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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Test Drug (Eutropin Catridge, 48IU/Cartridge); Drug: Reference Drug (Eutropin, 4 IU/vial)

• Registration Number: NCT06743997
• Lead Sponsor: LG Chem

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-18
• Study First Posted: 2024-12-20
• Study Start: 2025-01-13
• Primary Completion: 2025-04-15
• Study Completion: 2025-04-15
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	Test Drug (Eutropin Catridge, 48IU/Cartridge)	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.
Sequence 1	Reference Drug (Eutropin, 4 IU/vial)	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.
Sequence 2	Test Drug (Eutropin Catridge, 48IU/Cartridge)	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.
Sequence 2	Reference Drug (Eutropin, 4 IU/vial)	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.

Primary Outcome Measures

Name	Time	Method
AUClast of somatropin	0 to 24 hours post-dose	AUClast will be used to evaluate the pharmacokinetics of somatropin

Secondary Outcome Measures

Name	Time	Method
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.
Tmax of soatropin	0 to 24 hours post-dose	Tmax will be used to evaluate the pharmacokinetics 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 IGF-1 levels	0 to 24 hours post-dose	Change in IGF-1 levels will be used to evaluate the parmacodynamic effect 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.

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of