NCT07165652

Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(L), US-Humalog®, and EU-Humalog®

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(L), US-Humalog®, and EU-Humalog® 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

Study to demonstrate pharmacokinetic and pharmacodynamic similarity between NKF-INS(L), US-Humalog®, and EU-Humalog®

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(L), US-Humalog®, and EU-Humalog® using the euglycemic clamp technique in healthy male adult volunteers

Conditions

• Healthy Male Adult Volunteers

Interventions

Type	Name	Description
DRUG	NKF-INS(L)	Participants will receive a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment period 3.
DRUG	US-Humalog®	Participants will receive a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment period 3.
DRUG	EU-Humalog®	Participants will receive a single subcutaneous dose of 0.3 IU/kg in either Treatment Period 1, Treatment Period 2, or Treatment period 3.

Timeline

• Start date: 2025-10-13
• Primary completion: 2026-03-02
• Completion: 2026-03-02
• First posted: 2025-09-10
• Last updated: 2026-03-06

Locations

1 site across 1 country: South Africa

Regulatory

• FDA-regulated drug study