A Randomized, Open-Label, Single-Dose, Parallel-Design, Bioequivalence Study of Hospira Iron Sucrose Injection Compared to Venofer® Injection USP in Healthy Subjects.

NCT00719459 Phase 1 COMPLETED

The primary objective of this study is to assess the bioequivalence of the test product Hospira Iron Sucrose 20 mg/mL (Hospira, Inc.) to the reference product Venofer® 20 mg/mL following intravenous administration to healthy subjects.

Details

Lead sponsor	Hospira, now a wholly owned subsidiary of Pfizer
Phase	Phase 1
Status	COMPLETED
Enrolment	60
Start date	2008-06
Completion	2008-07-13

Conditions

• Healthy Volunteers

Interventions

• Iron Sucrose
• Iron Sucrose

Primary outcomes

• Bioequivalence - Assessed by constructing the 90% confidence interval (CI) for the geometric mean test/reference ratios of Cmax for both baseline-adjusted total iron and baseline-adjusted transferrin-bound iron — Pharmacokinetic sampling at pre-dose (15, 10 and 5 minutes) and Post-dose 5, 10, 20, 30, 45 minutes, and 1.0,2.0,3.0,4.0,6.0,8.0, 12.0, 14.0, and 24.0 hours.
  Test: Hospira Iron Sucrose Injection; Reference: Venofer Injection
• Bioequivalence - Assessed by constructing the 90% CI for the geometric mean test/reference ratios of AUC0-t for both baseline-adjusted total iron and baseline-adjusted transferrin-bound iron — Pharmacokinetic sampling at pre-dose (15, 10 and 5 minutes) and Post-dose 5, 10, 20, 30, 45 minutes, and 1.0,2.0,3.0,4.0,6.0,8.0, 12.0, 14.0, and 24.0 hours.
  Test: Hospira Iron Sucrose Injection; Reference: Venofer Injection

Countries

United States