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OpenTrials
Completed

NCT Number: NCT04085224

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

Completed

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Key information

Conditions

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

Age range

19 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somatropin

Drug

LG Somatropin

Primary outcomes

  1. Bioavailability

    Time frame: 2years

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 11, 2019
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.