Investigating bioequivalence of IV solution of Ferric carboxy maltose

In vivo fasted-state bioequivalence study of Iron carboxy maltose 100mg/5ml injection manufactured by Zist Arvand Pharmed Pharmaceutical Co. compared to innovator product

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210519051345N103

Enrollment

Registered

2026-05-19

Start date

2026-06-05

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

In the present study, the products will be administered to healthy volunteers..

Interventions

Intervention 1: Intervention group: Intervention group will receive a single 500 mg dose of test product (Ferric carboxy maltose IV solution manufactured by Zist Arvand Co.) in fasted state. Blood sam

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General Health (in terms of Liver, Heart and Kidney) Age between 18-55 years

Exclusion criteria

Exclusion criteria: Smoking Pregnancy Alcohol and drug addiction History of drug allergy

Design outcomes

Primary

Measure	Time frame
Plasma concentration of drug. Timepoint: Immediately before drug administration and 0.5-72 hours in predetermined time intervals after drug administration (0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24, 48, 72 hours). Method of measurement: HPLC (High performance liquid chromatography).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParvin Zakeri-Milani

Tabriz University of Medical Sciences

pzakeri@tbzmed.ac.ir+98 41 3334 8801

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026