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Archives of Pharmacal Research

, Volume 37, Issue 10, pp 1325–1328 | Cite as

Prandial effect on the systemic exposure of amisulpride

  • Yoo-Jung Jang
  • Tae Cheon Jeong
  • Keumhan Noh
  • In-Whan Baek
  • Kwang-il Kwon
  • Eunyoung Kim
  • Young-Ran Yoon
  • Wonku Kang
Research Article

Abstract

A substituted benzamide, amisulpride is an atypical antipsychotic and a specific antagonist for dopamine D2 and D3 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 ± 13.3 ng/ml) at ~2.3 h, and decreased down to 19.4 ± 4.3 ng/ml until 3.5 h, and then again went up to the second peak (25.3 ± 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 ± 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 ± 0.6 h).

Keywords

Amisulpride Food Systemic exposure 

Notes

Acknowledgments

This study was supported by Yeungnam University research grant in 2010.

Conflict of interests

The authors declare no competing financial interests.

References

  1. Barclay, L. 2002. Aisulpride vs. risperidone in chronic schizophrenia: results of a 6-month double-blind study. Neuropsychopharmacology 27: 1071–1081.CrossRefGoogle Scholar
  2. Bergemanna, N., J. Kopitzb, K.R. Kressa, and A. Fricka. 2004. Plasma amisulpride levels in schizophrenia or schizopaffective disorder. European Neuropsychopharmacology 14: 245–250.CrossRefGoogle Scholar
  3. Chen, N., C. Kasserra, J. Reyes, L. Liu, and H. Lau. 2012. Single-dose pharmacokinetics of lenalidomide in healthy volunteers: dose proportionality, food effect, and racial sensitivity. Cancer Chemotherapy and Pharmacology 70: 717–725.PubMedCrossRefGoogle Scholar
  4. Gschwend, M.H., P. Arnold, J. Ring, and W. Martin. 2006. Selective and sensitive determination of amisulpride in human plasma by liquid chromatography-tandem mass spectrometry with positive electrospray ionisation and multiple reaction monitoring. Journal of Chromatography B 831: 132–139.CrossRefGoogle Scholar
  5. Hamon-Vilcot, B., S. Chaufour, C. Deschamps, M. Canal, I. Zieleniuk, P. Ahtoy, P. Chretien, P. Rosenzweig, A. Nasr, and F. Piette. 1998. Safety and pharmacokinetics of a single oral dose of amisulpride in healthy elderly volunteers. European Journal of Clinical Pharmacology 54: 405–409.PubMedCrossRefGoogle Scholar
  6. Kang, W., K. Kim, E.Y. Kim, K. Kwon, J.S. Bang, and Y.R. Yoon. 2008. Effect of food on systemic exposure to niflumic acid following postprandial administration of talniflumate. European Journal of Clinical Pharmacology 64: 1027–1030.PubMedCrossRefGoogle Scholar
  7. Kim, E.Y., and W. Kang. 2011. Contribution of pH to systemic exposure of niflumic acid following oral administration of talniflumate. European Journal of Clinical Pharmacology 67: 425–428.PubMedCrossRefGoogle Scholar
  8. Lim, H.K., S.J. Kim, C.U. Pae, C. Lee, and C.U. Lee. 2007. Comparison of amisulpride and risperidone in the treatment of psychosis in patients with dementia of the Alzheimer’s type. Journal of Korean Geriatric Psychiatry 11: 35–39.Google Scholar
  9. Malavasi, B., M. Locatelli, M. Ripamonti, and V. Ascalone. 1996. Determination of amisulpride, a new benzamide derivative, in human plasma and urine by liquid–liquid extraction or solid-phase extraction in combination with high-performance liquid chromatography and fluorescence detection. application to pharmacokinetics. Journal of Chromatography B 676: 107–115.CrossRefGoogle Scholar
  10. Müller, M.J., F.X. Eich, B. Regenbogen, J. Sachse, S. Härtter, and C. Hiemke. 2009. Amisulpride doses and plasma levels in different age groups of patients with schizophrenia or schizoaffective disorder. Journal of Psychopharmacology 23: 278–286.PubMedCrossRefGoogle Scholar
  11. Nuss, P., M. Hummer, and C. Tessier. 2007. The use of amisulpride in the treatment of acute psychosis. Therapeutics and Clinical Risk Management 3: 3–11.PubMedCrossRefPubMedCentralGoogle Scholar
  12. Rosenzweig, P., M. Canal, A. Patat, L. Bergougnan, I. Zieleniuk, and G. Bianchetti. 2002. A review of the pharmacokinetics, tolerability and pharmacodynamics of amisulpride in healthy volunteers. Human Psychopharmacology 17: 1–13.PubMedCrossRefGoogle Scholar
  13. Won, C.S., N.H. Oberlies, and M.F. Paine. 2012. Mechanisms underlying food-drug interactions: inhibition of intestinal metabolism and transport. Pharmacology & Therapeutics 136: 186–201.CrossRefGoogle Scholar
  14. Yun, H.Y., M.S. Baek, and K.I. Kwon. 2006a. The effect of food on absorption of drug in the gastrointestinal tract. Korean Journal of Clinical Pharmacy 16: 147–154.Google Scholar
  15. Yun, H.Y., E.J. Lee, S.Y. Chung, S.O. Choi, H.K. Kim, J.T. Kwon, W. Kang, and K.I. Kwon. 2006b. The effects of food on the bioavailability of fenofibrate administered orally via sustained-release capsules in humans. Clinical Pharmacokinetics 45: 425–432.PubMedCrossRefGoogle Scholar

Copyright information

© The Pharmaceutical Society of Korea 2014

Authors and Affiliations

  • Yoo-Jung Jang
    • 1
  • Tae Cheon Jeong
    • 1
  • Keumhan Noh
    • 1
  • In-Whan Baek
    • 2
  • Kwang-il Kwon
    • 3
  • Eunyoung Kim
    • 4
  • Young-Ran Yoon
    • 5
  • Wonku Kang
    • 4
  1. 1.College of PharmacyYeungnam UniversityKyoungbukSouth Korea
  2. 2.College of PharmacyKyungsung UniversityBusanSouth Korea
  3. 3.College of PharmacyChungnam National UniversityDaejeonSouth Korea
  4. 4.College of PharmacyChung-Ang UniversitySeoulSouth Korea
  5. 5.Department of Molecular Medicine and Clinical Trial Center, BK21 Plus KNU Bio-Medical Convergence Program for Creative Talent, Graduates School of MedicineKyungpook National University and KNUHDaeguSouth Korea

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