NCT06492226

Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(A), US-NovoLog®, and EU-NovoRapid®

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(A), US-NovoLog®, and EU-NovoRapid® Using the Euglycemic Clamp Technique in Healthy Male Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (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(A), US-NovoLog®, and EU-NovoRapid®

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(A), US-NovoLog®, and EU-NovoRapid® using the euglycemic clamp technique in healthy male adult volunteers

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	NKF-INS(A)	Single subcutaneous dose of 0.3 U/kg administration over three treatment periods
DRUG	EU-NovoRapid®	Single subcutaneous dose of 0.3 U/kg administration over three treatment periods
DRUG	US-NovoLog®	Single subcutaneous dose of 0.3 U/kg administration over three treatment periods

Timeline

• Start date: 2024-07-30
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2024-07-09
• Last updated: 2026-01-21
• Results posted: 2026-01-21

Locations

1 site across 1 country: South Africa

Regulatory

• FDA-regulated drug study