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

LG Chem

Status and phase: Completed; Phase 1

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

Treatments: Drug: Somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04085224

LG-HGCL010

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 19 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 3 patient groups

1

Active Comparator group

Treatment:

Drug: Somatropin

2

Experimental group

Treatment:

Drug: Somatropin

3

Experimental group

Treatment:

Drug: Somatropin