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A randomized, Open Label, Single Subcutaneous Dose, 2x2 Crossover Study to Investigate the Relative Bioavailability, Safety and Tolerability among Different Eutropin Formulations in Healthy Volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Participants receive a single subcutaneous dose of the Test Drug(T), in the first period, followed by a washout period, and then a single subcutaneous dose of the Reference Drug(R) in the second period. |
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| Sequence 2 | Experimental | Participants receive a single subcutaneous dose of the Reference Drug(R), in the first period, followed by a washout period, and then a single subcutaneous dose of the Test Drug(T) in the second period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Drug (Eutropin Catridge, 48IU/Cartridge) | Drug | Liqid somatropin |
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| Measure | Description | Time Frame |
|---|---|---|
| AUClast of somatropin | AUClast will be used to evaluate the pharmacokinetics of somatropin | 0 to 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of somatropin | AUCinf will be used to evaluate the pharmacokinetics of somatropin. | 0 to 24 hours post-dose |
| Cmax of somatropin | Cmax will be used to evaluate the pharmacokinetics of somatropin. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 05505 | South Korea |
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| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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| Reference Drug (Eutropin, 4 IU/vial) | Drug | Lyophilized somatropin |
|
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| 0 to 24 hours post-dose |
| Tmax of soatropin | Tmax will be used to evaluate the pharmacokinetics of somatropin. | 0 to 24 hours post-dose |
| T1/2β of somatropin | T1/2β will be used to evaluate the pharmacokinetics of somatropin. | 0 to 24 hours post-dose |
| Change in IGF-1 levels | Change in IGF-1 levels will be used to evaluate the parmacodynamic effect of somatropin. | 0 to 24 hours post-dose |
| Change in IGFBP-3 levels | Change in IGFBP-3 levels will be used to evaluate the parmacodynamic effect of somatropin. | 0 to 24 hours post-dose |