Interim Results of the Remede d'Or Study: A Multicenter, Single-Blind, Randomized, Controlled Trial to Assess the Safety and Efficacy of an Innovative Topical Formulation of Erythropoietin for Treating Diabetic Foot Ulcers.

To inform on the interim results of the Remede d'Or study, which is a prospective, multicenter, single-blind, randomized, controlled clinical study on the safety and efficacy of RMD-G1, a topical carbopol-based hydrogel with a fibronectin matrix whose active pharmaceutical ingredient is erythropoietin (EPO), for treating diabetic foot ulcers (DFU). The trial will comprise 20 patients with type 2 diabetes mellitus with neuroischemic DFUs who will be randomized into two groups: (1) a control group in which standard-of-care (SOC) will be used to treat the DFUs, and (2) a test group in which SOC and RMD-G1 will be used to treat the DFUs. On day 0, all participants will be randomized to receive either RMD-G1 and SOC treatment or SOC alone.

Is it possible to achieve bio-equivalence between an oral solid immediate-release and an analogue enteric-coated formulation?

Objectives: While bioequivalence between enteric-coated and immediate-release formulations can be achieved in terms of AUC, gastric emptying of enteric-coated dosage forms is a stochastic event, usually leading to lower Cmax values than those observed with the corresponding immediate release. This article examines challenges of developing enteric-coated dosage forms which are bioequivalent to the corresponding immediate-release formulations in terms of both AUC and Cmax using rasagiline as a model compound.

Methods: In vitro drug release profiles of enteric-coated formulations were obtained and compared to those of the immediate-release formulation by dissolution testing.