CTRI/2025/10/096170 [Registered on: 17/10/2025] Trial Registered Prospectively
Last Modified On:
27/12/2025
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Ferric Carboxymaltose Injection 750 mg/15mL (50 mg/mL) Bioequivalent Study
Scientific Title of Study
An Open label, Multicenter, Randomized, Single-dose, Parallel, two-treatment, Bioequivalence
study of Ferric Carboxymaltose Injection 750 mg/15mL (50 mg/mL) of RK Pharma Inc. with
INJECTAFER
(Ferric Carboxymaltose Injection 750 mg/15 mL [50mg/mL]) of American
Regent, Inc. Shirley, NY 11967, following a single intravenous dose of 750mg in adult human
patients with iron deficiency anemia
Trial Acronym
Ferric Carboxymaltose Injection
Secondary IDs if Any
Secondary ID
Identifier
085/21,Version. 01, Amendment-02, 17-Jul-2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Pardha Saradhi Bhavaraju
Designation
DGM-QA
Affiliation
Actimus Biosciences Pvt Ltd
Address
Departmnet of Quality assuarance, Room Number-104, D-2, D-Block, Autonagar, Gajuwaka.
Visakhapatnam ANDHRA PRADESH 53012 India
Phone
9959568777
Fax
Email
saradhi@actimusbio.com
Details of Contact Person Scientific Query
Name
V Ramakrishna
Designation
Manager
Affiliation
Actimus Biosciences Pvt Ltd
Address
Deaprtment of Medical writing , Room No-201, D-2, D-Block, Autonagar, Gajuwaka.
Visakhapatnam ANDHRA PRADESH 530012 India
Phone
7989252542
Fax
Email
ramakrishna@actimusbio.com
Details of Contact Person Public Query
Name
Sriram Eswaran
Designation
General Manager
Affiliation
Actimus Biosciences Pvt Ltd
Address
Department of clinical operations, Room No-202, D-2, D-Block, Autonagar, Gajuwaka.
Dose: 750mg/15ml,
Frequency: Single dose,
Route of administration: Slow IV Injection,
Duration: 7.5mins.
Comparator Agent
INJECTAFER
(Ferric Carboxymaltose Injection) 750 mg/15
mL [50 mg/mL])
Dose: 750mg/15ml,
Frequency: Single dose,
Route of administration: Slow IV Injection,
Duration: 7.5mins
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1) Patient or LAR willing to provide informed consent to participate.
2)Male or non-pregnant, non-lactating females aged 18-65 years (inclusive).
3) Patients diagnosed with iron deficiency anemia, for whom oral supplementation alone is
not adequate/not appropriate or with non-dialysis dependent chronic renal disease (as
defined by either
i)GFR is less than 60ml/min/1.73m2 on screening (As calculated by MDRD), or
ii)GFR is lessthan90ml/min/1.73m2 during screening and at least 1 marker of kidney damage based on medical history within 3 months of screening.
Markers of kidney disease may include: albuminuria (ACR less than 3mg/mmol),
hematuria, and electrolyte abnormalities due to tubular disorders, renal histological
abnormalities, structural abnormalities detected by imaging or a history of kidney
transplantation.
4) Patients considered to be suitable for treatment with Ferric Carboxymaltose Injection
based on Investigator judgement.
5) Patients with body weight more than or equals to 50 kg at screening and check in, with BMI of 18.50 to 30.00 kg/m2 at the time of screening.
6) Patients with hemoglobin levels of more than or equals to 9.0 g/dL and less than 12g/dL at screening.
7) Patients with Iron status evaluation at screening defined as: Serum Ferritin of less than or equals to 100 ng/mL (or less than or equal to 300ng/mL when TSAT is less than or equal to 30%).
8)Patients with normal Serum Phosphate level 3.4 to 4.5 mg/dl (1.12 to 1.45 mmol/L).
9) Patients with adequate hematopoietic and liver function at screening, defined as
iii)ANC more than or equal to 1500/mm3, Platelet count more than or equal to 100,000/mm3.
iv)AST and ALT less than or equal to 3 times ULN, Alkaline phosphatase leass than or equal to 2.5 times ULN, Bilirubin less than or equal to 1.5 times ULN.
10) Patient agrees to comply with the study procedures and requirements of the study.
11)Male Patients willing to follow approved birth control methods (a double barrier method)
for the duration of the study as judged by the investigator(s), such as condom with spermicide, condom with diaphragm, or abstinence, vasectomized. Subjects should not
donate sperm during this time.
12) Female patients should have been postmenopausal for at least 1 year, or surgically
sterilized via hysterectomy, bilateral tubal ligation, bilateral oophorectomy; or practicing
an acceptable form of birth control (defined as the use of an intrauterine device; a barrier
method, like condom, with spermicide; any form of hormonal contraceptives; or
abstinence from sexual intercourse) starting 60 days prior to dosing in case of women with
a childbearing potential and prepared to continue for at least 30 days following the last
treatment.
