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The main purpose of the study is to determine whether the test product and the reference product are bioequivalent based on the pharmacokinetics after administration of ug/kg as a single intravenous dose and as a single subcutaneous dose of each of the formulations. The study is consisted of randomization, 2 parts, 4 treatments, 2 way cross over.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Administration | Experimental | The iv solutions containing DA-3880 and Aranesp will be indistinguishable in appearance. |
|
| SC Administration | Experimental | The sc solutions containing DA-3880 and Aranesp will be indistinguishable in appearance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA3880 | Drug |
| ||
| Aranesp |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of DA-3880 and Aranesp via IV Administration | AUC0-t, Cmax, Tmax, t½, AUC0-inf, %AUC of DA-3880 and EU sourced Aranesp® (Amgen) after administration of 1 μg/kg as a single iv dose will be assessed. | 6 weeks |
| Pharmacokinetics of DA-3880 and Aranesp via SC Administration | AUC0-t, Cmax, Tmax, t½, AUC0-inf, %AUC of DA-3880 and EU sourced Aranesp® (Amgen) after administration of 1 μg/kg as a single sc dose will be assessed | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic Variables of DA-3880 and Aranesp | AUEC0-t, Emax, Tmax of DA-3880 and EU sourced Aranesp® after administration of 1 μg/kg as a single iv dose and as a single sc dose will be assessed. | 6 weeks |
| Safety and Tolerability Parameters of DA-3880 and Aranesp |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA | Zuidlaren | 9471 | Netherlands |
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| ID | Term |
|---|---|
| D000068256 | Darbepoetin alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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Adverse events, vital signs, 12-lead ECG, clinical laboratory tests, physical examination, immunogenicity (anti-drug antibodies), local tolerability of DA-3880 and EU sourced Aranesp® after administration of 1 μg/kg as a single iv dose and as a single sc dose will be assessed. |
| 6 weeks |
| Pharmacodynamic and Pharmacodynamic Variables of IV and SC Administration | AUC0-t, Cmax, Tmax, t½, AUC0-inf, %AUC, AUEC0-t, Emax, Tmax of DA-3880 (1 μg/kg) and EU sourced Aranesp® (1 μg/kg) after iv administration with those after sc administration will be assessed. | 6 weeks |
| Safety and Tolerability Parameters of SC and IV Administration | Adverse events, vital signs, 12-lead ECG, clinical laboratory tests, physical examination, immunogenicity (anti-drug antibodies), local tolerability of DA-3880 (1 μg/kg) and EU sourced Aranesp® (1 μg/kg) after iv administration with those after sc administration will be compared and assessed. | 6 weeks |
| D002241 |
| Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |