NCT06627478

Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS Glargine (G), United States (US)-Lantus®, and European Union (EU)-Lantus®

Single-dose, Double-blind, Randomized, Three-period, Three-treatment, Six-sequence, Crossover Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(G), US-Lantus®, and EU-Lantus®

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Xentria, Inc. · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Single-dose, double-blind, randomized, three-period, three-treatment, six-sequence, crossover study to demonstrate pharmacokinetic and pharmacodynamic similarity between NKF-INS Glargine (G), United States (US)-Lantus®, and European Union (EU)-Lantus®

Detailed description

A single center, single-dose, double-blind, randomized, three-period, three-treatment, six-sequence, crossover study to demonstrate pharmacokinetic and pharmacodynamic similarity between NKF-INS(G), US-Lantus®, and EU-Lantus® using the euglycemic clamp technique in healthy male adult volunteers

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	NKF-INS(G)	Single subcutaneous dose of 0.5 IU/kg administered over three periods
DRUG	US-Lantus®	Single subcutaneous dose of 0.5 IU/kg administered over three periods
DRUG	EU-Lantus®	Single subcutaneous dose of 0.5 IU/kg administered over three periods

Timeline

• Start date: 2024-10-29
• Primary completion: 2025-07-03
• Completion: 2025-07-03
• First posted: 2024-10-04
• Last updated: 2025-07-16

Locations

1 site across 1 country: South Africa

Regulatory

• FDA-regulated drug study