Skip to content

Bioequivalence study of 500 mg Ferric Carboxymaltose injection vial (Aeroject) manufactured by Actoverco

Bioequivalence study of 500 mg Ferric Carboxymaltose injection vial (Aeroject) manufactured by Actoverco in commercial brand drug

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240804062647N4
Enrollment
50
Registered
2025-05-16
Start date
2025-05-22
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

This study is conducted on healthy volunteers..

Interventions

Intervention 1: Intervention group: Intravenous injection of 2ml of ferric carboxy maltose manufactured by Vifor Pharma company, slowly over one minute, once as a reference. Intervention 2: Interven

Sponsors

?Actoverco Pharmaceutical Company
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 15 Years

Inclusion criteria

Inclusion criteria: Informed consent Age (18-55 years old) Weight over 50 kg General Health (Liver, Heart, and Kidney) Body Mass Index (18-30)

Exclusion criteria

Exclusion criteria: Pregnancy and breastfeeding History of allergy to ferric carboxy maltose or similar drugs Patients with high blood pressure Blood loss in a way that leads to hemodynamic instability. Receiving intravenous iron in the last 3-6 months.

Design outcomes

Primary

MeasureTime frame
Plasma concentration of the drug. Timepoint: Before, 0.5, 0.45, 1, 2, 4, 6, 12, 24, 36, 48 and 72h after drug administration. Method of measurement: Liquid Chromatography Mass-Mass.

Secondary

MeasureTime frame
Time to reach maximum plasma concentration. Timepoint: After intervention. Method of measurement: Time to reach the maximum drug concentration in plasma is recorded.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMassoud Amanlou

Tehran University of Medical Sciences

amanlou@tums.ac.ir+98 21 6695 9067

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026