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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04085224

Enrollment

Registered

2019-09-11

Start date

2019-09-10

Completion date

2020-01-02

Last updated

2020-03-24

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

Conditions

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

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

Interventions

DRUGSomatropin

LG Somatropin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Bioavailability	2years

Countries

South Korea

Outcome results

None listed

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