Bioequivalence Study of Tasimelteon Capsule vs. Suspension in Healthy Volunteers

Phase 1, randomised, open-label trial of tasimelteon in Non-24-hour sleep-wake disorder (N24SWD) and Smith-Magenis syndrome (SMS) (2 arms), sponsored by Vanda Pharmaceuticals Inc. Primary endpoints: Bioequivalence between tasimelteon capsule formulation relative to tasimelteon liquid suspension formulation at 8 hours and Assessment of Safety and Tolerability of the liquid suspension and capsule formulation of tasimelteon at 7 days. Started May 2022; status: completed.