A Comparative Study of the Pharmacokinetics, Safety, and Tolerability of Single Intravenous Doses of Epoetin Alfa and Erythropoietin in Healthy Volunteers

The primary objective of this study is to conduct a bioequivalence assessment between epoetin alfa and Erypo following a single intravenous injection. Establishing comparable blood levels is clinically relevant to ensure therapeutic equivalence in the treatment of anaemia associated with chronic renal failure. Secondary objectives include the evaluation of safety, tolerability, and the assessment of effects on specific blood values.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers within the age range of 18 to 45 years. Both males and females are included in the cohort. The population is categorized as vulnerable.

This Phase 3 clinical trial is designed to compare the blood levels of epoetin alfa and Erypo following a single intravenous injection. The study evaluates the safety, tolerability, and effects on specific hematological parameters in healthy volunteers. The methodology involves a comparative assessment of the two products. The sequence of procedures begins with a screening visit to determine eligibility. Subsequent follow-up visits are conducted to monitor the subjects, concluding with an end-of-study visit. The total duration of the study is estimated to be approximately eight months, with recruitment expected to occur between August 2026 and March 2027.

The assessment of efficacy in this Phase 3 clinical trial focuses on the treatment of symptomatic anaemia associated with chronic renal failure. Specific parameters for evaluating clinical response or improvement are not defined in the provided documentation.