| CTRI Number |
CTRI/2025/06/088448 [Registered on: 09/06/2025] Trial Registered Prospectively |
| Last Modified On: |
16/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Double Blind Randomized Trail Comparing Ferric Carboxy Maltose Injection 50mg Iron Per Ml |
|
Scientific Title of Study
|
A Double Blind Balanced Randomized Single Dose Two Treatment Parallel Truncated Bioequivalence Study Comparing Ferric Carboxymaltose Injection 50mg Iron per mL 1000mg per 20mL by Jodas Expoim Private Limited Telangana Manufactured For Nova Pharmaceuticals Australasia Pty Ltd With Ferinject Injection Ferric Carboxymaltose 1000mg per 20mL Manufactured by Vifor Pharma Pty Ltd Level 8 80 Dorcas Street Southbank Melbourne Vic 3006 Australia in Adult Patients With Iron Deficiency Anaemia Under Fasting Conditions |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| SLS-BE-0097-24-FERR Version: 02 Date: 19 Apr 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 pirivuThudiyalur Coimbatore
Coimbatore
TAMIL NADU
641029
India
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 pirivuThudiyalur Coimbatore
Coimbatore
TAMIL NADU
641029
India
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 pirivuThudiyalur Coimbatore
Coimbatore
TAMIL NADU
641029
India
Coimbatore
TAMIL NADU
641029
India |
| Phone |
08220586899 |
| Fax |
|
| Email |
pradeep.t@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| Nova Pharmaceuticals Australasia Pty Ltd Australia |
|
|
Primary Sponsor
|
| Name |
Nova Pharmaceuticals Australasia Pty Ltd |
| Address |
Suite 305
10 Norbrik Drive Bella Vista
NSW Australia 2153
|
| 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 andResearch privatelimited |
Clinical Pharmacology unit GroundFloor No 29 A Krishna MaduravanamVellakinar pirivu ThudiyalurCoimbatore 641029
Coimbatore
TAMIL NADU
Coimbatore
TAMIL NADU |
08220586899
pradeep.t@spinoslifescience.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research EthicsCommittee RegistrationNoECR/84/Indt/TN/2013/RR-19 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D559||Anemia due to enzyme disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
FERINJECT Injection Ferric carboxymaltose 1000mg per 20mL |
Single Dose of FERINJECT Injection Ferric carboxymaltose 1000mg per 20mL Will Be administered in study Period Total Duration is 05 Days |
| Intervention |
Ferric Carboxymaltose Injection 50mg Iron per mL 1000mg per 20mL |
Single Dose of Ferric Carboxymaltose Injection 50mg Iron per mL 1000mg per 20mL Will Be administered in study Period Total Duration is 05 Days |
|
Inclusion Criteria
Modification(s)
|
| 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 ranging between 18 50 kg m2 to 30 00 kg m2 according to the formula of BMI weight kg height m2 and body weight of 50 kg or above
Patients should have prescriptions for treatment with ferric carboxymaltose injections
Diagnosed iron deficiency anemia based on two criteria
a Hemoglobin level below 12 g dL in men and women
b Serum ferritin levels below or equal to 100 ng per mL or below or equal to 300 ng per mL when TSAT is less than or equal to 30 percentage
Patients who have no evidence of underlying disease during screening and check in and whose screening is performed within 21 days of check in
Patients whose screening laboratory values are within normal limits or are considered by the physician or principal 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 an ovo lacto vegetarian 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 gynecological examination and breast examination for female patients during the study period
Females of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to the initiation of the study and a negative urine pregnancy test prior to check in for the study period
If the patient is female currently not pregnant not lactating or not attempting to become pregnant for 4 weeks before the screening visit throughout the duration of the study and 3 weeks after the patients last study related visit for eligible patients only if applicable has a negative serum pregnancy test and is of
Non childbearing potential defined as
At least 1 year post menopausal no menstrual period for at least 12 consecutive months without any other medical cause
Surgically sterile bilateral tubal ligation bilateral oophorectomy or hysterectomy
or is of
Childbearing potential willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study
Double barrier methods condoms cervical cap diaphragm and vaginal contraceptive film with spermicide
Intrauterine device with a low failure rate of less than 1 percent per year
or is of
Childbearing potential and not sexually active willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study in the event the patient becomes sexually active |
