84
Participants
Start Date
April 7, 2025
Primary Completion Date
May 8, 2025
Study Completion Date
May 8, 2025
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, 2 mL: 100 mg elemental iron) via intravenous injection in the single upper limb, at a continuous rate for 1 min, with a speed of 2 mL/min.
Ferric Carboxymaltose Injection [Injectafer®]
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: Injectafer®) (R, 2 mL: 100 mg elemental iron) via intravenous injection on an empty stomach, at a continuous rate for 1 min, with a speed of 2 mL/min.
Phase I clinical trial unit of the First Hospital of Jilin University, Changchun
Collaborators (1)
Suzhou Guochen Biotechnology Co., Ltd.
UNKNOWN
Guangzhou Jeeyor Medical Research Co.,Ltd.
UNKNOWN
Boji Medical Technology Co., Ltd.
UNKNOWN
The First Hospital of Jilin University
OTHER
Sichuan Huiyu Pharmaceutical Co., Ltd
INDUSTRY