Фармакокинетика и Фармакодинамика (Apr 2014)

Bioequivalence studies Nipezam retard tablets, 400 mg (JSC «Himfarm», Kazakhstan) and Finlepsin® 400 retard tablets 400 mg («Pliva Krakow, SA Pharmaceutical company», Poland)

  • A. K. Sariev,
  • D. A. Abaimov,
  • M. V. Tankevich,
  • Y. . Budach,
  • O. . Kurilov,
  • S. A. Altinbekov,
  • G. A. Dzholdygulov,
  • V. N. Seryakov,
  • K. S. Altinbekov

Journal volume & issue
Vol. 0, no. 1
pp. 27 – 34

Abstract

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In a single-dose, two-treatment, two-period, two-sequence crossover study with a 1-month washout period was carry out the bioequivalence study of two tablet coated formulation of carbamazepine that given to 18 volunteers in equal doses (400 mg). Drug blood plasma concentrations were determined by validated LC-UV method for 120 hours. There were calculated the followed parameters: AUC0-t, Cmax , Tmax, Cmax /AUC. 90% confidence interval for log-transformed AUC. values was 0,93693 - 1,10204 and one for log-transformed Cmax was 0,91045 - 1,12287, respectively. It was made the conclusion about bioequivalence of compared carbamazepine formulations.

Keywords