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Trials / Completed

CompletedNCT06797505

A Bioequivalence Study of Two Different PEG-rhGH Preparations

A Randomized, Open-lable, Single-dose, 3-sequence, 3-period Crossover Bioequivalence Study of Two Different PEG-rhGH Preparations in Chinese Healthy Adults

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
87 (actual)
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
Sex
Male
Age
18 Years – 45 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.

Detailed description

The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.

Conditions

Interventions

TypeNameDescription
DRUGPEG-rhGH with new preparation (T)A single subcutaneous injection of PEG-rhGH with new preparation
DRUGPEG-rhGH with present preparation (T)A single subcutaneous injection of PEG-rhGH with present preparation

Timeline

Start date
2025-02-10
Primary completion
2025-04-29
Completion
2025-05-30
First posted
2025-01-28
Last updated
2025-08-08

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06797505. Inclusion in this directory is not an endorsement.

A Bioequivalence Study of Two Different PEG-rhGH Preparations (NCT06797505) · Clinical Trials Directory