Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-30 @ 9:34 AM
Study NCT ID:
NCT06895993
Status:
COMPLETED
Last Update Posted:
2025-05-18
First Post:
2025-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants
Sponsor:
Sichuan Huiyu Pharmaceutical Co., Ltd
Organization:
Study Overview
Official Title:
A Randomized, Open-label, Parallel, Two-treatment, Single Dose Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants Under Fasting Conditions
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 (100 mg iron/2 mL) provided by Sichuan Huiyu Pharmaceutical Co., Ltd. and the ferric carboxymaltose injection licensed by American Regent, Inc. (trade name: Injectafer®, strength: 100 mg iron/2 mL)?
* \[Question 2\] Is it safe for healthy participants 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 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
* \[Question 1\] Is there significant difference in the pharmacokinetic profile between the ferric carboxymaltose injection (100 mg iron/2 mL) provided by Sichuan Huiyu Pharmaceutical Co., Ltd. and the ferric carboxymaltose injection licensed by American Regent, Inc. (trade name: Injectafer®, strength: 100 mg iron/2 mL)?
* \[Question 2\] Is it safe for healthy participants 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 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: