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

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.

Timeline

Start

2014-08-18

Primary completion

2014-11-29

Completion

2014-11-29

Drugs

Indications