NCT01684605

Pharmacokinetics Study of CKD-11101 and NESP After IV Administration in Health Male Volunteers

A Randomized, Double-blind, Active Control, Single Dosing, Crossover Clinical Trial to Investigate the Pharmacokinetics of CKD-11101 and NESP After IV Administration in Health Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the pharmacokinetics of CKD-11101 and NESP after IV administration in health male volunteers

Detailed description

Healthy volunteers are administrated CKD-11101 60μg and NESP 60μg once intravenously. (crossover) Every time before and after taking each medication, PK parameters and safety of CKD-11101 60μg and NESP 60μg are performed using a blood sample and conducting some tests(Laboratory test, V/S and Physical Examination, etc) respectively.

Conditions

• Anemia

Interventions

Type	Name	Description
DRUG	NESP 60μg	Administrated NESP 60μg once intravenously
DRUG	CKD-11101 60μg	Administrated CKD-11101 60μg once intravenously

Timeline

• Start date: 2012-10-12
• Primary completion: 2012-11-13
• Completion: 2013-01-03
• First posted: 2012-09-13
• Last updated: 2017-05-23

Locations

1 site across 1 country: South Korea