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To Compare Pharmacokinetic and Pharmacodynamic Profiles of BEPO-A and REPO-A in Healthy Male Subjects
To Compare Pharmacokinetic and Pharmacodynamic Profiles of EPO (BEPO-A (4000 IU)) and EPO (REPO-A (4000 IU)) in Healthy Male Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BEPO-A | Experimental | Single subcutaneous injection of BEPO-A 4000 IU (Bioreactor manufacturing process) |
|
| REPO-A | Active Comparator | Single subcutaneous injection of REPO-A 4000 IU (Roller bottle manufacturing process) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BEPO-A | Drug | BEPO-A (Bioreactor manufacturing process) |
| |
| REPO-A |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax and AUClast | 1D before dosing, 1h, 2, 4h, 7h, 10h,12h, 14h, 2D 0h, 2D 8h, 3D 0h, 4D 0h, 5D 0h, 6D 0h, |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf, Tmax, t1/2β, CL/F, MRTinf (mean residence time) of Erythropoietin | 1D before dosing, 1h, 2, 4h, 7h, 10h,12h, 14h, 2D 0h, 2D 8h, 3D 0h, 4D 0h, 5D 0h, 6D 0h, |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
REPO-A (Roller bottle manufacturing process) |
|