Overview

A Study in Healthy Volunteers to Compare the Profiles of DA-3880 and EU Sourced ARANESPĀ® (Amgen)

Status:
Completed
Trial end date:
2014-11-29
Target enrollment:
Participant gender:
Summary
The main purpose of the study is to determine whether the test product and the reference product are bioequivalent based on the pharmacokinetics after administration of ug/kg as a single intravenous dose and as a single subcutaneous dose of each of the formulations. The study is consisted of randomization, 2 parts, 4 treatments, 2 way cross over.
Phase:
Phase 1
Details
Lead Sponsor:
Dong-A ST Co., Ltd.
Treatments:
Darbepoetin alfa