Health Condition 1: D508- Other iron deficiency anemias
Conditions
Interventions
Intervention1: Polyfer Iron Polymaltose 370 mg tablet eq to Elemental iron 100 mg Manufactured by Titan Laboratories Pvt Ltd India: A Single oral dose of Polyfer Iron Polymaltose 370 mg tablet will be
Sponsors
Neo Health OTC Pty Ltd
Spinos Life Science and Research Private limited
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients with iron deficiency anemia of age between 18 to 45 years and Body Mass Index BMI ranges between 18 50 kg per m2 to 30 00 kg per m2 Patients with a diagnosis of iron deficiency based on Haemoglobin level less than 11 0 g per dL but above 8 g per dL Serum ferritin level less than 30 microgram per Litre for males and less than 20 microgram Per Litre for females Vitamin B12 206 to 678 ng per L Transferrin 200 to 360 mg per dL TSAT 16 to 50 Percent Folic acid 2.6 to 12.2 microgram per Litre Patients who have no evidence of underlying disease during screening and check in and whose screening is performed within 21 days of checkin Patients whose screening laboatory values are within normal limits or considered by the physician or principal or clinical investigator to be of no clinical significance Healthy as documented by the medical history physical examination including but not limited to an evaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervous system and vital sign assessments Generally healthy as documented by a 12 lead electrocardiogram ECG chest X Ray and clinical laboratory assessments Willing to consume ovo lacto vegiterian diet willing to comply with all requirements of this study protocol as well as instructions from the study personnel Non smokers Generally healthy as documented by gynaecological examination and brest xamination for female patients Females of child bearing potential but the result of pregnancy test at screening is negative and the patients agrees to use one of the following contraception methods constantly and properly ie in accordance with the approved prescibing information and the doctors orders during the whole period of participation in the study Total sexual abstinence Oral contraceptives combination drugs containing progestrogen or progestrogen alone Injectable progestrogen Levonorgestrel implants Estrogen containing vaginal ring Transdermal contraceptive patches Intrauterine device or intrauterine system A male partner has been sterile vasectomy with documented azoospermia prior to enrollment of a woman provided that he is the only partner of the female patient For the purpose of this definition documented is related to the result of a patient’s medical examination by an investigator responsible person or a patients past medical history review for assessment of eligibility for enrollment obtained during the interview with a patient or from his or her medical records Double barrier method a condom or an occlusive cap diaphragm or cervical vault caps with a spermicide
Exclusion criteria
Exclusion criteria: Volunteers with a history or significant presence of the following will be excluded from participation or enrollment in the study Administration of any iron containing drugs during the last 3 months History of erythropoietin drugs administration Known hypersensitivity to iron therapy both Oral and or IV administration and other components of the study drugs Other types of anemia apart from iron deficiency will be excluded from enrollment in the study Received 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 Patients with hepatic encephalopathy cholestasis myasthenia pre existing liver disease alcohol abuse existing tinnitus pre existing gallbladder disease and Heme metabolism disorders eg sideroblastic anaemia anaemia due to lead thalassaemia Known fructose intolerance glucose galactose malabsorption syndrome and sucrase isomaltase deficiency Pregnant or lactating women or women intending to become pregnant during the study Any major illness in the last three months or any significant ongoing chronic medical illness Failure of iron therapy for iron deficiency in a patients past medical history Heme metabolism disorders eg sideroblastic anaemia anaemia due to lead thalassaemia History of iron overload including haemochromatosis and hemosiderosis Other causes of anemia apart from iron deficiency including Haemolysis determined as per analyses results at screening or as per anamnestic data Vitamin B12 and folic acid deficiency as per the screening data Chronic kidney disease creatinine clearance at screening is below 90 ml per min based on CockcroftGault Formula Systemic connective tissue diseases chronic infectious diseases requiring regular therapy as per the past medical history eg Inflammatory Bowel Disease Rheumatoid Arthritis and other conditions which may in the investigators opinion be accompanied by anaemia of chronic diseases 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 investigators opinion Malignant diseases including blood and lymphoid tissue disorders leukemia 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 Impaired absorption in case of an intestinal pathology enteritis coeliac disease malabsorption small intestinal resection stomach resection including the duodenum Exacerbation of gastric or duodenal ulcer The necessity of quick iron saturation eg in patients with iron-deficiency anaemia with upcoming surgery Continuous vast blood loss and other causes at the discretion of the investigator Known presence of an active infection caused by Helicobacter pylori In case of presence of Helicobacter pylori a patient may be enrolled after eradicative therapy Concomitant diseases and conditions which in the investigators opinion pose risk to a patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the bioequivalence and therapeutic efficacy of Polyfer Iron Polymaltose 370 mg Tablet equivalent to elemental Iron 100 mg Test product with Maltofer Iron III Hydroxide Polymaltose 100 mg Tablet Reference product for the treatment and prevention of mild to moderate iron deficiency including iron deficiency anemia in the Patient populationTimepoint: 21 Time Points -02 00 Hrs -01 00 Hrs 00 00 Hrs 00 50 Hrs 01 00 Hrs 01 50 Hrs 02 00 Hrs 02 50 Hrs 03 00 Hrs 03 33 Hrs 03 67 Hrs 04 00 Hrs 04 33 Hrs 04 67 Hrs 05 00 Hrs 05 50 Hrs 06 00 Hrs 08 00 Hrs 10 00 Hrs 12 00 Hrs 24 00 Hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of the Test Product compared to the Reference Product for the treatment and prevention of mild to moderate iron deficiency including iron deficiency anemia in the Patient populationTimepoint: 21 Time Points -02 00 Hrs -01 00 Hrs 00 00 Hrs 00 50 Hrs 01 00 Hrs 01 50 Hrs 02 00 Hrs 02 50 Hrs 03 00 Hrs 03 33 Hrs 03 67 Hrs 04 00 Hrs 04 33 Hrs 04 67 Hrs 05 00 Hrs 05 50 Hrs 06 00 Hrs 08 00 Hrs 10 00 Hrs 12 00 Hrs 24 00 Hrs | — |
Countries
India
Contacts
Public ContactDr Pradeep T
Spinos Lifescience and research private limited
Outcome results
None listed