MedTrace Logo

A Study of Ferric Derisomaltose Injection in Chinese Participants With Iron Deficiency Anemia Under Fasting Conditions

NCT07790562 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2026-08-27

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 anemia under fasting condition. The main questions it aims to answer are:

* \[Question 1\] Is there significant difference in the pharmacokinetic profile between the ferric derisomaltose injection 10mL:1000mg \[calculated by iron\]) provided by Sichuan Huiyu Pharmaceutical Co., Ltd. and the ferric derisomaltose injection held by Pharmacosmos A/S . (trade name: MonoFer®, strength: 10mL:1000mg \[calculated by iron\]) )?
* \[Question 2\] Is it safe for participants with iron deficiency anemia to take ferric derisomaltose injection (10mL:1000mg \[calculated by iron\])) 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 participants with iron deficiency anemia 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)
* Pharmacokinetics(PK) blood sample collection
* Safety evaluation

Conditions

Interventions

DRUG

Ferric Derisomaltose 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,10mL:1000mg \[calculated by iron\]) via intravenous infusion, diluted to 100 mL with 0.9% sodium chloride injection, and infused continuously for 30 min (±2 min).

DRUG

Ferric Derisomaltose Injection [MonoFer®]

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: MonoFer®) (R,10mL:1000mg \[calculated by iron\]) via intravenous infusion, diluted to 100 mL with 0.9% sodium chloride injection, and infused continuously for 30 min (±2 min).

Sponsors & Collaborators

  • Suzhou Chenyan Life Science Co., Ltd.

    collaborator UNKNOWN

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

    collaborator UNKNOWN

  • Boji Medical Technology Co., Ltd.

    collaborator INDUSTRY

  • Hopeshine-Minsheng Hospital of Xinzheng

    collaborator UNKNOWN

  • Sichuan Huiyu Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-23
Primary Completion
2026-09-15
Completion
2026-11-01

Countries

  • China

Study Locations

More Related Trials

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 NCT07790562 on ClinicalTrials.gov