Bioequivalence study of Ferric carboxymaltose solution in patients with irondeficiency anemia, for whom oral iron preparations are ineffective or cannot beused, under fasting condition.

Not Applicable

• Conditions: Health Condition 1: D50- Iron deficiency anemia

• Registration Number: CTRI/2021/08/035672
• Lead Sponsor: Dr Reddys Laboratories Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Male and female subjects with age 18 to 65 inclusive of both years.

2. Subjects weight within clinically acceptable normal range according to normal values for Body Mass Index 18.50 to 24.90 kg per m2 both inclusive with minimum of 50 kg body weight.

3. Subjects diagnosed with Iron Deficiency Anemia based on laboratory tests. For whom oral iron preparations are ineffective or cannot be used. Require total iron of at least 1000 mg based on individual assessment of iron deficiency are eligible for enrolment.

4. Hemoglobin value more than 7 and less than 14 gm per dL at screening.

5. Ferritin less than or equal to 100 ng per mL or less than or equal to 300 ng per mL when TSAT is less than or equal 30 percent at screening.

6. Subjects willing to adhere to the protocol requirements and to provide written informed consent.

7. Subjects able to understand and comply with the study procedures, in the opinion of the investigator

8. For Female Subjects: Having negative Serum beta HCG pregnancy test at screening and Urine Pregnancy test at admission. AND Female of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigators, such as condoms, foams, jellies, diaphragm, intrauterine device, or abstinence, OR Postmenopausal for at least 01 year from the last menstrual date, OR Surgically sterile bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject.It is investigators responsibility to ensure that above points regarding an effective method of avoiding pregnancy are discussed with patient or legally acceptable representative in detail and patient agreed for this and it is documented in source document.The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol. LAR is an individual or juridical or other body authorised under applicable law to represent the interests of an individual, including providing consent on behalf of a prospective patient to the patients participation in the clinical trial.

Exclusion Criteria

1. Ongoing pregnancy or lactation.

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 haemolytic anaemia, sideroblastic anaemia) or related to acute or ongoing, haemoglobinopathies, rheumatic and other chronic diseases like CKD, autoimmune diseases, malignancies, bone marrow diseases, enzyme defects and drug induced anaemia. 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 utilisation 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

Patientââ?¬•s safety or compliance with the protocol.

Alcoholism or drug abuse, or severe emotional, behavioural or psychiatric problems within 6 months prior to screening, who may not be able to adequately comply with the requirements of the study. Any active malignancy within 5 years prior to 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 Immunodeficiency 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 haemorrhage or recent blood loss leading to hemodynamic instability within 3 months prior to screening.

5.Receipt of:

�Medications that may affect PK results within 14 days before enrolment.

�Oral iron supplementation within the past 14 days prior to screening.

�Blood transfusion within 3 months prior to screening, or anticipated need for a blood transfusion during the study.

�Parenteral iron therapy within the last 3 months prior to screening.

�Erythropoietin/Erythroid Stimulating Agent treatment within 6 months prior to screening.

6.Subjects who are on sodium controlled diet.

7.Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose of IMP.

8.Inadequate venous access for PK sampling as judged by investigator.

9.Requirement of any planned procedure or hospitalization for pre-existing conditions during the study period.

10.Patients found positive on urine scan for drugs of abuse and/or breath test for alcohol consumption at screening and baseline and drinking more than five cups of xanthine-containing beverages per day.

11.The receipt of an investigational medicinal product or participation in other drug research study within a period of

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the bioequivalence of Test product (Ferric carboxymaltose solution for injection/infusion <br/ ><br>(50mg iron/ml)) of Dr. Reddys Laboratories Ltd, India comparing with that of reference product, <br/ ><br>Ferinject�® [Ferric carboxymaltose injection (50 mg iron/ml)] solution for injection/infusion of Vifor Pharma UK Limited, TW18 3BA, UK in patients with iron deficiency anemia for whom oral iron <br/ ><br>preparations are ineffective or cannot be used under fasting conditions.Timepoint: The blood sample will be collected on Day 5, day 6 & Day 8

Secondary Outcome Measures

Name	Time	Method
To monitor the safety and tolerability profile of the study formulations.Timepoint: Physical examination & vital signs on Screening Day 1,2,3,4,5,6 & day 8, ECG on screening & at end of study, laboratory <br/ ><br>evaluations at screening & at end of study and adverse event monitoring from the time of first study drug administration till end of study safety <br/ ><br>assessments.