drugset / Trial / NCT03993288

Study to Test the Hypothesis of Non-inferior Efficacy and Safety of Ferrum Lek® (Iron (III) Hydroxide Polymaltosate), 100 mg Chewable Tablets (Lek d.d., Slovenia), as Compared With MALTOFER® (Vifor S.A., Switzerland), in Subjects With Mild and Moderate Iron Deficiency Anemia.

NCT03993288 ↗

Phase 3 Completed 267 enrolled Sandoz
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study was to evaluate non-inferiority for efficacy and safety of Ferrum Lek® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Lek d.d., Slovenia), compared to MALTOFER® (Vifor S.A., Switzerland), in the treatment of patients with mild and moderate iron-deficiency anaemia.

Timeline

Start
2019-06-27
Primary completion
2020-06-18
Completion
2020-06-18

Drugs

EvaluationDrugModalityDoseRoute
Subject iron (III) hydroxide polymaltosate Unknown 200 mg Oral