Healthy volunteers.
Conditions
Interventions
Intervention 1: Intervention group: Single-dose of Ferric Carboxymaltose 500 mg Vial of the Test Drug (Darou Darman Arang, Iran) in the first period. Cross-over design with one week washing period. Af
Sponsors
Arang Pharm Co.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Adult patients with iron deficiency anemia for whom oral iron supplements alone are insufficient or inappropriate for treatment. Non-dialysis chronic kidney disease patients who have iron deficiency anemia and have been prescribed the drug ferric carboxymaltose. The inclusion criteria for these patients in the study are having the following conditions: Weight over 50 kg.
Exclusion criteria
Exclusion criteria: Pregnancy and Lactation. Patients who are allergic to this drug or a similar drug. Patients with hypertension. Any other disease state or use of medications that affect the pharmacokinetic status of the drug. Bleeding leading to hemodynamic instability. Receiving injectable iron within the past 3-6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug concentration in blood. Timepoint: 0? 0.5? 0.75? 1? 2? 4? 6? 12? 24? 36? 48, 72 hours after drug administration. Method of measurement: ICP-MS will be used to measure total iron in serum. Special kits will also be used to measure transferrin-bound iron. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach maximum blood concentration. Timepoint: After intervention. Method of measurement: The time to reach the maximum drug concentration in blood is recorded. This is done after completing the device analysis of the samples and through the WinNonLine software developed by Phoenix Company.;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