NCT07364669

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

A Randomized, Double-Blind, Cross Over Study to Assess Pharmacokinetic and Pharmacodynamic Effects of Insulex® R in Comparison to Humulin® R in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Laboratorios Pisa S.A. de C.V. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to evaluate whether Insulex® R demonstrates similar pharmacokinetic (PK) and pharmacodynamic (PD) profiles compared to Humulin® R after a single subcutaneous dose of 0.3 units/kg in healthy adult volunteers.

Detailed description

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Insulex® R (soluble human insulin, biosimilar)	Investigational insulin, Insulex® R (soluble human insulin, biosimilar)
DRUG	Humulin® R (soluble human insulin, biosimilar)	Marketed reference insulin, Humulin® R (soluble human insulin, biosimilar)

Timeline

• Start date: 2024-10-24
• Primary completion: 2025-02-01
• Completion: 2025-05-07
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study