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This Phase I study is to compare pharmacokinetics, safety and pharmacodynamics of EPORON and EPREX after single subcutaneous administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPORON→EPREX | Experimental | EPORON PFS(PreFilled Syringe) 4000 IU/0.4 mL(Erythropoietin alfa 4000 IU) will be administered subcutaneously after 10 hours fasting on Day 1. And wash out for 4 weeks. EPREX INJ.(Injection) 4000 IU(Erythropoietin alfa 4000 IU) will be administered subcutaneously after 10 hours fasting on Day 29. |
|
| EPREX→EPORON | Experimental | EPREX INJ. 4000 IU(Erythropoietin alfa 4000 IU) will be administered subcutaneously after 10 hours fasting on Day 1. And wash out for 4 weeks. EPORON PFS 4000 IU/0.4 mL(Erythropoietin alfa 4000 IU) will be administered subcutaneously after 10 hours fasting on Day 29. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPORON | Drug | single dose administration subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve last(AUClast) of Erythropoietin | Twice every 10 minutes within 1hr before administration (day 1/day 29); immediately before administration; 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 (day 6/day 34), 144 (day 7/day 35) hrs after administration for each period | |
| Maximum of concentration(Cmax) of Erythropoietin | Twice every 10 minutes within 1hr before administration (day 1/day 29); immediately before administration; 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 (day 6/day 34), 144 (day 7/day 35) hrs after administration for each period | |
| Reticulocyte count (%) compared to baseline | The absolute difference from the most increased case and its relative percentage (%) when comparing the results before administration | Twice every 10 minutes within 1hr before administration (day 1/day 29); immediately before administration; 12, 24, 48, 72, 96, 120 (day 6/day 34), 144 (day 7/day 35), 216 (day 10/day 38), 312 (day 14/day 42) hrs after administration for each period |
| Measure | Description | Time Frame |
|---|---|---|
| Time of maximum concentration(Tmax) of Erythropoietin | Twice every 10 minutes within 1hr before administration (day 1/day 29); immediately before administration; 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 (day 6/day 34), 144 (day 7/day 35) hrs after administration for each period | |
| Terminal half-life(t1/2) of Erythropoietin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kyung-sang Yu, MD, Ph.D | Contact | 82-02-2072-1920 | ksyu@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Kyung-sang Yu, MD, Ph.D | Clinical Pharmacology Class of Seoul National University College of Medicine / Clinical Pharmacology of Seoul National University Hospital | Principal Investigator |
| In-jin Jang, MD, Ph.D | Clinical Pharmacology Class of Seoul National University College of Medicine / Clinical Pharmacology of Seoul National University Hospital |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital Clinical Trials Center | Seoul | 03080 | South Korea |
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| ID | Term |
|---|---|
| D000068817 | Epoetin Alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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| EPREX | Drug | single dose administration subcutaneously |
|
|
| Twice every 10 minutes within 1hr before administration (day 1/day 29); immediately before administration; 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 (day 6/day 34), 144 (day 7/day 35) hrs after administration for each period |
| Area Under Curve infinity(AUCinf) of Erythropoietin | Twice every 10 minutes within 1hr before administration (day 1/day 29); immediately before administration; 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 (day 6/day 34), 144 (day 7/day 35) hrs after administration for each period |
| Apparent Clearance(CL/F) of Erythropoietin | Twice every 10 minutes within 1hr before administration (day 1/day 29); immediately before administration; 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 (day 6/day 34), 144 (day 7/day 35) hrs after administration for each period |
| Mean Residence Time last(MRTlast) of Erythropoietin | Twice every 10 minutes within 1hr before administration (day 1/day 29); immediately before administration; 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 (day 6/day 34), 144 (day 7/day 35) hrs after administration for each period |
| Hemoglobin | Twice every 10 minutes within 1hr before administration (day 1/day 29); immediately before administration; 12, 24, 48, 72, 96, 120 (day 6/day 34), 144 (day 7/day 35), 216 (day 10/day 38), 312 (day 14/day 42) hrs after administration for each period |
| Hematocrit | Twice every 10 minutes within 1hr before administration (day 1/day 29); immediately before administration; 12, 24, 48, 72, 96, 120 (day 6/day 34), 144 (day 7/day 35), 216 (day 10/day 38), 312 (day 14/day 42) hrs after administration for each period |
| RBC count | Twice every 10 minutes within 1hr before administration (day 1/day 29); immediately before administration; 12, 24, 48, 72, 96, 120 (day 6/day 34), 144 (day 7/day 35), 216 (day 10/day 38), 312 (day 14/day 42) hrs after administration for each period |
| Study Director |
| Hyung-gi Lee, MD, Ph.D | Clinical Pharmacology Class of Seoul National University College of Medicine / Clinical Pharmacology of Seoul National University Hospital | Study Director |
| Ju-yeon Cho, Ph.D | Clinical Pharmacology Class of Seoul National University College of Medicine / Clinical Pharmacology of Seoul National University Hospital | Study Director |
| Seung-hwan Lee, MD, Ph.D | Seoul National University Hospital Clinical Trials Center / Clinical Pharmacology of Seoul National University Hospital | Study Director |
| D002241 |
| Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |