NCT04085224

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

September 10, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2020

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

September 9, 2019

Last Update Submit

March 22, 2020

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Bioavailability

    2years

Study Arms (3)

1

ACTIVE COMPARATOR
Drug: Somatropin

2

EXPERIMENTAL
Drug: Somatropin

3

EXPERIMENTAL
Drug: Somatropin

Interventions

SomatropinDRUG

LG Somatropin

123

Eligibility Criteria

Age19 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

Human Growth Hormone

Intervention Hierarchy (Ancestors)

Growth HormonePituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2019

First Posted

September 11, 2019

Study Start

September 10, 2019

Primary Completion

January 2, 2020

Study Completion

January 2, 2020

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)