Bioequivalence of Aripiprazole Oral Soluble Films and Orally Disintegrating Tablets in Healthy Participants: A Crossover Study.

ABSTRACT: Schizophrenia is a serious mental disorder with high disability rates, and antipsychotics, especially second-generation ones like aripiprazole, are the cornerstone of treatment. As a novel formulation, oral soluble films (OSF) offer an alternative to tablets or capsules, improving patient compliance. This study aimed to assess the bioequivalence, pharmacokinetic (PK) properties, and safety of aripiprazole OSF and aripiprazole orally disintegrating tablets (ODT) in healthy Chinese participants. A single-dose, randomized, open-label, and crossover study was conducted. Participants received 10 mg of test aripiprazole OSF (Qilu Pharmaceutical) and reference aripiprazole ODT (Otsuka Pharmaceutical) under fasting and fed states. The fasting trial comprised a three-sequence, three-period design,

SUBMITTER: Li R 

PROVIDER: S-EPMC11817677 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature