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NCT06840691
PHASE1

A Bioequivalence Study of Two Different Processes of PEG-rhGH Preparations

Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Official title: A Randomized, Open-lable, Single-dose, 3-sequence, 3-period Crossover Bioequivalence Study of Two Different PEG-rhGH (2mg/mL)Preparations in Chinese Healthy Adults

Key Details

Gender

MALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

87

Start Date

2025-05

Completion Date

2025-09

Last Updated

2025-02-21

Healthy Volunteers

Yes

Interventions

DRUG

PEG-rhGH with new preparation (T)

A single subcutaneous injection of PEG-rhGH with new preparation

DRUG

PEG-rhGH with present preparation (T)

A single subcutaneous injection of PEG-rhGH with present preparation

Locations (1)

Chengdu Xinhua Hospital

Chengdu, Sichuan, China