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

LG Chem

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Test Drug (Eutropin Catridge, 48IU/Cartridge); Drug: Reference Drug (Eutropin, 4 IU/vial)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06743997

LG-HGCL011

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 19 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Sequence 1

Experimental group

Description:

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.

Treatment:

Drug: Reference Drug (Eutropin, 4 IU/vial)

Drug: Test Drug (Eutropin Catridge, 48IU/Cartridge)

Sequence 2

Experimental group

Description:

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.

Treatment:

Drug: Reference Drug (Eutropin, 4 IU/vial)

Drug: Test Drug (Eutropin Catridge, 48IU/Cartridge)