Overview

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

Status:
Completed

Trial end date:
2016-04-11

Target enrollment:

Participant gender:

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.

Phase:

Phase 1

Details

Lead Sponsor:

Hoffmann-La Roche

Treatments:

Benzyl Alcohol
Interferon alpha-2
Interferon-alfa-1b
Interferon-alpha
Peginterferon alfa-2a