Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2026-03-02 @ 6:02 AM
Study NCT ID:
NCT02580006
Status:
UNKNOWN
Last Update Posted:
2015-10-20
First Post:
2015-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Investigate the Pharmacokinetics of EPORON® and EPREX® After Subcutaneous Administration in Healthy Male Volunteers
Sponsor:
Dong-A ST Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Active Control, Single Dosing, Crossover Clinical Trial to Investigate the Pharmacokinetics of EPORON® and EPREX® After Subcutaneous Administration in Healthy Male Volunteers
Status:
UNKNOWN
Status Verified Date:
2015-10
Last Known Status:
NOT_YET_RECRUITING
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:
This Phase I study is to compare pharmacokinetics, safety and pharmacodynamics of EPORON and EPREX after single subcutaneous administration.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: