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

PHASE1CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

October 9, 2023

Primary Completion Date

January 22, 2024

Study Completion Date

March 22, 2024

Conditions
Iron DeficiencyAnaemia
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.

Trial Locations (4)

Unknown

Boji medical technology (Beijing) co., Ltd, Beijing

Boji Medical Technology Co., Ltd, Guangzhou

Suzhou Guochen Biotek Co., Ltd, Suzhou

Phase I Clinical Trial Department, The First Hospital of Jilin University, Changchun

Sponsors
All Listed Sponsors
collaborator

The First Hospital of Jilin University

OTHER

collaborator

Suzhou Guochen Biotek Co., Ltd.

UNKNOWN

collaborator

Boji Data Technology (Beijing) Co., Ltd.

UNKNOWN

collaborator

Boji Medical Technology Co., Ltd.

UNKNOWN

lead

Sichuan Huiyu Pharmaceutical Co., Ltd

INDUSTRY