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Clinical Trial 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


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06080555
Study type Interventional
Source Sichuan Huiyu Pharmaceutical Co., Ltd
Contact
Status Completed
Phase Phase 1
Start date October 9, 2023
Completion date March 22, 2024

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