Bioequivalence and food effect assessment for a new risdiplam tablet formulation in healthy volunteers

Le résumé fourni par la source

The approved risdiplam dose for patients weighing ≥20kg is 5 mg. The current available formulation is an oral solution that is drawn up in a syringe every day. A bioequivalent tablet formulation would provide patients weighing ≥20kg with a simpler daily option of swallowing a tablet or dispersing it in water. Part 1 of this healthy volunteer study (NCT04718181) assessed the relative oral bioavailability and the effects of food and stomach pH on, two new risdiplam tablet formulations Part 2 of the study assessed the bioequivalence and food effect of the most promising tablet formulation from Part 1 versus oral risdiplam solution. Using a four-way crossover design, each volunteer randomly received a single dose of 5 mg risdiplam oral solution in both fed and fasted states, and a single 5 mg risdiplam tablet (either swallowed whole or dispersed in water) in both fed and fasted states. The new risdiplam 5 mg tablet formulation was shown to be bioequivalent to the oral solution of risdiplam, based on the pharmacokinetic parameters area under the concentration-time curve and maximum concentration. In addition, no relevant impact of food on the exposure of risdiplam for either the oral solution or the tablet was found.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.