A Randomized, Open-label, Parallel, Two-treatment, Single-dose Bioequivalence Study of Ferric Carboxymaltose Injection in Participants With Iron Deficiency Anaemia Under Fasting Conditions
Overview
- Phase
- Phase 1
- Intervention
- Ferric Carboxymaltose Injection
- Conditions
- Iron Deficiency
- Sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
- Enrollment
- 84
- Locations
- 4
- Primary Endpoint
- Pharmacokinetic parameter of total iron in serum: Cmax
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The goal of this clinical trial is to compare the pharmacokinetic profile of the developed drug product and reference product in participants with iron deficiency anaemia under fasting condition. The main questions it aims to answer are:
- [Question 1] Is there significant difference in the pharmacokinetic profile between the ferric carboxymaltose injection (10 mL: 500 mg [calculated by iron]) provided by Sichuan Huiyu Pharmaceutical Co., Ltd. and the ferric carboxymaltose injection (trade name: Ferinject®, strength: 10 mL: 500 mg [calculated by iron]) held by Vifor France?
- [Question 2] Is it safe for patient to take ferric carboxymaltose injection (10 mL: 500 mg [calculated by iron]) provided by Sichuan Huiyu Pharmaceutical Co., Ltd. under fasting condition? Participants will be randomly divided into two groups by stratified blocked randomization, with equal number of patients in each group,to receive test product or reference product according to the protocol below.
- Dosing on D1: Group T (Test product) Group R (Reference product)
- PK blood sample collection
- Safety evaluation
Investigators
Eligibility Criteria
Inclusion Criteria
- •(all inclusion criteria must be met to be included)
- •Participants with a thorough understanding of the content, process, and potential adverse reactions of the study, who have signed Informed Consent Form;
- •Those able to complete the study as per the study protocol;
- •Participants (including their partners) having no planning for pregnancy from the screening through 3 months after the last administration, and willing to take effective contraceptive measures;
- •Male and/or female participants aged 18-60 (including those aged 18 and 60);
- •Male participants weighing not less than 50 kilograms and female participants weighing not less than 45 kilograms. Body mass index (BMI) = weight (kg)/height 2 (m2), with a body mass index ranging from 18 to 30 kg/m2 (including both boundaries);
- •Diagnosis of iron-deficiency anemia is confirmed during the screening process based on the following criteria (both criteria must be met): ①Hemoglobin (Hb) \< 110 g/L (for females) or Hb \< 120 g/L (for males). ②Serum ferritin ≤ 100 ng/mL, or when the serum transferrin saturation (TSAT) is ≤ 30%, serum ferritin ≤ 300 ng/mL.
Exclusion Criteria
- •(meeting any one of these criteria will result in exclusion)
- •Participants with an allergic constitution, such as asthma and eczema, or having known hypersensitivity to iron, maltose or its analogues, metabolites;
- •In addition to iron-deficiency anemia, participants will be excluded from the screening process if they have had any of the following conditions within the past 6 months: cardiovascular, digestive, respiratory, urinary, hematological, metabolic, immune, or neurological system diseases, or any active malignancies as determined by the investigator;
- •Individuals with acute infection in previous 2 weeks prior to the screening visit;
- •laboratory tests: alanine aminotransferase (ALT) \> 1.5 times the upper limit of the normal range (× ULN); aspartate transaminase (AST) \> 1.5 × ULN; total serum bilirubin (TBiL) \> 1.5 × ULN; albumin \< 30 g/L; platelet count \< 90 × 109/L; neutrophil absolute count \< 1.3 × 109/L; glomerular filtration rate \< 60 mL/min/1.73 m2 (estimated based on simplified Modification of Diet in Renal Disease (MDRD) formula);
- •Serious arrhythmias showed in ECG at screening period, such as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation accompanied by rapid ventricular response or supraventricular tachycardia, and are not suitable for the trial at the investigator's discretion;
- •With history of iron storage diseases such as haemochromatosis; history of iron utilisation disorders such as sideroachrestic anaemia; history of haemoglobinopathy (such as Thalassemia); having symptomatic anemia requiring red blood cell infusion;
- •Receiving IV iron therapy in previous 3 months prior to the screening visit, erythropoiesis stimulating agent (ESA) therapy and/or blood transfusion in previous 4 weeks prior to the screening visit, and oral iron or iron-containing products in previous 7 days prior to the screening visit;
- •Receiving any prescription drugs that affect PK results in previous 14 days prior to the screening visit;
- •Receiving any non-prescription drugs, traditional Chinese medicine, or healthcare products that affect PK results in previous 7 days prior to the screening visit;
Arms & Interventions
Test product-Ferric carboxymaltose Injection provided by SichuanHuiyuPharma
Intervention: Ferric Carboxymaltose Injection
Reference product-marketed by Vifor France
Intervention: Ferric Carboxymaltose Injection [Ferinject]
Outcomes
Primary Outcomes
Pharmacokinetic parameter of total iron in serum: Cmax
Time Frame: 24hours,12hours,0hour before administration, and 5minutes,10minutes,15minutes,30minutes,45minutes,1hour,1.5hours,2hours,4hours,6hours,8hours,10hours,12hours,24hours,36hours,48hours,72hours,96hours,120hours and 144hours after administration.
