Iron Deficiency Clinical Trial
Official title:
A Randomized, Open-label, Parallel, Two-treatment, Single-dose Bioequivalence Study of Ferric Carboxymaltose Injection in Participants With Iron Deficiency Anaemia Under Fasting Conditions
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
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01483768 -
Study of Sleeve Gastrectomy on Iron Intestinal Absorption in Morbidly Obese Patients
|
N/A | |
| Completed |
NCT02888171 -
Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency
|
N/A | |
| Recruiting |
NCT02242188 -
Supplementing Iron and Development in Breastfed Infants (SIDBI Study)
|
Phase 4 | |
| Completed |
NCT02714361 -
A Study to Investigate the Effect of Vitamin D3 Supplementation on Iron Status in Iron Deficient Women
|
N/A | |
| Completed |
NCT02176759 -
Iron Absorption From Rice Fortified With Ferric Pyrophosphate
|
N/A | |
| Completed |
NCT01991626 -
Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From LNS Added to Complementary Foods
|
N/A | |
| Completed |
NCT01922479 -
Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure
|
Phase 4 | |
| Completed |
NCT01687062 -
Iron Absorption From Tef-injera in Women of Reproductive Age
|
N/A | |
| Completed |
NCT01573013 -
Iron Fortification Trail Using NaFeEDTA in Iron Deficient Lead-exposed Children
|
N/A | |
| Completed |
NCT01191463 -
The Efficacy of a Local Vitamin-C Rich Fruit (Guava) in Improving Iron Absorption From Mungbean Based Meals and Its Effect on Iron Status of Rural Indian Children (6-10 Years)
|
N/A | |
| Completed |
NCT01443832 -
Iron Absorption From Iron-fortified Fonio Porridge: a Stable Isotope Study
|
Phase 0 | |
| Completed |
NCT01061307 -
An Efficacy Trial of Iron, Zinc and Vitamin A Fortified Rice in Children in Satun, Thailand
|
Phase 0 | |
| Not yet recruiting |
NCT00515918 -
The Effect of Early Iron Deficiency on Developmental Brain and Behavior in Infants
|
N/A | |
| Recruiting |
NCT00378469 -
Study of the Effects of Muscular Activity on Iron Metabolism
|
N/A | |
| Recruiting |
NCT05992116 -
Iron Deficiency in Patients With Heart Failure and Reduced and Mildly Reduced Ejection Fraction
|
||
| Completed |
NCT05262634 -
Pregnancy Outcome in Women With an Iron Deficiency in the First Trimester
|
||
| Completed |
NCT04602247 -
Evaluation of Iron Bioavailability From Iron Chlorophyllin
|
N/A | |
| Completed |
NCT02996786 -
Effects of Danggui Buxue Tang on Blood Biochemical Parameters in Male Recreational Runners
|
N/A | |
| Completed |
NCT02175888 -
The Optimization of Bioavailability From Iron Supplements: Study 1
|
N/A | |
| Completed |
NCT02308449 -
Iron Status and Human Metabolism
|
N/A |