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The purpose of this study is to compare the pharmacokinetics of the two different PEG-rhGH preparations after a single administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-rhGH with new preparation | Experimental |
| |
| PEG-rhGH with present preparation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-rhGH with new preparation | Drug | A single subcutaneous injection of PEG-rhGH with new preparation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation | 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 | 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 | 0 hours -168 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (The time to reach the peak drug concentration (Tmax)) of PEG-rhGH with present and new preparation. | 0 hours -168 hours | |
| Pharmacokinetics (Half-life (t1/2)) of PEG-rhGH with present and new preparation. | 0 hours -168 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-drug antibody (Number of Participants with positive ADA) | 0 hours -168 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chengdu Xinhua Hospital affiliated to North Sichuan Medical College | Chengdu | Sichuan | 610000 | China |
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| ID | Term |
|---|---|
| C562190 | polyethylene glycol-recombinant human growth hormone |
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| PEG-rhGH with present preparation | Drug | A single subcutaneous injection of PEG-rhGH with present preparation |
|
| Pharmacokinetics (Terminal elimination rate constant (λz)) of PEG-rhGH with present and new preparation. | 0 hours -168 hours |
| Safety and tolerability(Number of participants with treatment-related adverse events) | 0 hours -168 hours |
| Safety and tolerability (Number of Participants with Abnormal Vital Signs That Are Related to Treatment) | 0 hours -168 hours |
| Safety and tolerability (Number of Participants with Abnormal 12-lead ECG QTc Interval That Are Related to Treatment) | 0 hours -168 hours |
| Safety and tolerability (Number of Participants with Abnormal Laboratory Values That Are Related to Treatment) | 0 hours -168 hours |