Clinical Trial: Pharmacokinetics, Pharmacodynamics and Safety Study of Z-213 to Iron Deficiency Anemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: "Phase Ib Study of Z-213 in Subjects With Iron-deficiency Anemia - To Investigate the Safety, Tolerability Pharmacokinetics and Pharmacodynamics -"

Brief Summary: The safety, tolerability, pharmacokinetics and pharmacodynamics of Z-213 will be investigated in patients with iron-deficiency anemia after administration of a single dose (100 mg, 500 mg, 800 mg or 1,000 mg iron).

Detailed Summary:
Sponsor: Zeria Pharmaceutical

Current Primary Outcome: Pharmacokinetics of total serum iron (Cmax), (Tmax), (AUC0-t), (AUC0-24),(AUC0-72),(T1/2), (CL), (Vd, area), (Vd, ss), (MRT) or total urine iron (CLren), (Ae). [ Time Frame: 8days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Zeria Pharmaceutical

Dates:
Date Received: June 10, 2014
Date Started: June 2014
Date Completion:
Last Updated: March 19, 2015
Last Verified: March 2015