49
Participants
Start Date
August 31, 2009
Primary Completion Date
March 31, 2013
Study Completion Date
August 31, 2013
Ferric Carboxymaltose (FCM)
One 500 mg dose at 100 mg/minute (Cohort I) or 750 mg dose at 100 mg/minute (Cohort II)
Iron Sucrose / Iron Dextran
One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I), or a 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)
Luitpold Pharmaceuticals, Inc., Norristown
Lead Sponsor
American Regent, Inc.
INDUSTRY