Heathy VolunteersPhase 1NCT03093883
Bioequivalence Study Comparing Single Dose of Ferrinemia® Injection With a Single Dose of Venofer® Injection in Healthy Male Volunteers
A Phase 1 study testing Ferrinemia and Venofer in people with Heathy Volunteers, run by Azad Pharma AG at 1 site in Austria.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Heathy Volunteers
- What is being tested?
- Ferrinemia and Venofer
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteAustria
- Study dates
- 13 Mar 2017to 26 Jun 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 28Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Heathy Volunteers
- Being tested
- Ferrinemia, Venofer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerrinemiaDrug
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.
VenoferDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Test product | Experimental | Iron sucrose injection solution 100mg (5 mL single dose vial 20mg/mL elemental iron as iron sucrose for injection). Receives: Drug: Ferrinemia |
| Reference product | Active comparator | Iron sucrose injection solution 100mg (5 mL single dose ampoule 20mg/mL elemental iron as iron sucrose for injection). Receives: Drug: Venofer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
bioequivalence between test und reference product of iron sucrose for Cmax of baseline corrected total serum iron and serum transferrin-bound iron.
Measured: -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.
bioequivalence between test und reference product of iron sucrose for AUC of baseline corrected total serum iron and serum transferrin-bound iron.
Measured: -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 outcomes (2)
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.
bioequivalence between test und reference product of iron sucrose for Cmax of non-baseline corrected total serum iron and serum transferrin-bound iron.
Measured: -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.
bioequivalence between test und reference product of iron sucrose for AUC of non-baseline corrected total serum iron and serum transferrin-bound iron.
Measured: -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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start13 Mar 2017
- Primary completion14 Nov 2017
- Study completion26 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heathy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azad Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093883
- Sponsor's protocol ID
- AZAD-BE03
- Other IDs
- 2016-003602-14, 2016
- Status last verified
- Jul 2018
- First submitted
- 16 Feb 2017
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03093883
- Acronym / sponsor ID
- AZAD-BE03
- Conditions
- Heathy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Azad Pharma AGIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 14 Nov 2017 (actual)
- Study completion
- 26 Jun 2018 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test product | Experimental | Drug: FerrinemiaIron sucrose injection solution 100mg (5 mL single dose vial 20mg/mL elemental iron as iron sucrose for injection). |
| Reference product | Active comparator | Drug: VenoferIron sucrose injection solution 100mg (5 mL single dose ampoule 20mg/mL elemental iron as iron sucrose for injection). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (28 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FerrinemiaTest 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. | Drug | Test product |
| VenoferReference 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. | Drug | Reference product |
Primary outcome
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.
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.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ferrinemia and Venofer in people with Heathy Volunteers, run by Azad Pharma AG at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.