| CTRI Number |
CTRI/2025/10/096530 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An open label multi dose single period oral bioequivalence study comparing Iron for the treatment and prevention of mild to moderate iron deficiency in Patient population |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-BE-0056-25-IRON Version No: 01 Date: 19 Aug 25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and research private limited |
| Address |
Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
Coimbatore
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and research private limited |
| Address |
Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep T |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and research private limited |
| Address |
Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| Neo Health OTC Pty Ltd
Unit 20 1 Central Avenue
Thornleigh NSW 2120 Australia
|
|
|
Primary Sponsor
|
| Name |
Neo Health OTC Pty Ltd |
| Address |
Unit 20 1 Central Avenue Thornleigh NSW 2120 Australia |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Spinos Life Science and Research Private limited |
29 A Krishna Madhuravanam Vellakinar Pirivu Thudiyalur Coimbatore641029 Tamil Nadu India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pradeep T |
Spinos Lifescience and Research private limited |
Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore
Coimbatore
TAMIL NADU |
08220586899
pradeep.t@spinoslifescience.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D508||Other iron deficiency anemias, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Maltofer Iron III Hydroxide Polymaltose 100 mg Tablet Manufactured by Aspen Pharmacare Australia Pty Ltd |
A Single oral dose of Maltofer Iron III Hydroxide Polymaltose 100 mg Tablet will be administered in study period The doses will be administered from Day 01 to Day 04 during housing Total Duration is 62 days |
| Intervention |
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 administered in study period The doses will be administered from Day 01 to Day 04 during housing Total Duration is 62 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 |
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 Outcome
|
| Outcome |
TimePoints |
| 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
-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 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/11/2025 |
| Date of Study Completion (India) |
25/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
At least 100 patients with 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 |