Bioequivalence Study of Iron Sucrose Injection in Healthy Participants

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

November 22, 2024

Primary Completion Date

December 18, 2024

Study Completion Date

March 14, 2025

Conditions
BioequivalencySafety Issues
Interventions
DRUG

Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd) and Iron Sucrose injection (Reference product, Venofer)

For the Group I, participants will receive a single intravenous injection of the Test Product (Iron sucrose injection, 100 mg iron/5 mL, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd). After a washout period, subjects will receive a single intravenous injection of the Reference Product (Iron sucrose injection, Venofer®, 100 mg iron/5 mL, held by Vifor France).

DRUG

Iron Sucrose injection (Reference product, Venofer) and Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd)

For the Group II, participants will receive a single intravenous injection of the Reference Product (Iron sucrose injection, Venofer®, 100 mg iron/5 mL, held by Vifor France) . After a washout period, subjects will receive a single intravenous injection of the Test Product (Iron sucrose injection, 100 mg iron/5 mL, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd).

Trial Locations (1)

Unknown

Henan (Zhengzhou) Zhonghui Cardiovascular Hospital, Zhengzhou

All Listed Sponsors
collaborator

Henan (Zhengzhou) Zhonghui Cardiovascular Hospital

UNKNOWN

collaborator

Changsha Duxact Biotechnology Co., Ltd

UNKNOWN

collaborator

Suzhou Guochen Biotechnology Co., Ltd.

UNKNOWN

lead

Sichuan Huiyu Pharmaceutical Co., Ltd

INDUSTRY

NCT06674486 - Bioequivalence Study of Iron Sucrose Injection in Healthy Participants | Biotech Hunter | Biotech Hunter