临床试验/CTRI/2025/10/096530

CTRI/2025/10/096530进行中（未招募）不适用

An open label balanced randomized multi dose two treatment single period parallel oral bioequivalence study with clinical endpoints comparing Polyfer Iron Polymaltose 370 mg tablet eq To elemental iron 100mg manufactured by Titan Laboratories Pvt Ltd India with Maltofer Iron III Hydroxide Polymaltose 100 mg tablet manufactured by Aspen Pharmacare Australia Pty Ltd for the treatment and prevention of mild to moderate iron deficiency including Iron deficiency anemia in the Patient population

Neo Health OTC Pty Ltd1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2025年11月10日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 100
试验地点: 1
主要终点: 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 population

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

At least 100 patientswith mild to moderate Iron Deficiency including iron deficiency anemia patients will be recruited to evaluate the bioequivalence of the Test product with the Reference product

As per the discretion of the Investigator a sufficient number of stand by Patients will be included additionally to ensure successful dosing of 100 Patients

If required study will be conducted in multiple groups

During the study period patients will be housed in the clinical facility from at least 11 00 hours Day 00 prior to dosing on Day 01 until 74 00 hours post dose ie Day 04

After the 74 00 hour in house phase patients will be checked out and will continue the study on an outpatient basis

Follow up and Dosing compliance will be monitored via scheduled phone calls and the end of study post study sample End line will be collected on Day 61

Throughout the outpatient phase participants will receive regular telephonic follow ups to monitor adherence and the CRC will conduct a video call on daily basis with the patients upto Day 60

In study period drinking water will be restricted from at least 01 00 hour prior to dosing until 01 00 hours post dose except 240 mL of drinking water during dosing. After 01 00 hours post dose drinking water will be provided ad libium

Blood pressure radial pulse rate body temperature and wellbeing status will be enquired and recorded at pre dose 00 00 hour within 75 minutes of before dosing and at 03 00 06 00 12 00 24 00 and 48 00 hours ± 60 minutes post dose

Physical examination and vitals will be recorded before check in Day 00 check-out 74 00 hours Day 04 ± 60 minutes for Study period and at any time if necessary

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: None

入排标准

年龄范围: 18.00 Year(s) 至 45.00 Year(s)（—）
性别: All

入选标准

•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.

排除标准

•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 safety in case of his or her participation in the study or able to affect the safety data analysis in case of exacerbation of this disease or condition during the study including Myocardial infarction or stroke within 6 months before screening Unstable angina Severe arrhythmia not controlled by drug therapy Uncontrolled diabetes mellitus Nephrological disorders Other significant diseases at the discretion of the investigator HIV infection as per the screening data or the results of analysis performed within 6 months before screening Known or suspected drug or alcohol abuse for the last 2 years Suspected poor adherence of a patient eg due to mental disorders Participation in any clinical drug studies less than 3 months before the study Blood donation blood transfusion within 30 days prior to screening or planned blood transfusion at time of screening History of smoking Consumption of caffeine and or xanthine containing products ie coffee tea chocolate caffeine containing sodas colas etc cigarettes and tobacco containing products for at least 48.00 hours prior to check in and throughout the entire study Consumption of grapefruit and or its juice and poppy containing foods within 48.00 hours prior to clinic admission and throughout the entire study Patients who have taken any prescription medications within 14 days prior to study check in and throughout the study and any over the counter medicinal products herbal medications within 07 days prior to study check in and throughout the study Patients who have taken any unusual diet for whatever reason eg low salt for 48.00 hours prior to dosing and throughout the study History of difficulty in swallowing History of difficulty in accessibility of veins Positive results for urine screen of drugs of abuse in urine prior to check in.

结局指标

主要结局

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 population

时间窗: 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

次要结局

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 population(21 Time Points)

研究者

发起方

Neo Health OTC Pty Ltd

申办方类型

Pharmaceutical industry-Global

责任方

Principal Investigator

主要研究者

Dr Pradeep T

Spinos Lifescience and research private limited

研究点 (1)

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