13) Each female study participant should be negative serum pregnancy test at screening and
urine pregnancy test in check-in.
ExclusionCriteria
Details
1)Patients with known hypersensitivity to ferric carboxymaltose, or any of its inactive
components, excipients, or similar product or any other iron preparation.
2)Patients who have received any of the following medications in recent past:
v)Parenteral iron therapy within the last 6 months prior to randomization.
vi)Oral iron therapy within 4 weeks prior to randomization.
Erythropoiesis stimulating agents within 3 months prior to randomization.
vii)Concomitant medications that may affect the PK results based on investigators
discretion.
3) Patients with clinically significant uncontrolled blood pressure or labile hypertension
(systolic blood pressure more than 150 mm/Hg and diastolic blood pressure more than 100
mm/Hg.
4) Patients with Stage 5 Chronic Kidney Disease (CKD) [eGFR less than 15 mL/min/1.73 m2] or
undergoing dialysis for treatment of CKD or under consideration for dialysis during study
period
5) Patients considered to be anemic due to other aetiology such as severe malabsorption
syndrome, immunosuppressant use, aplastic anemia, megaloblastic or haemolytic
anaemia, untreated Vitamin B12 or folate deficiency or hemoglobinopathy etc.
6) Patients with hemochromatosis or other iron storage disorders.
7)Patients with blood loss leading to hemodynamic instability.
8)Patients who had major surgery or invasive intervention within 4 weeks prior to screening,
organ transplant within 6 months prior to screening, or have a surgery or intervention
planned during the course of the study.
9)Patients who received whole blood transfusion or red blood cell transfusion or donated
blood (1 unit or 350 mL) within 90 days prior to randomization.
10)Patients with history of alcohol abuse or drug abuse or drug dependence within last 1 year
from screening.
11)Patients who have HIV or positive hepatitis screen including hepatitis B surface antigen,
HCV antibodies and RPR.
12)Patients with positive urine alcohol test and drugs of abuse in urine during screening and
at check-in.
13) Patients with low serum phosphate levels (i.e.; below 3.4 mg/dl).
14) Patients with clinically significant abnormal blood pressure (Systolic blood pressure below
100 mm/Hg and above 150 mm/Hg; Diastolic blood pressure below 60 mm/Hg and above
100 mm/Hg).
15) Patients who participated in another clinical trial within 60 days prior to randomization.
16) Patients with known active malignancy (i.e., clinical evidence of current malignancy or
not in stable remission for at least 5 years since completion of last treatment with exception
of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia).
17) Patients with significant comorbidities such as congestive heart failure, asthma,
decompensated liver cirrhosis, eczema or atopic allergy, acute/chronic infection of any
type, systemic lupus erythematous, rheumatoid or inflammatory arthritis, inflammatory
bowel disease, rheumatic disease or any other condition, that in the investigator’s
judgement, might increase the risk to the patient or decrease the chance of obtaining
satisfactory PK data.
18) Female patients who are pregnant or planning (women with childbearing potential) to
become pregnant during the study.
Method of Generating Random Sequence
Permuted block randomization, fixed
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
1)To determine the bioequivalence for Ferric Carboxymaltose Injection 750 mg/15mL (50
mg/mL) of RK Pharma Inc. with INJECTAFER(Ferric Carboxymaltose Injectionn750mg/15mL [50 mg/mL]) of American Regent, Inc. Shirley, NY 11967, following a
single intravenous dose of 750mg in adult human patients with iron deficiency anemia.
2)To assess the safety and tolerability of Ferric Carboxymaltose Injection 750mg iron /15
mL by reported adverse events, laboratory, clinical investigations and vital signs.
Blood samples will be collected at various time points from Day-0 to Day-2 in 4ml plain vacutainers.
Secondary Outcome
Outcome
TimePoints
NIL
NIL
Target Sample Size
Total Sample Size="80" Sample Size from India="80" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 1
Date of First Enrollment (India)
29/10/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
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
This is an open label, multicenter, randomized, single-dose, parallel, two treatment, single-period, bioequivalence study. Patients who meet the inclusion and exclusion criteria will undergo safety assessments within 21 days prior to the administration of the investigational medicinal product .All eligible patients, enrolled in the study, will be housed for at least 24.00 hours prior to drug administration and up to 72.00 hours post dose. After an overnight fast for at least 10.00 hours, as per randomization schedule, patients will be administered undiluted study drug Ferric Carboxymaltose Injection 750 mg/15mL (50mg/mL) of RK Pharma Inc. or INJECTAFER® (Ferric Carboxymaltose Injection 750mg/15mL [50 mg/mL]) of American Regent, Inc). The minimum duration of this study will be at least 07 days. Safety may be assessed by the monitoring of adverse clinical events, electrocardiograms, clinical laboratory evaluations, and physical examinations.