84
Participants
Start Date
October 9, 2023
Primary Completion Date
January 22, 2024
Study Completion Date
March 22, 2024
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.
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.
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
Collaborators (1)
The First Hospital of Jilin University
OTHER
Suzhou Guochen Biotek Co., Ltd.
UNKNOWN
Boji Data Technology (Beijing) Co., Ltd.
UNKNOWN
Boji Medical Technology Co., Ltd.
UNKNOWN
Sichuan Huiyu Pharmaceutical Co., Ltd
INDUSTRY