Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-02-25 @ 6:53 PM
Study NCT ID:
NCT01684605
Status:
COMPLETED
Last Update Posted:
2017-05-23
First Post:
2012-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics Study of CKD-11101 and NESP After IV Administration in Health Male Volunteers
Sponsor:
Chong Kun Dang Pharmaceutical
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: