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Pharmacokinetic and Pharmacodynamic Effects of Insulex® R in Comparison to Humulin® R in Healthy Subjects

NCT07364669 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-23

No results posted yet for this study

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.

Conditions

  • Healthy Subjects

Interventions

DRUG

Insulex® R (soluble human insulin, biosimilar)

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

DRUG

Humulin® R (soluble human insulin, biosimilar)

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

Sponsors & Collaborators

  • ProSciento, Inc.

    collaborator INDUSTRY

  • Laboratorios Pisa S.A. de C.V.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-24
Primary Completion
2025-02-01
Completion
2025-05-07
FDA Drug
Yes

Countries

  • United States

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 NCT07364669 on ClinicalTrials.gov