Bioequivalence Study of Ferric Carboxymaltose Injection in Participants With Iron Deficiency Anaemia
Status:
Completed
Trial end date:
2024-03-22
Target enrollment:
Participant gender:
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
Phase:
Phase 1
Details
Lead Sponsor:
Sichuan Huiyu Pharmaceutical Co., Ltd
Collaborators:
Boji Data Technology (Beijing) Co., Ltd. Boji Medical Technology Co., Ltd. Suzhou Guochen Biotek Co., Ltd. The First Hospital of Jilin University