Ignite Creation Date:
2024-05-06 @ 7:38 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02573025
Status:
COMPLETED
Last Update Posted:
2017-03-13
First Post:
2015-10-08
Brief Title:
A Bioequivalence Study of Pegylated Interferon Alfa-2a PEG-IFN Alfa-2a Benzyl Alcohol BA-Free Formulation Versus PEG-IFN Alfa-2a Pegasys Following Subcutaneous Administration
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open-Label Randomized Multi-Center Single Dose Two-Period Two Sequence Crossover Study to Investigate the Bioequivalence of Peginterferon PEG-IFN Alfa-2a Benzyl Alcohol-Free Formulation Versus the Reference Market Formulation Following Subcutaneous Administration Via Prefilled Syringe in Healthy Chinese Subjects
Status:
COMPLETED
Status Verified Date:
2017-03
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:
This is an open-label randomized multi-center single dose two-period two-sequence crossover study to investigate the bioequivalence of PEG-IFN alfa-2a BA-free formulation versus the reference market formulation PEG-IFN alfa-2a Pegasys following subcutaneous administration via prefilled syringe in healthy Chinese participants
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None