|
| ExclusionCriteria |
| Details |
Evidence of allergy or known hypersensitivity to Ferric Carboxymaltose excipients or similar product
Clinically significant or labile hypertension
Blood loss leading to hemodynamic instability
Recent parenteral iron within the last 3 to 6 months
Positive results for Allergic test prior to check in of study period
Patients with hepatic encephalopathy cholestasis myasthenia pre existing liver disease alcohol abuse existing tinnitus and pre existing gallbladder disease
Any major illness in the last three months or any significant ongoing chronic medical illness
Renal or liver impairment
Any disease or condition that might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system or any other body system including presence of Diabetes Mellitus and Psychosis
History of alcohol addiction or abuse
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 alcohol and its products 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 that may affect pharmacokinetic results
Patients who have taken any unusual diet for whatever reason eg low salt for 48 00 hours prior to dosing and throughout the study
Patient who had participated in any other study within the 90 days of check in
History of difficulty in swallowing
History of difficulty in accessibility of veins
Positive results for urine screen of drugs of abuse Marijuana THC amphetamine AMP barbiturates BAR cocaine COC benzodiazepines BZD and morphine MOR in urine prior to check in of this study period
Positive results for alcohol test prior to check in of study period
Any blood donation excess blood loss within 90 days of check in
Ingestion of any hormonal agent at any time within 14 days prior to the start of the study check in
Use of hormone replacement therapy for a period of 06 months prior to dosing
Female patients demonstrating a positive pregnancy screen
Female patients who are currently lactating
Females who are are likely to become pregnant during the course of the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the Bioequivalence on Ferric Carboxymaltose Injection 50mg Iron per mL 1000mg per 20mL by Jodas Expoim Private Limited Telangana Manufactured for Nova Pharmaceuticals Australasia Pty Ltd with FERINJECT Injection Ferric carboxymaltose 1000mg per 20mL Manufactured by Vifor Pharma Pty Ltd Australia In Adult Patients With Iron Deficiency Anaemia Under Fasting Conditions |
27 time points
minus 02 00 hrs minus 01 00 hrs 00 00 hrs 00 08 hrs 00 16 hrs 00 33 hrs 00 50 hrs 00 67 hrs 00 83 hrs 01 00 hrs 01 16 hrs 01 33 hrs 01 50 hrs 01 67 hrs 02 00 hrs 02 50 hrs 03 00 hrs 04 00 hrs 05 00 hrs 06 00 hrs 07 00 hrs 08 00 hrs 10 00 hrs 12 00 hrs 24 00 hrs 48 00 hrs and 72 00 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety and tolerability of testproduct comparing with the reference product in Adult Patients With Iron Deficiency Anaemia Under Fasting Conditions |
27 time points
minus 02 00 hrs minus 01 00 hrs 00 00 hrs 00 08 hrs 00 16 hrs 00 33 hrs 00 50 hrs 00 67 hrs 00 83 hrs 01 00 hrs 01 16 hrs 01 33 hrs 01 50 hrs 01 67 hrs 02 00 hrs 02 50 hrs 03 00 hrs 04 00 hrs 05 00 hrs 06 00 hrs 07 00 hrs 08 00 hrs 10 00 hrs 12 00 hrs 24 00 hrs 48 00 hrs and 72 00 hrs |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "44"
Final Enrollment numbers achieved (India)="44" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/06/2025 |
| Date of Study Completion (India) |
15/08/2025 |
| 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)
Modification(s)
|
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 44 number of healthy Adult Patients With Iron Deficiency
Anaemia will be recruited to evaluate the Bioequivalence of Test product with
the Reference product
In each period patients will be housed in the clinical facility for at
least 11 00 hours pre dose to 72 00 hours post dose
In each period, after an overnight fasting of at least 08 00 hrs, in the
morning a single infusion of either the test product T or reference product R
will be administered as per the randomization schedule up to 15 to 30 minutes at
ambient temperature, to the patients to the patient in the supine position,
under the supervision of Investigator or Medical Officer and trained study
personnel including the Quality Assurance auditor or monitors
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 01 00 hrs 02 00 hrs 04 00 hrs 06 00 hrs 08 00 hrs 12 00
24 00 hrs 36 00 hrs 48 00 hrs plus or minus 60 minutes post dose
Physical examination and vitals will be recorded before check in check
out 72 00 hrs and at any time if necessary.
Monitoring for adverse events will be done throughout the study period
in clinical phase
|