drugset
drugset / Trial / NCT06627478

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

NCT06627478 ↗

Phase 1 Completed 114 enrolled Xentria, Inc.
RandomizedCrossoverDouble-blindOther

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®

Timeline

Start
2024-10-29
Primary completion
2025-07-03
Completion
2025-07-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator EU-Lantus® Unknown 0.5 iu/kg Subcutaneous
Subject NKF-INS(G) Unknown 0.5 iu/kg Subcutaneous
Comparator insulin glargine Protein / enzyme biologic 0.5 iu/kg Subcutaneous

Indications

No indication recorded.