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

Phase 1

Completed

• Conditions: Bioavailability, Safety and Tolerability Among Different Eutropin Formulations in Healthy Volunteers
• Interventions: Drug: Somatropin

• Registration Number: NCT04085224
• Lead Sponsor: LG Chem

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-09
• Study Start: 2019-09-10
• Study First Posted: 2019-09-11
• Primary Completion: 2020-01-02
• Study Completion: 2020-01-02
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-22
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Somatropin	-
3	Somatropin	-
2	Somatropin	-

Primary Outcome Measures

Name	Time	Method
Bioavailability	2years

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of