CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 54 enrolled
Drug / intervention
NKF-INS(A) +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06492226
NCT06492226Phase 1Completed
CompareCT.gov

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

Xentria, Inc.·interventional·Posted Jul 9, 2024·Updated Jan 21, 2026

In Brief

A Phase 1 clinical trial evaluating NKF-INS(A), EU-NovoRapid®, and 1 other intervention for Healthy Participants. Completed, enrolled 54 participants across 1 site.

Detailed 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®

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Participants
CountriesSouth Africa
Collaborators--

Timeline

Phase 1CompletedFinished
20252026
First PostedJul 9, 2024
Enrollment StartJul 30, 2024
Primary CompletionOct 31, 2024
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 2.0 years ago

Interventions

NKF-INS(A)drug

Single subcutaneous dose of 0.3 U/kg administration over three treatment periods

EU-NovoRapid®drug

Single subcutaneous dose of 0.3 U/kg administration over three treatment periods

US-NovoLog®drug

Single subcutaneous dose of 0.3 U/kg administration over three treatment periods