Prandial effect on the systemic exposure of amisulpride

Title
Prandial effect on the systemic exposure of amisulpride
Author(s)
강원구정태천장유정노금한백인환[백인환]권광일[권광일]김은영[김은영]윤영란[윤영란]
Keywords
HEALTHY-VOLUNTEERS; SCHIZOAFFECTIVE DISORDER; LIQUID-CHROMATOGRAPHY; HUMAN PLASMA; PHARMACOKINETICS; FOOD; SCHIZOPHRENIA
Issue Date
201410
Publisher
PHARMACEUTICAL SOC KOREA
Citation
ARCHIVES OF PHARMACAL RESEARCH, v.37, no.10, pp.1325 - 1328
Abstract
A substituted benzamide, amisulpride is an atypical antipsychotic and a specific antagonist for dopamine D-2 and D-3 receptors. The prandial effect on amisulpride absorption remains unclear, therefore, this study was designed to investigate the effect of food on the systemic exposure to amisulpride in healthy volunteers. The study was a randomized, two-way crossed trial in which a single oral dose of amisulpride was administered on two occasions, with 7-days washout period between each drug administration. The volunteers were randomly divided into two groups and received amisulpride (50 mg) with Korean traditional food or under fasting state. Blood was serially taken, and the plasma amisulpride concentrations were measured by LC/MS/MS. At fasting state, amisulpride reached the first peak (37.1 +/- A 13.3 ng/ml) at similar to 2.3 h, and decreased down to 19.4 +/- A 4.3 ng/ml until 3.5 h, and then again went up to the second peak (25.3 +/- A 5.8 ng/ml) at 5 h followed by a slow decay with 10.6 h of half-life. In contrast, no double peaks were shown when the drug was given with meal. The maximum concentration of amisulpride (56.0 +/- A 12.7 ng/ml) was increased by a 1.5-fold compared with that under fasting (p > 0.05), and the time to peak shortened a little (1.7 +/- A 0.6 h).
URI
http://hdl.handle.net/YU.REPOSITORY/30657http://dx.doi.org/10.1007/s12272-014-0331-7
ISSN
0253-6269
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약학대학 > 약학부 > Articles
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