Rationale and design of the CORE (COrticosteroids REvised) study: protocol.

ABSTRACT:

Introduction

Corticosteroids are an important pillar in many anti-inflammatory and immunosuppressive treatment regimens and are available in natural and synthetic forms, which are considered equipotent if clinical bioequivalence data are used. Current clinical bioequivalence data are however based on animal studies or studies with subjective endpoints. Furthermore, advancement in steroid physiology with regard to metabolism, intracellular handling and receptor activation have not yet been incorporated. Therefore, this study aims to re-examine the clinical bioequivalence and dose effects of the most widely used synthetic corticosteroids, prednisolone and dexamethasone.

Methods and analysis

In this double-blind, randomised cross-over clinical trial, 24 healthy male and female

SUBMITTER: Stam SP 

PROVIDER: S-EPMC9045047 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature