Healthy VolunteersPhase 1NCT02391181
Bioequivalence Study With Pharmacokinetic Endpoints, Comparing a Single Dose of Iron Sucrose Azad Injection of Azad Pharma Corporation (AG), With a Single Dose of Venofer® Injection of Vifor Corporation (AG) in Healthy Adult Volunteers
A Phase 1 study testing Iron Sucrose Azad and Venofer® in people with Healthy Volunteers, run by Azad Pharma AG at 1 site in Austria.
Trial summary
A Clinical Trial to Demonstrate the Comparability of the Two Iron Sucrose Injection Solutions Iron Sucrose Azad of Azad Pharma AG and Venofer® of Vifor Pharma AG. The Hypothesis is That Both Iron Sucrose Injection Solutions Reveal the Same Active Substance Availability in the Blood Circuit. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Iron Sucrose Azad and Venofer®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2014to Aug 2015
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female 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 for female and male subjects
- Transferrin ≥ 200 mg/dl for female and male subjects
- Hemoglobin levels ≥ 12 g/dl for female subjects and ≥ 13.5 g/dl for male subjects
- Females of childbearing potential must provide a negative urine pregnancy test at time of screening and have to be compliant with effective hormonal form of birth control throughout the whole study
Who cannot join
- Subjects with a BMI of < 19 kg/m2 and > 30 kg/m2
- Pregnancy (as determined by a positive urine pregnancy test at the screening or prior each crossover phase) or breast feeding
- Females with history of hypermenorrhea or menorrhagia
- Females with history of myoma, endometriosis or uterus hypoplasia or any other gynecological disorder
- History of iron deficiency within six months prior screening
- History of anemia within 1 year prior screening
Show all 31Show fewer
- 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 Human Immunodeficiency Virus (HIV)/ Hepatitis B Virus (HBV)/ hepatitis C virus (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, 200mL wine or 50mL of spirits)or there is evidence of Cocaine, Amphetamines, Metformin, Tetrahydrocannabinol (THC), Methadone, 3,4-Methylendioxy-N-Methylamphetamin (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 and contraceptives) 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: An Open-label, Randomized, Crossover-design Bioequivalence Study With Pharmacokinetic Endpoints, Comparing a Single Dose of Iron Sucrose Azad Injection of Azad Pharma Corporation (AG), With a Single Dose of Venofer® Injection of Vifor Corporation (AG) in Healthy Adult Volunteers Under Fasting Conditions
A Clinical Trial to Demonstrate the Comparability of the Two Iron Sucrose Injection Solutions Iron Sucrose Azad of Azad Pharma AG and Venofer® of Vifor Pharma AG. The Hypothesis is That Both Iron Sucrose Injection Solutions Reveal the Same Active Substance Availability in the Blood Circuit.
Read the detailed description
A single dose 100mg Iron Sucrose Azad (5 mL single dose vial, each mL containing 20 mg/mL elemental iron as iron sucrose in water for injection) of Azad Pharma AG or a single dose 100mg Venofer® (5 mL single dose vial, iron sucrose injection, United States Pharmacopeia (USP), 20 mg/mL) will be administered to healthy adult volunteers in a crossover-design. The assignment to either test or reference product in the crossover design is based on a randomization schedule. A wash-out period of at least 5 half-lives of iron sucrose was calculated in this crossover design which accounts an overall study duration of at least 10 days (max 19 days) for each volunteer. Overall the study participant has to attend the clinical site for 5 active study days.
The study follows the recommended format outlined 2013 by the European Medicines Agency (EMA), i.e. single-dose with primary variables being AUC and Cmax of baseline corrected total- and transferrin-bound serum iron. In addition baseline non-corrected values will be analysed due to the known variability in baseline iron levels (both intra- and inter-individual).
The assays for total- and transferrin-bound serum iron will be validated, in order to ensure dependable readouts as recommended by EMA.
- Conditions
- Healthy Volunteers
- Being tested
- Iron Sucrose Azad, Venofer®
- Keywords
- Bioequivalence, Iron Status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron Sucrose AzadDrug
Test product Iron Sucrose Azad 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.
Venofer®Drug
Reference product Venofer® will be administered intravenously via a 18 gauge (18G) needle. For intravenous injection, a 5 mL single dose of reference 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 ampoule 20mg/mL elemental iron as iron sucrose in water for injection) Receives: Drug: Iron Sucrose Azad |
| reference product | Active comparator | Iron sucrose injection solution 100mg (5 mL single dose vial 20mg/mL elemental iron as iron sucrose in water 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.
Measured: -24.00, -12.00, -3.00 hours, at pre-dose (within 15 minutes prior to dosing), at 2, 5, 10, 15, 20, 30, 45 minutes and at 1.00, 1.30, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 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.
Measured: -24.00, -12.00, -3.00 hours, at pre-dose (within 15 minutes prior to dosing), at 2, 5, 10, 15, 20, 30, 45 minutes and at 1.00, 1.30, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 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.
