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
60
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 (The 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 (the 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 Laboratory Values and/or Vital Signs That Are Related to Treatment)
Time frame: Day1 0 hours and Day 8 168 hours
Safety and tolerability (Number of Participants with Abnormal 12-lead ECG QTc Interval That Are Related to Treatment)
Time frame: Day1 0 hours and Day 8 168 hours
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Safety and tolerability (Number of Participants with Abnormal Laboratory Values That Are Related to Treatment)
Time frame: Day1 0 hours and Day 8 168 hours