Bioequivalence study of Mylanâ??s Ferric Carboxymaltose Injection 750mg/15mL (50mg/mL) with American Regent INCâ??s INJECTAFER® (Ferric Carboxymaltose Injection 750mg/15mL [50mg/mL]) in adult male and female patients with iron deficiency anemia.
- Conditions
- Health Condition 1: N189- Chronic kidney disease, unspecifiedHealth Condition 2: D509- Iron deficiency anemia, unspecified
- Registration Number
- CTRI/2018/09/015767
- Lead Sponsor
- Mylan Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 238
1.Men or non-pregnant, non-lactating females aged 18-65 years (both inclusive)
2.Patients diagnosed with iron deficiency anemia, for whom oral supplementation alone is not adequate/not appropriate or with non-dialysis dependent chronic renal disease.
3.Patients considered to be suitable for treatment with Ferric Carboxymaltose Inj. based on Investigator judgement.
4.Patients with body weight >= 50 kg at screening and check in, with BMI of 18.5 â?? 30.0 kg/m2 at the time of screening.
5.Patients with Iron status at screening defined as:
ohemoglobin of >= 9.0 g/dL and < 12g/dL at screening
oFerritin levels of <= 100 ng/mL (or <= 300ng/mL when TSAT is <=30%)
6.Patients with adequate hematopoeitic and liver function at screening
7.Female patients should have been postmenopausal for at least 1 year, or surgically sterilized via hysterectomy, bilateral oophorectomy; or practicing an acceptable form of birth control 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.
8.Patient or LAR willing to provide written informed consent to participate. Patient agrees to comply with the study procedures and requirements of the study.
1.Patients with known hypersensitivity to ferric carboxymaltose, excipients, or similar product or any other iron preparation.
2.Patients who have received any of the following medications in recent past:
a.Parenteral iron therapy
b.Oral iron therapy
c.Erythropoiesis stimulating agents
d.Concomitant medications that may affect the PK results based on investigators discretion.
3.Patients with clinically significant or labile hypertension.
4.Patients with Stage 5 Chronic Kidney Disease (CKD)
5.Patients considered to be anemic due to other aetiology..
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 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.
12.Patients with positive alcohol breath test on the day of check-in.
13.Patients who participated in another clinical trial within 60 days prior to randomization.
14.Patients with known active malignancy
15.Patients with significant comorbidities that in the investigatorâ??s judgement, might increase the risk to the patient or decrease the chance of obtaining satisfactory PK data.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare and evaluate the single <br/ ><br>dose, comparative bioavailability of Ferric Carboxymaltose Injection 750mg/15mL (50mg/mL). <br/ ><br>Timepoint: Within 1 hr prior to dosing, 5.00 mins (after start of slow IV injection), 7.5 mins (after start of slow IV injection). At 20.00 mins, 40.00 mins, 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 18.00, 24.00, 30.00, 36.00, 48.00 and 72.00 hours (after start of slow IV injection)
- Secondary Outcome Measures
Name Time Method Safety and tolerability as assessed by reported adverse events, laboratory and clinical investigationsTimepoint: Vitals at Screening, Day -2 (check in), day0 to 3 Adverse events from screening to end of study <br/ ><br>Laboratory tests at Screening and end of study Day 3 <br/ ><br> <br/ ><br>