NCT02391181

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Azad Pharma AG · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DRUG	Iron Sucrose Azad	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.
DRUG	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.

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2015-03-18
• Last updated: 2015-10-02

Locations

1 site across 1 country: Austria