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

April 16, 2025 updated by: LG Chem

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy adults aged 19 to 40years at screening.
  • Voluntarily decide to participate and provide written informed consent.
  • Able to receive the investigational product (IP) and pre-treatment drugs.
  • Wiliing and able to comply with study requirements, including follow-up visits and blood/urine sampling.

Exclusion Criteria:

  • History of conditions contraindicating somatropin or pre-treatment drugs.
  • Clinically significant medical history.
  • Participation in another clinical trial and receipt of an investigational product within 80 days prior to the first IP administration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence 1
Participants receive a single subcutaneous dose of the Test Drug(T), in the first period, followed by a washout period, and then a single subcutaneous dose of the Reference Drug(R) in the second period.
Drug: Test Drug (Eutropin Catridge, 48IU/Cartridge)
Liqid somatropin
Other Names:
  • Test Drug
  • T
Drug: Reference Drug (Eutropin, 4 IU/vial)
Lyophilized somatropin
Other Names:
  • R
  • Reference Drug
Experimental: Sequence 2
Participants receive a single subcutaneous dose of the Reference Drug(R), in the first period, followed by a washout period, and then a single subcutaneous dose of the Test Drug(T) in the second period.
Drug: Test Drug (Eutropin Catridge, 48IU/Cartridge)
Liqid somatropin
Other Names:
  • Test Drug
  • T
Drug: Reference Drug (Eutropin, 4 IU/vial)
Lyophilized somatropin
Other Names:
  • R
  • Reference Drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUClast of somatropin
Time Frame: 0 to 24 hours post-dose
AUClast will be used to evaluate the pharmacokinetics of somatropin
0 to 24 hours post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCinf of somatropin
Time Frame: 0 to 24 hours post-dose
AUCinf will be used to evaluate the pharmacokinetics of somatropin.
0 to 24 hours post-dose
Cmax of somatropin
Time Frame: 0 to 24 hours post-dose
Cmax will be used to evaluate the pharmacokinetics of somatropin.
0 to 24 hours post-dose
Tmax of soatropin
Time Frame: 0 to 24 hours post-dose
Tmax will be used to evaluate the pharmacokinetics of somatropin.
0 to 24 hours post-dose
T1/2β of somatropin
Time Frame: 0 to 24 hours post-dose
T1/2β will be used to evaluate the pharmacokinetics of somatropin.
0 to 24 hours post-dose
Change in IGF-1 levels
Time Frame: 0 to 24 hours post-dose
Change in IGF-1 levels will be used to evaluate the parmacodynamic effect of somatropin.
0 to 24 hours post-dose
Change in IGFBP-3 levels
Time Frame: 0 to 24 hours post-dose
Change in IGFBP-3 levels will be used to evaluate the parmacodynamic effect of somatropin.
0 to 24 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Chem

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2025

Primary Completion (Actual)

April 15, 2025

Study Completion (Actual)

April 15, 2025

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

December 18, 2024

First Posted (Actual)

December 20, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2025

Last Update Submitted That Met QC Criteria

April 16, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • LG-HGCL011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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