Multicenter randomized single dose parallel open label bioequivalence
- Conditions
- Health Condition 1: D598- Other acquired hemolytic anemias
- Registration Number
- CTRI/2022/11/047535
- Lead Sponsor
- Emcure Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients diagnosed with iron deficiency anemia, for whom oral supplementation alone is not adequate/appropriate.
2.Iron status evaluation (Total Iron Binding capacity, Serum Iron <= 10 mmol, % Transferrin Saturation, Serum Ferritin <= 100ng/mL or <=300ng/mL when TSAT is <=30%. Observed values for Total Iron Binding Capacity, %Transferrin Saturation and Serum Ferritin are to be consistent with a primary diagnosis of iron deficiency anemia.
3.Age, race, & ethnicity: Adults between the ages of 18 and 65 years. Patient must meet age requirements at the time of signing the initial informed consent and at the time of study drug administration. In addition, the patientâ??s race (e.g. Caucasian, Black, Asian, etc) and ethnicity (i.e. Hispanic, Non-Hispanic) should be documented.
4.Sex: Males and/or non-pregnant, non-lactating females.
a.Women of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days prior to the initial dose of study medication.
b.Women taking hormone replacement therapy or receiving a hormonal contraceptive will be eligible to participate as long as they have been on a stable regimen for at least 3 months prior to receiving the study medication and plan to remain on the same regimen for the duration of this study or women using an intrauterine device for at least 3 months prior to receiving the study medication.
c.Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
i.Postmenopausal with spontaneous amenorrhea for at least one (1) year, or spontaneous amenorrhea for less than one (1) year with serum FSH levels >40mIU/ml, or
ii.Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
iii.Total hysterectomy and an absence of bleeding for at least 3 months.
5.Weight: Each patient is required to weigh at least 50 kg.
6.Body Mass Index (BMI) should be between 18.5 kg/m2 - 30.0 kg/m2. (both inclusive)
7.Smoking Status: Non-smokers preferred, however, up to moderate smokers (up to 10 cigarettes and biddies or equivalent per day with results included in the study database (if applicable), and Patientâ??s CRF.
8.Adequate venous access in both arms for the collection of a number of blood samples during the study.
9.Able to understand & give written informed consent. Utilization of only literate patients are permitted
10.Willing to follow the protocol requirements and comply with protocol restrictions.
1.Hospitalised patients i.e. the patients who are currently hospitalised.
2.Social Habits:
a)Ingestion of any alcoholic beverage within the 48.00 hours prior to the initial administration of study medication.
b)Ingestion of any caffeine- or xanthine-containing food or beverage within the 24.00 hours prior to the initial administration of study medication.
c)Ingestion of any vitamins or herbal products within 7 days prior to the initial administration of the study medication.
d)Any recent, significant change in dietary or exercise habits.
e)History of drug and/or alcohol abuse within one year of randomization.
f)Use of any nicotine containing product during any in-house study period.
3.Medications:
a)Parenteral iron therapy within 6 months prior to the initial dose of study medication.
b)Oral iron therapy within 14 days prior to randomization.
c)Erythropoiesis stimulating agents within 3 months prior to the initial dose of study medication.
d)Patients receiving concomitant medications (e.g. iron chelating agents such as deferoxamine, deferasirox, deferiprone, deferitazole, zinc picolinate, chromium picolinate etc.) that affect the pharmacokinetics of iron may be excluded following consultation with a pharmacokinetic team.
4.Patients with hemochromatosis or other iron storage disorders.
5.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.
6.Patients who received a whole blood transfusion or red blood cell transfusion within 90 days prior to the administration of study medication.
7.Any reason which, in the opinion of the Principal Investigator or Medical Sub-Investigator, would prevent the patient from safely participating in the study.
8.Intolerance to venipuncture
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the bioequivalence of Ferric Carboxymaltose Injection 50 mg/ml (750mg/15ml) of Emcure Pharmaceutical Limited with INJECTAFER® (ferric carboxymaltose injection) of American Reagent, Inc., 750 mg iron/15ml, to adult patients with iron deficiency anemia. <br/ ><br>Timepoint: Screening <br/ ><br>(-28 days)Day (-2) (Check in -36.00 hours)Day (-1) (-24.00 hours)Days 1 to Day 4 (In house treatment period)Day 4 (Check-out 168.00 hours)End of Study/ Safety follow-up visit <br/ ><br>
- Secondary Outcome Measures
Name Time Method To assess the safety and tolerability of Emcureâ??s Ferric Carboxymaltose Injection 50 mg/ml (750mg/15ml) with INJECTAFER® (ferric carboxymaltose injection), 750 mg iron/15ml based upon reported adverse events, clinical laboratory results, clinical investigations, and vital signs. <br/ ><br> <br/ ><br>Timepoint: Screening <br/ ><br>(-28 days)Day (-2) (Check in -36.00 hours)Day (-1) (-24.00 hours)Days 1 to Day 4 (In house treatment period)Day 4 (Check-out 168.00 hours)End of Study/ Safety follow-up visit <br/ ><br>