6x3 Crossover, Bioavailability, Safety and Tolerability Among Different Eutropin Formulations in Healthy Volunteers
Sponsor
LG Chem (Industry)
Overall Status
Completed
CT.gov ID
NCT04085224
Collaborator
(none)
24
1
3
3.7
6.4
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Investigator)
Primary Purpose:
Other
Official 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
Actual Study Start Date
:
Sep 10, 2019
Actual Primary Completion Date
:
Jan 2, 2020
Actual Study Completion Date
:
Jan 2, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 1
|
Drug: Somatropin
LG Somatropin
|
| Experimental: 2
|
Drug: Somatropin
LG Somatropin
|
| Experimental: 3
|
Drug: Somatropin
LG Somatropin
|
Outcome Measures
Primary Outcome Measures
- Bioavailability [2years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Healthy volunteers between the ages of 19 or more and less than 40 years (19 =< age <
- 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Asan Medical Center | Seoul | Korea, Republic of |
Sponsors and Collaborators
- LG Chem
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
LG Chem
ClinicalTrials.gov Identifier:
NCT04085224
Other Study ID Numbers:
- LG-HGCL010
First Posted:
Sep 11, 2019
Last Update Posted:
Mar 24, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No