Viewing Study NCT02573025



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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