence of Insulex® R compared to Humulin® R after a single subcutaneous dose of 0.3 units/kg in healthy adult subjects. The study was designed in accordance with international regulatory guidelines, including the U.S. Food and Drug Administration (FDA) guidance for demonstrating biosimilarity of insulin products and the European Medicines Agency (EMA) guidelines for the clinical development of biosimilar insulins. Each subject underwent a Screening Visit (Visit 1), two 1-day in-house Treatment Periods (Visit 2 and Visit 3), and a Follow-up Visit (Visit 4) to performed safety procedures. The washout period between Treatment Periods was 7 to 14 days. During each Treatment Period, subjects will receive a single subcutaneous dose of either Insulex® R or Humulin® R under euglycemic glucose clamp conditions. Blood samples will be collected at prespecified intervals to measure serum insulin and C-peptide concentrations. Glucose infusion rates will be monitored continuously to assess PD response. The rigorous assessment of PK and PD profiles under controlled clamp conditions is essential to confirm biosimilarity and ensure therapeutic equivalence. Successful demonstration of bioequivalence will provide a safe, effective, and cost-accessible recombinant human rapid-acting insulin option for patients requiring insulin therapy.