Researchers of this study evaluated the bioequivalence of once-daily and twice-daily formulations of deutetrabenazine in a randomized crossover trial involving 262 healthy adults. Participants received either 24 mg of the once-daily or 12 mg of the twice-daily formulation over seven days. The focus was on comparing plasma concentrations of deutetrabenazine and its metabolites. Results confirmed that the once-daily formulation is bioequivalent to the twice-daily version in terms of steady-state AUC and Cmax.
The study also emphasized deutetrabenazine’s improved pharmacokinetic profile, achieved by modifying its chemical structure to increase the half-life of its metabolites, thereby requiring less frequent dosing. While both formulations showed similar Cmax values, the once-daily version exhibited marginally higher AUC and Cmin values, with more stable plasma concentrations. This suggests comparable efficacy between the formulations, with the once-daily formulation potentially enhancing patient adherence.
Reference: Sunzel EM, Rabinovich-Guilatt L, Iyengar M, et al. A Bioequivalence Comparison Between the Once-Daily Extended-Release Tablet and the Twice-Daily Tablet Formulations of Deutetrabenazine at Steady State. Clin Pharmacol Drug Dev. 2024;13(3):224-232. doi: 10.1002/cpdd.1355.