Protocol summary
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Study aim
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Bioequivalence study of the intravenous solution of Ferric carboxy maltose 50mg/ml (Ferririse)manufactured by Zistdaru Danesh versus originator brand (Ferinject) in healthy volunteers in the fasted condition
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Design
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Bioequivalence study with 2 intervention groups, Parallel, single-blinded, Two groups of 25 healthy volunteers. The rand function of Excel software was used for randomization.
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Settings and conduct
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The study is single-blinded, parallel, fasted, and on two series of healthy volunteers. The study will be done in one period (72h). The candidates are divided into two groups. the first group receives a test product and the second group receives a brand product. Blood samples are collected immediately before and after drug administration by volunteers. Then, drug extraction is done and samples are ready for analysis. These steps are performed in Radin Laboratory in Tabriz.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: Weight over 50 kg, Informed consent, Age (18-55 years old)
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.
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Intervention groups
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Intervention group 1: injection solution of ferric carboxy maltose 50 mg/ml manufactured by Vifor Pharma company as a reference
Intervention group 2: injection solution of ferric carboxy maltose 50 mg/ml manufactured by Zistdaru Danesh company as a test.
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Main outcome variables
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Maximum drug concentration, Time to reach maximum concentration, Half-life of drug
General information
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Reason for update
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The FDA proposed protocol update at the end of 2024 for this study, which would allow for the study to be conducted in healthy volunteers at a low dose.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200105046010N127
Registration date:
2025-01-05, 1403/10/16
Registration timing:
registered_while_recruiting
Last update:
2025-05-09, 1404/02/19
Update count:
1
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Registration date
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2025-01-05, 1403/10/16
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Registrant information
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Recruitment status
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recruiting
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Funding source
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Expected recruitment start date
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2024-12-21, 1403/10/01
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Expected recruitment end date
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2025-11-22, 1404/09/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Bioequivalence study of the intravenous solution of Ferric carboxy maltose 50mg/ml (Ferririse)manufactured by Zistdaru Danesh versus originator brand (Ferinject) in healthy volunteers in the fasted condition
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Public title
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Bioequivalence study of the intravenous solution of Ferric carboxy maltose
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Weight over 50 kg
Informed consent
Age (18-55 years old)
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.
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Age
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From 18 years old to 55 years old
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Gender
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Both
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Phase
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Bioequivalence
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Groups that have been masked
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Sample size
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Target sample size:
50
More than 1 sample in each individual
Number of samples in each individual:
12
Blood sample
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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People in the mentioned age group are invited to participate through the advertisement. People are then checked for health and eligible candidates are identified. Each candidate is assigned a number from 1 to 50. The rand function of Excel software was used for randomization. The first 25 no.s are considered as (first sequence: Zistdaru Danesh's medicine ) and the second 25 no.s (second sequence: originator brand recipient). The volunteers don't have any information about taking the test or brand drug.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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This study is a single-blinded clinical trial (volunteers). The label of Zistdaru Danesh and the original brand are removed from the vials by the executor and the coded label is installed on it. Candidates don't know about receiving the type of brand medicine or test.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-12-02, 1403/09/12
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Ethics committee reference number
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IR.TBZMED.REC.1403.780
Health conditions studied
1
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Description of health condition studied
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This study is conducted on healthy volunteers.
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Plasma concentration of the drug
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Timepoint
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Before, 0.5, 0.45, 1, 2, 4, 6, 12, 24, 36, 48 and 72h after drug administration
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Method of measurement
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Liquid Chromatography Mass-Mass
Secondary outcomes
1
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Description
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Time to reach maximum plasma concentration
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Timepoint
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After intervention
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Method of measurement
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Time to reach the maximum drug concentration in plasma is recorded.
2
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Description
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Extent of absorption
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Timepoint
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After intervention
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Method of measurement
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Calculation of area under curve of concentration -time
Intervention groups
1
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Description
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Intervention group 1: injection solution of ferric carboxy maltose 50 mg/ml manufactured by Vifor Pharma company as a reference
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: injection solution of ferric carboxy maltose 50 mg/ml manufactured by Zistdaru Danesh company as a test.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Zistdaru danesh Co.
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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These data are as secure between researchers and related industries.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available