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A Study to Compare Eutropin Formulations in Healthy Volunteers for Bioavailability, Safety, and Tolerability

NCT06743997 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-04-17

No results posted yet for this study

Summary

A randomized, Open Label, Single Subcutaneous Dose, 2x2 Crossover Study to Investigate the Relative Bioavailability, Safety and Tolerability among Different Eutropin Formulations in Healthy Volunteers

Conditions

  • Healthy Volunteers

Interventions

DRUG

Test Drug (Eutropin Catridge, 48IU/Cartridge)

Liqid somatropin

DRUG

Reference Drug (Eutropin, 4 IU/vial)

Lyophilized somatropin

Sponsors & Collaborators

  • LG Chem

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-13
Primary Completion
2025-04-15
Completion
2025-04-15

Countries

  • South Korea

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 NCT06743997 on ClinicalTrials.gov