Measured: -24.00, -12.00, -3.00 hours, at pre-dose (within 15 minutes prior to dosing), at 2, 5, 10, 15, 20, 30, 45 minutes and at 1.00, 1.30, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 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.
Measured: -24.00, -12.00, -3.00 hours, at pre-dose (within 15 minutes prior to dosing), at 2, 5, 10, 15, 20, 30, 45 minutes and at 1.00, 1.30, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 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 posted18 Mar 2015 (estimated)
- Study startNov 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT02391181
- Sponsor's protocol ID
- AZAD-BE01
- Status last verified
- Oct 2015
- First submitted
- 22 Jan 2015
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Crossover-design Bioequivalence Study With Pharmacokinetic Endpoints, Comparing a Single Dose of Iron Sucrose Azad Injection of Azad Pharma Corporation (AG), With a Single Dose of Venofer® Injection of Vifor Corporation (AG) in Healthy Adult Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT02391181
- Acronym / sponsor ID
- AZAD-BE01
- Conditions
- Healthy Volunteers
- Keywords
- Bioequivalence, Iron Status
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Azad Pharma AGIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 18 Mar 2015 (estimated)
- 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.
A Clinical Trial to Demonstrate the Comparability of the Two Iron Sucrose Injection Solutions Iron Sucrose Azad of Azad Pharma AG and Venofer® of Vifor Pharma AG. The Hypothesis is That Both Iron Sucrose Injection Solutions Reveal the Same Active Substance Availability in the Blood Circuit.
Detailed description
A single dose 100mg Iron Sucrose Azad (5 mL single dose vial, each mL containing 20 mg/mL elemental iron as iron sucrose in water for injection) of Azad Pharma AG or a single dose 100mg Venofer® (5 mL single dose vial, iron sucrose injection, United States Pharmacopeia (USP), 20 mg/mL) will be administered to healthy adult volunteers in a crossover-design. The assignment to either test or reference product in the crossover design is based on a randomization schedule. A wash-out period of at least 5 half-lives of iron sucrose was calculated in this crossover design which accounts an overall study duration of at least 10 days (max 19 days) for each volunteer. Overall the study participant has to attend the clinical site for 5 active study days.
The study follows the recommended format outlined 2013 by the European Medicines Agency (EMA), i.e. single-dose with primary variables being AUC and Cmax of baseline corrected total- and transferrin-bound serum iron. In addition baseline non-corrected values will be analysed due to the known variability in baseline iron levels (both intra- and inter-individual).
The assays for total- and transferrin-bound serum iron will be validated, in order to ensure dependable readouts as recommended by EMA.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test product | Experimental | Drug: Iron Sucrose AzadIron sucrose injection solution 100mg (5 mL single dose ampoule 20mg/mL elemental iron as iron sucrose in water for injection) |
| reference product | Active comparator | Drug: Venofer®Iron sucrose injection solution 100mg (5 mL single dose vial 20mg/mL elemental iron as iron sucrose in water for injection) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male and female 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 for female and male subjects
- Transferrin ≥ 200 mg/dl for female and male subjects
Key exclusion criteria (31 listed)
- Subjects with a BMI of < 19 kg/m2 and > 30 kg/m2
- Pregnancy (as determined by a positive urine pregnancy test at the screening or prior each crossover phase) or breast feeding
- Females with history of hypermenorrhea or menorrhagia
- Females with history of myoma, endometriosis or uterus hypoplasia or any other gynecological disorder
- History of iron deficiency within six months prior screening
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 |
|---|---|---|
| Iron Sucrose AzadTest product Iron Sucrose Azad 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 |
| Venofer®Reference product Venofer® will be administered intravenously via a 18 gauge (18G) needle. For intravenous injection, a 5 mL single dose of reference 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: -24.00, -12.00, -3.00 hours, at pre-dose (within 15 minutes prior to dosing), at 2, 5, 10, 15, 20, 30, 45 minutes and at 1.00, 1.30, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 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: -24.00, -12.00, -3.00 hours, at pre-dose (within 15 minutes prior to dosing), at 2, 5, 10, 15, 20, 30, 45 minutes and at 1.00, 1.30, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours post-dose.
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: -24.00, -12.00, -3.00 hours, at pre-dose (within 15 minutes prior to dosing), at 2, 5, 10, 15, 20, 30, 45 minutes and at 1.00, 1.30, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 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: -24.00, -12.00, -3.00 hours, at pre-dose (within 15 minutes prior to dosing), at 2, 5, 10, 15, 20, 30, 45 minutes and at 1.00, 1.30, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 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 2 Oct 2015.
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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 Iron Sucrose Azad and Venofer® in people with Healthy 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 7 inclusion and 31 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 2 Oct 2015. 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: -24.00, -12.00, -3.00 hours, at pre-dose (within 15 minutes prior to dosing), at 2, 5, 10, 15, 20, 30, 45 minutes and at 1.00, 1.30, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 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 2 Oct 2015.