None listed
Conditions
Brief summary
This study is designed as a therapeutic equivalence study to evaluate the efficacy of Iron (III) Hydroxide Polymaltose 100mg Hard Gelatin Capsules in the treatment of iron deficiency anaemia in non-pregnant women and men. This study will include 240 patients diagnosed with iron deficiency anaemia with each of the two types of sample populations (160 Non-Pregnant Women and 80 Men). The study aims to demonstrate that the Iron (III) Hydroxide Polymaltose 100mg Hard Gelatin Capsules is bioequivalent to the Maltofer® 370 mg Tablets (100mg iron as iron polymaltose) in terms of safety and efficacy.
Interventions
Test Product: Iron (III) Hydroxide Polymaltose 100mg Hard Gelatin Capsules. To be taken orally once daily for 8 consecutive weeks (56 days), during or right after a meal.
A Site staff will check the dosing diary during every visit and ensure the administration status of medicinal products.
The Site staff will check the medicinal product administration status every day by calling the patient.
Sponsors
AFT Pharmaceuticals Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Adult male patients, non-pregnant female patients aged 18 years and above with a diagnosis of iron deficiency anaemia on the screening day and willing to provide written informed consent/assent form to participate in the study. • Diagnosed iron deficiency anaemia based on 2 criteria: •a. Haemoglobin level below 110 g/L but should be above 60 g/L. •b. Serum ferritin level below 30 µg/L. • Patients must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits. • Non-pregnant females and males diagnosed with iron deficiency anaemia are eligible. • Female patients of childbearing potential must have a negative urine pregnancy report/ß-hCG results and should follow abstinence or use contraceptive methods with a failure rate of < 1%.
Exclusion criteria
• Administration of any iron-containing drugs during the last 3 months. • History of erythropoietin drug administration. • Hypersensitivity to iron therapy (both Oral and/or IV administration) and other components of the study drugs. • Hormone therapy (including the use of androgens/anabolic steroids) or administration of drugs that inhibit blood formation, less than 3 months before the start of the study. • History of severe allergic reactions or drug intolerance. • Fructose intolerance, glucose-galactose malabsorption syndrome, and sucrase-isomaltase deficiency. • Failure of iron therapy for iron-deficiency anaemia in a patient's past medical history. • Heme metabolism disorders (e.g., sideroachrestic anaemia, lead anaemia, thalassemia). • Iron overload including hemochromatosis and hemosiderosis. • Other causes of anaemia, apart from iron deficiency, including: •a. Haemolysis (determined as per analysis results at screening, or as per anamnestic data). •b. Vitamin B12 and folic acid deficiency (as per the screening data). •c. Chronic kidney disease (creatinine clearance at screening is below 90 ml/min (based on Cockcroft-Gault Formula)). •d. Systemic connective tissue diseases, chronic infectious diseases requiring regular therapy (as per the past medical history), and other conditions which may, in the investigator's opinion, be accompanied by anaemia of chronic diseases. • Dysfunction of the thyroid gland (based on the data obtained at screening). • Laboratory and clinical signs of an active inflammatory process for 10 days before screening. • AST, ALT, and total bilirubin levels exceeding the upper limit of normal 1.5 times and more. • Clinically apparent hypothyroidism, in the investigator's opinion. • Malignant diseases, including blood and lymphoid tissue disorders (leukaemia, Hodgkin disease, myelodysplastic syndrome, myeloma, etc.) at screening or in the past medical history, provided that the remission was less than 5 years before screening. • Signs of bone marrow aplasia at screening or history of bone marrow aplasia. • The necessity of parenteral iron therapy, i.e., the following cases: •a. Impaired absorption in case of intestinal pathology (enteritis, celiac disease, malabsorption, small intestinal resection, stomach resection, including the duodenum). •b. Exacerbation of gastric or duodenal ulcer. •c. The necessity of quick iron saturation, e.g., in patients with iron deficiency anaemia with upcoming surgery. •d. Continuous vast blood loss and other causes, at the discretion of the investigator. •e. Sickle cell anaemia • Known presence of an active infection caused by Helicobacter pylori. In case of the presence of Helicobacter pylori, a patient may be enrolled after eradicative therapy. • Concomitant diseases and conditions, which, in the investigator's opinion, pose a risk to a patient's safety in case of his/her participation in the study, or able to affect the safety data analysis in case of exacerbation of this disease/condition during the study, including: •a. Myocardial infarction or stroke within 6 months before screening. •b. Unstable angina. •c. Severe arrhythmia, not controlled by drug therapy. •d. Decompensated diabetes mellitus. •e. Nephrological disorders. • Other significant diseases, at the discretion of the investigator. • Pregnant patients, lactating women, or women intending to become pregnant during the study.
Outcome results
None listed