MedTrace Logo

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

NCT06627478 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2025-07-16

No results posted yet for this study

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®

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

Sponsors & Collaborators

  • Xentria, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-29
Primary Completion
2025-07-03
Completion
2025-07-03
FDA Drug
Yes

Countries

  • South Africa

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06627478 on ClinicalTrials.gov