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

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ClinicalTrials.gov Identifier: NCT04085224
Recruitment Status : Not yet recruiting
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Bioavailability, Safety and Tolerability Among Different Eutropin Formulations in Healthy Volunteers Drug: Somatropin Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Somatropin

Arm Intervention/treatment
Active Comparator: 1 Drug: Somatropin
LG Somatropin

Experimental: 2 Drug: Somatropin
LG Somatropin

Experimental: 3 Drug: Somatropin
LG Somatropin




Primary Outcome Measures :
  1. Bioavailability [ Time Frame: 2years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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Responsible Party: LG Chem
ClinicalTrials.gov Identifier: NCT04085224     History of Changes
Other Study ID Numbers: LG-HGCL010
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No