A multicenter, open label, balanced, randomized, single-dose, two-treatment, single period, parallel bioequivalence study of Ferric carboxymaltose solution for injection 750mg per 15 mL -50 mg iron per mL of DifGen Pharmaceuticals LLC, with that of INJECTAFER Ferric carboxymaltose solution for injection 750mg per 15 mL - 50 mg iron per mL ] of American Regent, Inc. - USA in patients with iron deficiency anemia under fasting condition.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 5
- 主要终点
- 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.
研究概览
简要总结
The Study consist of single period, patient will receive either test / reference [ferric carboxymaltose solution for injection/infusion (50 mg iron/mL)] as per randomization schedule on dosing day,
A total of 31 blood samples will be collected during study.
The blood samples (03-time points including pre-injection blood sample) of 05 mL each will be collected at -24.000 and -12.000 hours before initiation of IMP injection with an allowable deviation of ±5 minutes and 0.000 hours within -5 minutes before initiation of IMP undiluted as a slow intravenous injection.
The blood samples (28-time points) of 05 mL each (except *04 mL for the marked time points) for PK analysis will be collected at 0.083 (5 min), 0.133 (8 min) 0.250 (15 min) 0.500 (30 min), 0.750 (45 min), 1.000, 1.250, 1.500, 1.750, 2.000, 3.000, 4.000, 6.000, 8.000, 10.000, 12.000, 16.000, 24.000, 36.000, 48.000, 60.000, 72.000, 96.000 (Day 5), 120.000 (Day 6), 144.000 (Day 7), 168.000 (Day 8), 216.000* (Day 10) and 264.000* (Day 12) hours after start of infusion.
Note: 04 mL blood will be collected to following time points: 216.000 (Day 10) and 264.000 (Day 12) hours after start of infusion.
Note: A deviation of ±1 minutes will be allowed for post-dose samples up to 1.000 hrs. and a deviation of ±2 minutes will be allowed for post-dose samples up to 72.000 hrs. The ambulatory samples scheduled at and after 96.000 hrs. will be collected with an allowable deviation of ±2 hrs.
Different arms will be used for injection and blood withdrawal (of PK samples). Baseline samples (-24.000, -12.000) hours will be collected via fresh vein puncture. Samples from 0.000 to 24.000 hrs. will be collected from an indwelling cannula placed in a forearm vein. If required, it may also be collected through a fresh vein puncture. The heparin-lock technique will be used to prevent the clotting of blood in the indwelling cannula. Before each blood sample is drawn via the indwelling cannula, 0.5 mL of blood will be discarded to prevent the saline-diluted blood and heparin from interfering with the analysis. Blood samples after 24 hours will be collected through a fresh vein puncture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female patients with age 18-65 years -inclusive of both
- •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.
- •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.
- •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.
- •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.
- •Patients requiring total iron of at least 750 mg based on individual assessment of iron deficiency by the Investigator.
- •Patients with a prescription for treatment with ferric carboxymaltose injections prior to randomization in the study.
- •Patients willing to adhere to the protocol requirements and to provide written informed consent.
- •For Female patients: Female of childbearing potential having negative Serum β-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).
排除标准
- •Patients will be excluded from the study, if they meet any of the following criteria:
- •Ongoing pregnancy or lactation or nursing females.
- •Known hypersensitivity to Investigational Medicinal Product, excipients, or other parenteral iron products.
- •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.
- •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.
- •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.
- •Patients who are on sodium controlled diet.
- •Donation of blood (1 unit or 350 mL) within 90 days before receiving the single dose of IMP.
- •Inadequate venous access for PK sampling as judged by the investigator.
- •Requirement of any planned procedure or hospitalization for pre-existing conditions during the study period.
- •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.
- •The receipt of an investigational medicinal product or participation in other drug research study within a period of 30 days (or 5 half-lives, whichever is longer) before the first dose of an investigational medicinal product for the current study. Note: The elimination half-life of the study drug should be taken into consideration for the inclusion of the patient in the study.
- •Abnormal baseline laboratory/physical findings are considered to be clinically significant by the investigator.
- •Patients with any significant history of non-compliance or inability to reliably grant informed consent.
结局指标
主要结局
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.
时间窗: A total of 31 blood samples will be collected during study. | The blood samples of 05 mL each will be collected at -24.000 and | -12.000 hours before initiation of IMP injection | The blood samples -28 time points for PK analysis will be collected after start of infusion.
次要结局
- To monitor the safety and tolerability profile of the study formulations.(A total of 31 blood samples will be collected during study.)
研究者
Dr Rakesh Patel
Veeda Clinical Research Limited