Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants

PHASE1CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

April 7, 2025

Primary Completion Date

May 8, 2025

Study Completion Date

May 8, 2025

Conditions
Healthy Adult
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, 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.

DRUG

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.

Trial Locations (1)

130000

Phase I clinical trial unit of the First Hospital of Jilin University, Changchun

Sponsors
All Listed Sponsors
collaborator

Suzhou Guochen Biotechnology Co., Ltd.

UNKNOWN

collaborator

Guangzhou Jeeyor Medical Research Co.,Ltd.

UNKNOWN

collaborator

Boji Medical Technology Co., Ltd.

UNKNOWN

collaborator

The First Hospital of Jilin University

OTHER

lead

Sichuan Huiyu Pharmaceutical Co., Ltd

INDUSTRY

NCT06895993 - Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants | Biotech Hunter | Biotech Hunter