Overview

Bioequivalence Study Comparing Single Dose of Ferrinemia® Injection With a Single Dose of Venofer® Injection in Healthy Male Volunteers

Status:
Completed

Trial end date:
2018-06-26

Target enrollment:

Participant gender:

Summary

The aim of this pharmacokinetic study is to assess the bioequivalence of the generic Ferrinemia® Iron Sucrose injection solution 20 mg/mL manufactured by Help S.A., Greece (test product), to Venofer® Iron Sucrose injection solution 20 mg/mL manufactured by Vifor AG, Switzerland (reference product). Both formulations contain iron as an active ingredient. Intravenous iron sucrose is primarily indicated for the treatment of iron deficiency anemia in adult patients.

Phase:

Phase 1

Details

Lead Sponsor:

Azad Pharma AG

Treatments:

Ferric Compounds
Ferric Oxide, Saccharated
Pharmaceutical Solutions