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

NCT ID: NCT03093883

Last Updated: 2018-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-13
• Study Completion Date: 2018-06-26

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Test product

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

Group Type: EXPERIMENTAL

Ferrinemia

Intervention Type: 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.

Reference product

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

Group Type: ACTIVE_COMPARATOR

Venofer

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Azad Pharma AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

2016-003602-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AZAD-BE03

Identifier Type: -

Identifier Source: org_study_id