The purpose of this study is to compare the pharmacokinetics of the two different PEG-rhGH preparations after a single administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
48
A single subcutaneous injection of PEG-rhGH with new preparation
A single subcutaneous injection of PEG-rhGH with present preparation
Chengdu Xinhua Hospital affiliated to North Sichuan Medical College
Chengdu, Sichuan, China
Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation
Time frame: 0 hours -168 hours
Pharmacokinetics (Area under the concentration-time curve from time zero to time infinity (AUC0-∞)) of PEG-rhGH with present and new preparation
Time frame: 0 hours -168 hours
Pharmacokinetics (Area under the concentration-time curve from time zero to time t (AUC0-t )) of PEG-rhGH with present and new preparation
Time frame: 0 hours -168 hours
Pharmacokinetics (The time to reach the peak drug concentration (Tmax)) of PEG-rhGH with present and new preparation.
Time frame: 0 hours -168 hours
Pharmacokinetics (Half-life (t1/2)) of PEG-rhGH with present and new preparation.
Time frame: 0 hours -168 hours
Pharmacokinetics (Terminal elimination rate constant (λz)) of PEG-rhGH with present and new preparation.
Time frame: 0 hours -168 hours
Safety and tolerability(Number of participants with treatment-related adverse events)
Time frame: 0 hours -168 hours
Safety and tolerability (Number of Participants with Abnormal Vital Signs That Are Related to Treatment)
Time frame: 0 hours -168 hours
Safety and tolerability (Number of Participants with Abnormal 12-lead ECG QTc Interval That Are Related to Treatment)
Time frame: 0 hours -168 hours
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Safety and tolerability (Number of Participants with Abnormal Laboratory Values That Are Related to Treatment)
Time frame: 0 hours -168 hours