Clinical Trial

Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants Under Fasting Conditions

Recruiting Phase 1
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Summary
The goal of this clinical trial is to compare the pharmacokinetic profile of the developed drug product and reference product in healthy participants 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 750 mg iron/15 mL provided by Sichuan Huiyu Pharmaceutical Co., Ltd. and the ferric carboxymaltose injection licensed by American Regent, Inc. (trade name: Injectafer®, strength:750 mg iron/15 mL )? * \[Question 2\] Is it safe for healthy participants to take ferric carboxymaltose injection (750 mg iron/15 mL \[calculated by iron\]) 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 healthy participants 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
Trial Details
NCT Number NCT07606105
Lead Sponsor Sichuan Huiyu Pharmaceutical Co., Ltd
Collaborators: Suzhou Guochen Biotechnology Co., Ltd., Guangzhou Jeeyor Medical Research Co.,Ltd., Boji Medical Technology Co., Ltd., Jinan Central Hospital
Conditions Healthy Adult
Enrollment 70 participants
Start Date 2026-05-19
Primary Completion 2026-08-26 (estimated)
Study Completion 2027-01-26 (estimated)
Updated on ClinicalTrials.gov 2026-05-26