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

Heathy Volunteers Clinical Trial

Official title:
Open-label, Randomized, Crossover-design Bioequivalence Study With Comparing a Single Dose of Ferrinemia® Injection With a Single Dose of Venofer® Injection of Vifor AG in Healthy Male Volunteers

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Heathy Volunteers

Clinical Trial Details

NCT number	NCT03093883
Study type	Interventional
Source	Azad Pharma AG
Contact
Status	Completed
Phase	Phase 1
Start date	March 13, 2017
Completion date	June 26, 2018

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