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

NCT03093883 | Completed Phase 1

• 2 other identifiers: AZAD-BE032016-003602-14
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (2)

• 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.

  -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.

  -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.

  -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.

  -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.

Study Arms (2)

Test product

EXPERIMENTAL

Iron sucrose injection solution 100mg (5 mL single dose vial 20mg/mL elemental iron as iron sucrose for injection).

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).

Drug: Venofer

Interventions

Ferrinemia DRUG

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.

Test product

Venofer DRUG

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.

Reference product

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azad Pharma AG: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Interventions

Ferric Oxide, Saccharated

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: March 28, 2017
• Study Start: March 13, 2017
• Primary Completion: November 14, 2017
• Study Completion: June 26, 2018
• Last Updated: July 5, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)