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»)
Abstract
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.
About the Authors
A. K. Sariev
FGBI «Neurology Research Center», RAMS
Russian Federation
Russian Federation
D. A. Abaimov
FGBI «Neurology Research Center», RAMS
Russian Federation
Russian Federation
M. V. Shiryaev
FGBI «Neurology Research Center», RAMS
Russian Federation
Russian Federation
E. Y. Styrova
FGBI «Neurology Research Center», RAMS
Russian Federation
Russian Federation
S. A. Altynbekov
tate Enterprise «Republican Scientific and Practical Centre for Psychiatry, Psychotherapy and Addiction» MoH
Russian Federation
Russian Federation
G. A. Dzholdygulov
tate Enterprise «Republican Scientific and Practical Centre for Psychiatry, Psychotherapy and Addiction» MoH
Russian Federation
Russian Federation
V. N. Seryakov
tate Enterprise «Republican Scientific and Practical Centre for Psychiatry, Psychotherapy and Addiction» MoH
Russian Federation
Russian Federation
Y. M. Budach
JSC «Chimpharm» Republic of Kazakhstan
Russian Federation
Russian Federation
O. E. Kurilo
JSC «Chimpharm» Republic of Kazakhstan
Russian Federation
Russian Federation
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Review
For citations:
Sariev A.K., Abaimov D.A., Shiryaev M.V., Styrova E.Y., Altynbekov S.A., Dzholdygulov G.A., Seryakov V.N., Budach Y.M., Kurilo O.E. 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»). Pharmacokinetics and Pharmacodynamics. 2013;(2):25-32. (In Russ.)
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