An Open-label, Randomized, Cross-over, Single-center Study to Compare Single-dose Pharmacokinetic and Pharmacodynamic Characteristics of US-marketed (Epogen®) and Two European-marketed Epoetin Alfas (Eprex® and Binocrit®) in Healthy Subjects.
Binocrit®, Eprex®, Epogen® Batch 1, Epogen® Batch 2
18 Years - 50 Years
Endpoint Classification: -
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Verified 01 Oct 2019 by AstraZeneca
No locations available
|Experimental: Cohort 1|
13 participants receive Binocrit®
Participants will receive Binocrit® 100 IU/kg Intravenously
|Experimental: Cohort 2|
13 participants will receive Eprex®
Participants will receive Eprex® 100 IU/kg Intravenously.
|Active Comparator: Cohort 3|
13 participants will receive Epogen® Batch 1.
Drug: Epogen® Batch 1
Participants will receive Epogen® Batch 1 100 IU/kg Intravenously.
|Active Comparator: Cohort 4|
13 participants will receive Epogen® Batch 2.
Drug: Epogen® Batch 2
Participants will receive Epogen® Batch 2 100 IU/kg Intravenously.