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

NCT06080555 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-04-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • The First Hospital of Jilin University

    collaborator OTHER

  • Suzhou Guochen Biotek Co., Ltd.

    collaborator UNKNOWN

  • Boji Data Technology (Beijing) Co., Ltd.

    collaborator UNKNOWN

  • Boji Medical Technology Co., Ltd.

    collaborator UNKNOWN

  • Sichuan Huiyu Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Li Xiang · Sichuan Huiyu Pharmaceutical Co., Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-09
Primary Completion
2024-01-22
Completion
2024-03-22

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06080555 on ClinicalTrials.gov