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

NCT02391181 | Completed Phase 1

• 1 other identifier: AZAD-BE01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Bioequivalence; Iron Status

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.

  -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.

  -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.

  -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.

  -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.

Study Arms (2)

test product

EXPERIMENTAL

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

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)

Drug: Venofer®

Interventions

Iron Sucrose Azad DRUG

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.

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 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.

reference product

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Azad Pharma AG: lead

Study Sites (1)

Medical University of Vienna

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
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: March 18, 2015
• Study Start: November 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 2, 2015

Record last verified: 2015-10

Locations

AU (1)