Trial reportClinical and translational science2025
Bioequivalence of Aripiprazole Oral Soluble Films and Orally Disintegrating Tablets in Healthy Participants: A Crossover Study.
Trial report in Clinical and translational science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
8 authors.
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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, while the fed trial comprised a two-sequence, two-period design. In the fasting trial, after single oral dosing of aripiprazole OSF (with water), aripiprazole OSF (without water), and aripiprazole ODT, C
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