Bioequivalence study of Ferric carboxymaltose solution in patients with iron deficiency anemia.
- Conditions
- Health Condition 1: D509- Iron deficiency anemia, unspecified
- Registration Number
- CTRI/2024/02/062551
- Lead Sponsor
- DifGen Pharmaceuticals LLC,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1.Male and female patients with age 18-65 years -inclusive of both
2.Patients with more than or equal 50 kg body weight and weight within the clinically acceptable normal range according to normal values for Body Mass Index -18.50 to 24.90 kg per m2 both inclusive.
3. Patients that have Iron Deficiency Anemia -IDA at the time of screening based on the following laboratory parameters:
a.Hemoglobin value less than 7 and more than 12 g per dL at screening.
b.Ferritin less than or equal to 100 ng per mL or less than or equal to 300 ng per mL when transferrin saturation -TSAT is less than or equal to 30% at screening.
4.Patients that meet either of the following criteria:
Unsatisfactory response to oral iron in the opinion of the Investigator based on the history of having received oral iron therapy.
Intolerance to oral iron preparations or where oral iron preparations cannot be used as per the Investigator.
5.Patients requiring total iron of at least 750 mg based on individual assessment of iron deficiency by the Investigator.
6.Patients with a prescription for treatment with ferric carboxymaltose injections prior to randomization in the study.
7.Patients willing to adhere to the protocol requirements and to provide written informed consent.
8.Patients can understand and comply with the study procedures, in the opinion of the investigator.
9.For Female patients:
Female of childbearing potential having negative Serum ß-hCG (pregnancy test) at screening and Urine Pregnancy test at admission and practicing an acceptable method of birth control for the duration of the study as judged by the investigator s , such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence, OR
Postmenopausal for at least 01 years from the last menstrual date, OR
Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
Patients will be excluded from the study, if they meet any of the following criteria:
1.Ongoing pregnancy or lactation or nursing females.
2.Known hypersensitivity to Investigational Medicinal Product, excipients, or other parenteral iron products.
3.History of:
Anaemia not caused by iron deficiency - e.g., aplastic, megaloblastic or hemolytic anemia, sideroblastic anemia or related to acute or ongoing, hemoglobinopathies, rheumatic and other chronic diseases like CKD, autoimmune diseases, malignancies, bone marrow diseases, enzyme defects, and drug induced anemia.
Known allergies including drug allergies, including patients with a history of severe asthma, eczema or other atopic allergy.
Haemochromatosis or other iron storage or disturbances in the utilization of iron disorders or evidence of iron overload.
Clinically significant - systolic more than 160 and or diastolic more than 100 or labile hypertension Any ongoing acute or chronic infection or ongoing bacteremia at screening.
Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardize the patient’s safety or compliance with the protocol.
Alcoholism or drug abuse, or severe emotional, behavioral or psychiatric problems within 6 months before screening, who may not be able to adequately comply with the requirements of the study.
Any active malignancy within 5 years before screening.
4.Known:
Significant comorbidities like major cardiovascular disease uncontrolled endocrinological or metabolic disorders; malignancy, active renal disease, active liver disease, active peptic ulcer, asthma, or rheumatoid arthritis.
Liver dysfunctions including particular Porphyria Cutanea Tarda - PCT or elevated serum transaminases to more than three times the upper limit of normal - ULN
HIV positive or Acquired Immune Deficiency Syndrome -AIDS related illness, or HIV seropositivity at screening.
Active or chronic Hepatitis B or Hepatitis C infection, or Hepatitis B and or Hepatitis C seropositivity at screening, if not related to vaccination.
Bleeding disorders; acute bleeding or recently documented hemorrhage or recent blood loss leading to hemodynamic instability within 3 months before screening.
5.Receipt of:
Medications (Refer Annexure III) that may affect PK results within 14 days before enrolment.
Oral iron supplementation within the past 14 days before screening and prior to dosing.
Blood transfusion within 3 months before screening, or anticipated need for a blood transfusion during the study.
Parenteral iron therapy within the last 6 months before screening.
Erythropoietin/Erythroid Stimulating Agent treatment within 6 months before screening.
6.Patients who are on sodium controlled diet.
7.Donation of blood (1 unit or 350 mL) within 90 days before receiving the single dose of IMP.
8.Inadequate venous access for PK sampling as judged by the investigator.
9.Requirement of any planned procedure or hospitalization for pre-existing conditions during the study period.
10.Patients were found positive on a urine scan for drugs of abuse and/or breath test for alcohol consumption at screening and at the time of check-in and drinking more than five cups of xanthine-containing beverages per day.
11.The receipt of an investigational
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the bioequivalence of Ferric carboxymaltose solution for injection 750mg per 15 mL- 50 mg iron per mL against INJECTAFER in patients with iron deficiency anemia for whom oral supplementation alone was not adequate or is not appropriate under fasting conditions.Timepoint: A total of 31 blood samples will be collected during study. <br/ ><br>The blood samples of 05 mL each will be collected at -24.000 and <br/ ><br>-12.000 hours before initiation of IMP injection <br/ ><br>The blood samples -28 time points for PK analysis will be collected after start of infusion.
- Secondary Outcome Measures
Name Time Method To monitor the safety and tolerability profile of the study formulations.Timepoint: A total of 31 blood samples will be collected during study. <br/ ><br>The blood samples of 05 mL each will be collected at -24.000 and <br/ ><br>-12.000 hours before initiation of IMP injection <br/ ><br>The blood samples -28 time points for PK analysis will be collected after start of infusion. <br/ ><br>