NCT06627478View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

114

Participants

Timeline

Start Date

October 29, 2024

Primary Completion Date

July 3, 2025

Study Completion Date

July 3, 2025

Conditions
Healthy Participants
Interventions
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

Trial Locations (1)

9301

FARMOVS Clinical Research Organisation, Bloemfontein

All Listed Sponsors
lead

Xentria, Inc.

INDUSTRY

NCT06627478 - Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS Glargine (G), United States (US)-Lantus®, and European Union (EU)-Lantus® | Biotech Hunter | Biotech Hunter