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

This was a multi‐centric, open‐label, randomized, prospective, comparative, parallel‐group, active‐controlled, phase III clinical trial (in the Russian Federation). The purpose of this study was to evaluate non‐inferiority for efficacy and safety of Ferrum Lek® (iron (III) hydroxide polymaltosate), compared to MALTOFER®, in the treatment of patients with mild and moderate iron‐deficiency anaemia. Participants underwent screening for up to 7 days. Eligible participants were randomized in 1:1 ratio to two treatment arms. Subjects in Group 1 received 2 tablets per day (200 mg) of chewable tablets Ferrum Lek® during or immediately after meals; once daily. Subjects in Group 2 (reference product) received 2 tablets per day (200 mg) of chewable tablets Maltofer® during or immediately after meals; once daily. The subjects received the medicinal products daily for 12 weeks. After the last scheduled study site visit, a follow‐up visit (by phone) was scheduled 14 days after the completion of the active treatment period (day 98±2) to record any delayed adverse events.