The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
87
A single subcutaneous injection of PEG-rhGH with new preparation
A single subcutaneous injection of PEG-rhGH with present preparation
Chengdu Xinhua Hospital
Chengdu, Sichuan, China
Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation
Time frame: 0 hours -192 hours post-administration
Pharmacokinetics (Area under the concentration-time curve from time zero to time infinity (AUC0-inf)) of PEG-rhGH with present and new preparation
Time frame: 0 hours -192 hours post-administration
Pharmacokinetics (Area under the concentration-time curve from time zero to the time of the last quantifiable (AUC0- last )) of PEG-rhGH with present and new preparation
Time frame: 0 hours -192hours post-administration
Safety and tolerability(Number of participants with treatment-related adverse events)
Time frame: up to approximately 83 days
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