This study is conducted on healthy volunteers..
Conditions
Interventions
Intervention 1: Intervention group 1: injection solution of ferric carboxy maltose 50 mg/ml manufactured by Vifor Pharma company as a reference. Intervention 2: Intervention group 2: injection solutio
Sponsors
Zistdaru danesh Co.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Weight over 50 kg Informed consent Age (18-55 years old)
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
| Measure | Time 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
| Measure | Time 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 ContactJavad Shokri
Tabriz University of Medical Sciences
Outcome results
None listed