Semaglutide formulations DV3396 and PDS290 compared for bioequivalence in healthy volunteers

The development of new drug delivery systems or manufacturing processes for established medications like semaglutide necessitates rigorous testing to ensure consistent patient outcomes. Bioequivalence studies are crucial to confirm that different formulations or production methods yield comparable systemic exposure and therapeutic effects. This is particularly vital for chronic conditions like Type 2 Diabetes Mellitus and obesity, where consistent drug levels are paramount for efficacy and safety. Ensuring bioequivalence allows for flexibility in manufacturing and supply chain without compromising patient care, addressing potential gaps in drug availability or delivery device innovation.

This was a Phase 1, randomized, open-label, two-period crossover study involving 18 healthy volunteers. Participants received a single subcutaneous dose of 0.5 mg Semaglutide B (1.34 mg/mL) in one period and a single subcutaneous dose of 0.5 mg Semaglutide D (1.0 mg/mL) in the other, with a washout period between doses. The primary objective was to demonstrate bioequivalence between the two semaglutide formulations, DV3396 and PDS290 pen-injectors, by comparing pharmacokinetic parameters such as area under the curve (AUC) and maximum concentration (Cmax). The study design aimed to minimize inter-individual variability by having each subject serve as their own control.