CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled
Drug / intervention
Insulex® R (soluble human insulin, biosimilar) +1 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/NCT07364669
NCT07364669Phase 1Completed
CompareCT.gov

A Randomized, Double-Blind, Cross Over Study to Assess Pharmacokinetic and Pharmacodynamic Effects of Insulex® R in Comparison to Humulin® R in Healthy Subjects

Laboratorios Pisa S.A. de C.V.·interventional·Posted Jan 23, 2026·Updated Jan 23, 2026

In Brief

A Phase 1 clinical trial evaluating Insulex® R (soluble human insulin, biosimilar) and Humulin® R (soluble human insulin, biosimilar) for Healthy Subjects. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The goal of this clinical trial is to evaluate whether Insulex® R demonstrates similar pharmacokinetic (PK) and pharmacodynamic (PD) profiles compared to Humulin® R after a single subcutaneous dose of 0.3 units/kg in healthy adult volunteers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Subjects
CountriesUnited States
CollaboratorsProSciento, Inc.

Timeline

Phase 1CompletedFinished
20252026
First PostedJan 23, 2026
Enrollment StartOct 24, 2024
Primary CompletionFeb 1, 2025
Study CompletionMay 7, 2025
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5 months ago

Interventions

Insulex® R (soluble human insulin, biosimilar)drug

Investigational insulin, Insulex® R (soluble human insulin, biosimilar)

Humulin® R (soluble human insulin, biosimilar)drug

Marketed reference insulin, Humulin® R (soluble human insulin, biosimilar)