NCT02573025 - 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 | Biotech Hunter

Enrollment

277

Participants

Timeline

Start Date

September 17, 2015

Primary Completion Date

April 11, 2016

Study Completion Date

April 11, 2016

Conditions

Healthy Volunteers

Interventions

DRUG

PEG-IFN alfa-2a BA-free formulation (Test)

Participants will receive single injection of 180 micrograms (mcg) of PEG-IFN alfa-2a BA-free formulation, subcutaneously via prefilled syringe in either period 1 and 2 (each period having 35 days).

DRUG

PEG-IFN alfa-2a market formulation (Reference)

Participants will receive single injection of 180 mcg of PEG-IFN alfa-2a market formulation, subcutaneously via prefilled syringe in either period 1 and 2 (each period having 35 days).

Trial Locations (9)

110

Taipei Medical University Hospital; Clinical Research Center, Taipei

404

China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H, Taichung

1010

Auckland Clinical Studies Limited, Grafton

5000

CMAX A division of IDT Australia Limited, Adelaide

8011

Christchurch Clinical Studies Trust, Christchurch

169608

SingHealth Investigational Medicine Unit; Haematology, Singapore

529889

Changi General Hospital- Parent; Department of Rheumatology, Singapore

Unknown

The University of Hong Kong; Pharmacy Clinical Trials, Hong Kong

00000

The Chinese University of Hong Kong; Emergency Medicine, Shatin

All Listed Sponsors

lead

Hoffmann-La Roche

INDUSTRY