NCT06080555

Bioequivalence Study of Ferric Carboxymaltose Injection in Participants With Iron Deficiency Anaemia

A Randomized, Open-label, Parallel, Two-treatment, Single-dose Bioequivalence Study of Ferric Carboxymaltose Injection in Participants With Iron Deficiency Anaemia Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Sichuan Huiyu Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Conditions

• Iron Deficiency
• Anaemia

Interventions

Type	Name	Description
DRUG	Ferric Carboxymaltose Injection	For the T group, participants will have a standardized dinner on the night before the trial, followed by a fasting period of at least 10 h before receiving the test product (T, 10 mL: 500 mg elemental iron) via intravenous injection in the single upper limb, at a continuous rate for 5 min, with a speed of 2 mL/min.
DRUG	Ferric Carboxymaltose Injection [Ferinject]	For the R group, participants will have a standardized dinner on the night before the trial, followed by a fasting period of at least 10 h before receiving the reference product (trade name: Ferinject®) (R, 10 mL: 500 mg elemental iron) via intravenous injection on an empty stomach, at a continuous rate for 5 min, with a speed of 2 mL/min.

Timeline

• Start date: 2023-10-09
• Primary completion: 2024-01-22
• Completion: 2024-03-22
• First posted: 2023-10-12
• Last updated: 2024-04-18

Locations

4 sites across 1 country: China