Cmax is the peak concentration of total iron in serum. It is directly obtained from observed blood drug concentration-time data.
Pharmacokinetic parameter of total iron in serum: AUC0-t
Time Frame: 24hours,12hours,0hour before administration, and 5minutes,10minutes,15minutes,30minutes,45minutes,1hour,1.5hours,2hours,4hours,6hours,8hours,10hours,12hours,24hours,36hours,48hours,72hours,96hours,120hours and 144hours after administration.
AUC0-t is the area under the concentration curve from dosing to the last measurable blood drug concentration.It is calculated using the linear trapezoidal rule.
Pharmacokinetic parameter of transferrin bound iron in serum: Cmax
Time Frame: 24hours,12hours,0hour before administration, and 5minutes,10minutes,15minutes,30minutes,45minutes,1hour,1.5hours,2hours,4hours,6hours,8hours,10hours,12hours,24hours,36hours,48hours,72hours,96hours,120hours and 144hours after administration.
Cmax is the peak concentration of transferrin bound iron in serum. It is directly obtained from observed blood drug concentration-time data.
Pharmacokinetic parameter of transferrin bound iron in serum: AUC0-t
Time Frame: 24hours,12hours,0hour before administration, and 5minutes,10minutes,15minutes,30minutes,45minutes,1hour,1.5hours,2hours,4hours,6hours,8hours,10hours,12hours,24hours,36hours,48hours,72hours,96hours,120hours and 144hours after administration.
AUC0-t is the area under the concentration curve from dosing to the last measurable blood drug concentration.It is calculated using the linear trapezoidal rule.
Secondary Outcomes
- Pharmacokinetic parameter of total iron in serum:λz(24hours,12hours,0hour before administration, and 5minutes,10minutes,15minutes,30minutes,45minutes,1hour,1.5hours,2hours,4hours,6hours,8hours,10hours,12hours,24hours,36hours,48hours,72hours,96hours,120hours and 144hours after administration.)
- Pharmacokinetic parameter of total iron in serum: AUC0-∞(24hours,12hours,0hour before administration, and 5minutes,10minutes,15minutes,30minutes,45minutes,1hour,1.5hours,2hours,4hours,6hours,8hours,10hours,12hours,24hours,36hours,48hours,72hours,96hours,120hours and 144hours after administration.)
- Pharmacokinetic parameter of total iron in serum: Tmax(24hours,12hours,0hour before administration, and 5minutes,10minutes,15minutes,30minutes,45minutes,1hour,1.5hours,2hours,4hours,6hours,8hours,10hours,12hours,24hours,36hours,48hours,72hours,96hours,120hours and 144hours after administration.)
- Pharmacokinetic parameter of total iron in serum: t1/2(24hours,12hours,0hour before administration, and 5minutes,10minutes,15minutes,30minutes,45minutes,1hour,1.5hours,2hours,4hours,6hours,8hours,10hours,12hours,24hours,36hours,48hours,72hours,96hours,120hours and 144hours after administration.)
- Pharmacokinetic parameter of transferrin bound iron in serum: AUC0-∞(24hours,12hours,0hour before administration, and 5minutes,10minutes,15minutes,30minutes,45minutes,1hour,1.5hours,2hours,4hours,6hours,8hours,10hours,12hours,24hours,36hours,48hours,72hours,96hours,120hours and 144hours after administration.)
- Pharmacokinetic parameter of transferrin bound iron in serum: Tmax(24hours,12hours,0hour before administration, and 5minutes,10minutes,15minutes,30minutes,45minutes,1hour,1.5hours,2hours,4hours,6hours,8hours,10hours,12hours,24hours,36hours,48hours,72hours,96hours,120hours and 144hours after administration.)
- Pharmacokinetic parameter of transferrin bound iron in serum: t1/2(24hours,12hours,0hour before administration, and 5minutes,10minutes,15minutes,30minutes,45minutes,1hour,1.5hours,2hours,4hours,6hours,8hours,10hours,12hours,24hours,36hours,48hours,72hours,96hours,120hours and 144hours after administration.)
- Pharmacokinetic parameter of transferrin bound iron in serum:λz(24hours,12hours,0hour before administration, and 5minutes,10minutes,15minutes,30minutes,45minutes,1hour,1.5hours,2hours,4hours,6hours,8hours,10hours,12hours,24hours,36hours,48hours,72hours,96hours,120hours and 144hours after administration.)