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

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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04085224
• Other study ID #: LG-HGCL010
• Status: Completed
• Phase: Phase 1
• Start date: September 10, 2019
• Est. completion date: January 2, 2020

Study information

• Verified date: March 2020
• Source: LG Chem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2, 2020
• Est. primary completion date: January 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Somatropin
LG Somatropin

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioavailability		2years