Bioequivalence Study Comparing Single Dose of Ferrinemia® Injection With a Single Dose of Venofer® Injection in Healthy Male Volunteers

July 3, 2018 updated by: Azad Pharma AG

Open-label, Randomized, Crossover-design Bioequivalence Study With Comparing a Single Dose of Ferrinemia® Injection With a Single Dose of Venofer® Injection of Vifor AG in Healthy Male Volunteers

The aim of this pharmacokinetic study is to assess the bioequivalence of the generic Ferrinemia® Iron Sucrose injection solution 20 mg/mL manufactured by Help S.A., Greece (test product), to Venofer® Iron Sucrose injection solution 20 mg/mL manufactured by Vifor AG, Switzerland (reference product). Both formulations contain iron as an active ingredient. Intravenous iron sucrose is primarily indicated for the treatment of iron deficiency anemia in adult patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male healthy volunteers within the age range of 18 to 45 years (both inclusive)
  • Comprehension of the nature and purpose of the study and willingness to comply with the requirements of the entire procedure
  • Subjects of good health based on previous medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests assessed at the time of screening
  • Ferritin levels ≥ 30 µg/l
  • Transferrin ≥ 200 mg/dl
  • Hemoglobin levels ≥ 13.5 g/dl

Exclusion Criteria:

  • Subjects with a BMI of < 19 kg/m2 and > 30 kg/m2
  • History of iron deficiency within six months prior screening
  • History of anemia within 1 year prior screening
  • Presence of iron overload or disturbances in utilization of iron
  • History or evidence of allergy or hypersensitivity to the active substance Iron Sucrose of both test and reference product, the finished test and reference product or any of its excipients (water for injection, sodium hydroxide)
  • Hypersensitivity to other parenteral iron products
  • Use of iron supplements or iron containing herbal or nutritional supplements within last three months prior to start of the study
  • History of difficulty with donating blood or difficulty in accessibility of veins in left and right arm
  • Donation of blood (one unit or 350 mL) within last three months prior first dose administration of the study drug
  • Evidence of an active or suspected cancer, or a history of malignancy within the last 2 years, with the exception of patients with basal cell carcinoma that has been excised and cured
  • History of any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
  • History of bleeding disorders or anticoagulant use
  • History or other evidence of chronic pulmonary or cardiovascular disease associated with functional limitation
  • History of uncontrolled severe seizure disorder
  • Any signs of acute infection or inflammation
  • History or other evidence of severe illness, or any other condition which would make the subject in the opinion of the investigator, unsuitable for the study.
  • Any clinically significant abnormal laboratory values on the laboratory evaluations, medical history or physical examination at the screening
  • Positive HIV/HBV/HCV serology tests at the time of the screening visit
  • Abnormal 12-lead ECG at the time of screening that is considered to be clinically significant
  • History or presence of severe or medical treated allergies or immune or inflammatory conditions (eg. systemic lupus erythematosus, rheumatoid arthritis)
  • History of atopic allergy associated with severe asthma
  • Recent history or ongoing kidney or liver dysfunction
  • Any other major illness in last three months or any significant ongoing chronic medical illness
  • Subjects who regularly use more than 2 units of alcohol per day (one unit of alcohol equals ½ liter of beer, 200 mL wine or 50 mL of spirits) or there is evidence of Cocaine, Amphetamines, Methformin, THC, Methadone, MDMA, Morphine, Barbiturates, Benzodiazepines and Tricyclic antidepressants in urine at the screening)
  • Heavy smokers (> 10 cigarettes/day) in the last three months prior to start of the study
  • Any concomitant medication (except paracetamol) within the last two weeks, including over-the-counter and herbal products, prior to receiving the dose of study medication
  • Participation in any clinical trial within last one months
  • Subjects who are considered by the investigator to be non-compliant or unlikely to complete the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test product
Iron sucrose injection solution 100mg (5 mL single dose vial 20mg/mL elemental iron as iron sucrose for injection).
Drug: Ferrinemia
Test product Ferrinemia will be administered intravenously via a 18 gauge (18G) needle. For intravenous injection, a 5 mL single dose of test product (each mL containing 20 mg/mL elemental iron as iron sucrose in water for injection) will be diluted in 0.9% isotonic sterile sodium chloride (NaCl) up to 15 mL. The injection solution will be intravenously administered to the forearm vein, resulting in a total injection volume of 15 mL administered over a period of 5 minutes.
Active Comparator: Reference product
Iron sucrose injection solution 100mg (5 mL single dose ampoule 20mg/mL elemental iron as iron sucrose for injection).
Drug: Venofer
Reference product Venofer will be administered intravenously via a 18 gauge (18G) needle. For intravenous injection, a 5 mL single dose of test product (each mL containing 20 mg/mL elemental iron as iron sucrose in water for injection) will be diluted in 0.9% isotonic sterile sodium chloride (NaCl) up to 15 mL. The injection solution will be intravenously administered to the forearm vein, resulting in a total injection volume of 15 mL administered over a period of 5 minutes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Comparative assessment of peak plasma concentration (Cmax) of baseline corrected total serum iron and serum transferrin-bound iron after administration of test and reference product.
Time Frame: -pre-dose -15 minutes and within 5 minutes prior to dosing, at 2, 5, 10, 15, 20, 30, 45 minutes and at 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00, 30.00 hours post-dose.
bioequivalence between test und reference product of iron sucrose for Cmax of baseline corrected total serum iron and serum transferrin-bound iron.
-pre-dose -15 minutes and within 5 minutes prior to dosing, at 2, 5, 10, 15, 20, 30, 45 minutes and at 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00, 30.00 hours post-dose.
Comparative assessment of the area under the plasma concentration versus time curve (AUC) of baseline corrected total serum iron and serum transferrin-bound iron after administration of test and reference product.
Time Frame: -pre-dose -15 minutes and within 5 minutes prior to dosing, at 2, 5, 10, 15, 20, 30, 45 minutes and at 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00, 30.00 hours post-dose.
bioequivalence between test und reference product of iron sucrose for AUC of baseline corrected total serum iron and serum transferrin-bound iron.
-pre-dose -15 minutes and within 5 minutes prior to dosing, at 2, 5, 10, 15, 20, 30, 45 minutes and at 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00, 30.00 hours post-dose.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparative assessment of peak plasma concentration (Cmax) of non-baseline corrected total serum iron and serum transferrin-bound iron after administration of test and reference product.
Time Frame: -pre-dose -15 minutes and within 5 minutes prior to dosing, at 2, 5, 10, 15, 20, 30, 45 minutes and at 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00, 30.00 hours post-dose.
bioequivalence between test und reference product of iron sucrose for Cmax of non-baseline corrected total serum iron and serum transferrin-bound iron.
-pre-dose -15 minutes and within 5 minutes prior to dosing, at 2, 5, 10, 15, 20, 30, 45 minutes and at 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00, 30.00 hours post-dose.
Comparative assessment of the area under the plasma concentration versus time curve (AUC) of non-baseline corrected total serum iron and serum transferrin-bound iron after administration of test and reference product.
Time Frame: -pre-dose -15 minutes and within 5 minutes prior to dosing, at 2, 5, 10, 15, 20, 30, 45 minutes and at 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00, 30.00 hours post-dose.
bioequivalence between test und reference product of iron sucrose for AUC of non-baseline corrected total serum iron and serum transferrin-bound iron.
-pre-dose -15 minutes and within 5 minutes prior to dosing, at 2, 5, 10, 15, 20, 30, 45 minutes and at 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00, 30.00 hours post-dose.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azad Pharma AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 14, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 26, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AZAD-BE03
  • 2016-003602-14 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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