Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-29 @ 7:57 PM
Study NCT ID:
NCT01431404
Status:
COMPLETED
Last Update Posted:
2013-07-08
First Post:
2011-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetic Characteristics of HD203 Liq. in Healthy Subjects
Sponsor:
Hanwha Chemical
Organization:
Study Overview
Official Title:
Randomized,Double-blind,Single-dosing,Crossover Study to Compare the Safety and Pharmacokinetic Characteristics of HD203 With Active Comparator
Status:
COMPLETED
Status Verified Date:
2013-07
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 compare the safety and pharmacokinetic characteristics of HD203 liquid with those of etanercept (enbrel) prefilled injection after subcutaneous injection.
Detailed Description:
A randomized, double-blind, single-dosing, crossover study to compare the safety and pharmacokinetic characteristics of HD203 Liquid 25 mg with those of Enbrel Prefilled® injection 25 mg after subcutaneous injection.
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?: