Фармакокинетика и Фармакодинамика (Sep 2013)

Comparative bioequivalence study of Pioglitazone tablets, 20 mg (JSC «Chimpharm», Kazakhstan) and Actos® Tablets, 30 mg («Eli Lilly Holdings, Takeda Global Research and Development Centre Europe Ltd»)

  • A. K. Sariev,
  • D. A. Abaimov,
  • M. V. Shiryaev,
  • E. Y. Styrova,
  • S. A. Altynbekov,
  • G. A. Dzholdygulov,
  • V. N. Seryakov,
  • Y. M. Budach,
  • O. E. Kurilo

Journal volume & issue
Vol. 0, no. 2
pp. 25 – 32

Abstract

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Within the cross, a single, open, randomized study with a two-week washout period, the two sequences has been studied bioequivalence of tablet forms two pioglitazone 18 volunteers (30 mg dosage). Plasma samples were analyzed by a validated HPLC-MS/MS within 48 hours. Analyzed for drugs following pharmacokinetic parameters were calculated: AUC0-t, Cmax, tmax, Cmax /AUC. 90% confidence interval for log-transformed values of AUC0-t was 0.945 — 1.066 and Cmax — 0,871 — 1,044. The study concluded that bioequivalence compared pioglitazone drugs.

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