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OpenTrials
Completed

NCT Number: NCT06743997

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

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

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Key information

Conditions

Healthy Volunteers

Age range

19 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, 05505, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Test Drug (Eutropin Catridge, 48IU/Cartridge)

Drug

Liqid somatropin

Other names: T, Test Drug

Reference Drug (Eutropin, 4 IU/vial)

Drug

Lyophilized somatropin

Other names: R, Reference Drug

Primary outcomes

  1. AUClast of somatropin

    Time frame: 0 to 24 hours post-dose

    AUClast will be used to evaluate the pharmacokinetics of somatropin

Secondary outcomes

  1. AUCinf of somatropin

    Time frame: 0 to 24 hours post-dose

    AUCinf will be used to evaluate the pharmacokinetics of somatropin.

  2. Cmax of somatropin

    Time frame: 0 to 24 hours post-dose

    Cmax will be used to evaluate the pharmacokinetics of somatropin.

  3. Tmax of soatropin

    Time frame: 0 to 24 hours post-dose

    Tmax will be used to evaluate the pharmacokinetics of somatropin.

  4. T1/2β of somatropin

    Time frame: 0 to 24 hours post-dose

    T1/2β will be used to evaluate the pharmacokinetics of somatropin.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 20, 2024
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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