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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06743997

Enrollment

Registered

2024-12-20

Start date

2025-01-13

Completion date

2025-04-15

Last updated

2025-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief 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

Interventions

DRUGTest Drug (Eutropin Catridge, 48IU/Cartridge)

Liqid somatropin

DRUGReference Drug (Eutropin, 4 IU/vial)

Lyophilized somatropin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026