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»)

• Main Authors: A. K. Sariev (Author), D. A. Abaimov (Author), M. V. Shiryaev (Author), E. Y. Styrova (Author), S. A. Altynbekov (Author), G. A. Dzholdygulov (Author), V. N. Seryakov (Author), Y. M. Budach (Author), O. E. Kurilo (Author)
• Format: Book
• Published: LLC "Publisher OKI", 2013-09-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Summary

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.

Item Description

2587-7836
2686-8830