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The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRR | Experimental | Administration order: PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (R), PEG-rhGH with present preparation (R) |
|
| RTR | Experimental | Administration order: PEG-rhGH with present preparation (R), PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (R) |
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| RRT | Experimental | Administration order: PEG-rhGH with present preparation (R), PEG-rhGH with present preparation (R), PEG-rhGH with new preparation (T) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-rhGH with new preparation (T) | 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 -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 | 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 | 0 hours -192hours post-administration |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability(Number of participants with treatment-related adverse events) | up to approximately 83 days |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-drug antibody (Number of Participants with positive ADA) | 0 hours -192 hours post-administration |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chengdu Xinhua Hospital | 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 (R) | Drug | A single subcutaneous injection of PEG-rhGH with present preparation |
|