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Pharmacokinetics and Pharmacodynamics of CinnoVex (Interferon Beta-1a) Compared to Avonex (Interferon Beta-1a)

Cinnagen · 2017
ClinicalTrials.gov · Datasets · License: Public Domain · 2017
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The primary objective of the trial is to investigate the biosimilarity of CinnoVex® by comparing its pharmacokinetics (PK) and pharmacodynamics (PD) to its originator, Avonex®, in a crossover manner in healthy female and male volunteers after administration of a single dose of 30 µg or 60 µg of Interferon beta-1a. The secondary objectives of the study are: * To further compare the PK of CinnoVex® and Avonex®. * To further compare the PD of CinnoVex® and Avonex®. * To assess the safety of CinnoVex®.
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