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

NCT06492226 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-01-21

Study results available
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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®

Conditions

  • Healthy Participants

Interventions

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

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
2024-07-30
Primary Completion
2024-10-31
Completion
2024-10-31
FDA Drug
Yes

Countries

  • South Africa

Study Locations

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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 NCT06492226 on ClinicalTrials.gov