Trial reportDrugs in R&D2025
Bioequivalence and Safety of Two Amisulpride Formulations in Healthy Chinese Subjects Under Fasting and Fed Conditions: A Randomized, Open‑Label, Single‑Dose, Crossover Study.
Trial report in Drugs in R&D, 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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Authors and funding
6 authors.
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Abstract
BACKGROUND AND
objectivesAmisulpride is a second-generation antipsychotic drug that selectively binds to D2 and D3 dopaminergic receptors in the limbic system. In this study, the bioequivalence of an amisulpride formulation manufactured in China with the original formulation Solian® was evaluated under fasting and fed conditions in healthy Chinese subjects.
methodsA single-centre, randomized, open, two-preparation, single-dose, two-period crossover trial in healthy adult subjects was conducted under fasting and fed conditions. A total of 42 and 36 eligible healthy subjects were enrolled in the fasting and fed studies, respectively. The subjects were randomly assigned to receive either the test or the reference formulation with a washout period of 7 days. The concentration of amisulpride in plasma was determined by liquid chromatography‒tandem mass spectrometry (LC‒MS/MS), and the pharmacokinetic (PK) parameters of amisulpride were calculated via the noncompartmental method.
resultsThe geometric mean ratios (GMR) of the maximum observed concentration (C
conclusionsThe test and reference amisulpride formulations were bioequivalent under fasting and fed conditions. Both formulations showed similar safety and tolerability in the population studied.
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