A Comparative Study of the Pharmacokinetics, Safety, and Tolerability of Epoetin Alfa Following Multiple Intravenous Doses in Healthy Male Participants

The primary objective of this study is to evaluate the bioequivalence of epoetin alfa (Blau EPO) compared to Erypo through the measurement of blood levels following multiple intravenous injections. This comparison is clinically relevant for ensuring therapeutic equivalence in the management of symptomatic anemia associated with chronic renal failure. Secondary objectives include the assessment of safety, tolerability, and the impact 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 30 years. The cohort is comprised of males. The clinical focus involves the treatment of symptomatic anemia associated with chronic renal failure.

This Phase 3 clinical trial is designed as a comparative study involving healthy male participants to evaluate the blood levels, safety, and tolerability of epoetin alfa (Blau EPO) in comparison to Erypo. The study utilizes intravenous administration through multiple injections to assess the impact on specific blood values. The research methodology involves a sequence of study visits, commencing with a screening visit to determine eligibility. Subsequent follow-up visits and an end-of-study visit are scheduled to monitor clinical parameters. The overall duration of participant involvement is determined by the study protocol, and early termination may occur based on predefined clinical conditions or safety criteria.

The efficacy assessment in this phase 3 clinical trial focuses on the treatment of symptomatic anemia associated with chronic renal failure. Specific efficacy parameters and measurement schedules are not defined in the provided data.