6x3 Crossover, Bioavailability, Safety and Tolerability Among Different Eutropin Formulations in Healthy Volunteers

NCT ID: NCT04085224

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-10
• Study Completion Date: 2020-01-02

Brief Summary

A Randomized, Open Label, Single Subcutaneous Dose 6x3 Crossover Study to Investigate the Relative Bioavailability, Safety and Tolerability among Different Eutropin Formulations in Healthy Volunteers

Conditions

Bioavailability, Safety and Tolerability Among Different Eutropin Formulations in Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

Somatropin

Intervention Type: DRUG

LG Somatropin

2

Group Type: EXPERIMENTAL

Somatropin

Intervention Type: DRUG

LG Somatropin

3

Group Type: EXPERIMENTAL

Somatropin

Intervention Type: DRUG

LG Somatropin

Interventions

Somatropin

LG Somatropin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers between the ages of 19 or more and less than 40 years (19 =< age < 40) on the day of screening
• Negative findings in serum / urine hCG test or Subjects who are not pregnant or lactating in women

Exclusion Criteria

• Administered other drug(s) in other clinical study within 180 days prior to the day of screening

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LG Chem

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

LG-HGCL010

Identifier Type: -

Identifier Source: org_study_id