Comparative study on the bioequivalence of two formulations of pioglitazone tablet in healthy Thai male volunteers.

Author(s): Sripalakit P, Maphanta S, Neamhom P, Saraphanchotiwitthaya A, Polnok S, Yokubol D

Affiliation(s): Bioequivalence Test Center, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand. pattana9@excite.com

Publication date & source: 2007-12, Drug Dev Ind Pharm., 33(12):1362-8.

Publication type: Comparative Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

The bioequivalence study of two 30 mg pioglitazone formulations was determined in healthy Thai male volunteers after a single dose administration in a randomized cross-over study with a 1-week washout period. Due to the high variability of the rate and extent of absorption of pioglitazone, an add-on subject study was required to assess bioequivalence. Reference product Actos, Takeda Chemical Industries, Ltd., Osaka, Japan) and test product (Glubosil, Silom Medical Co. Ltd., Bangkok, Thailand) were given to 35 volunteers after overnight fasting. Blood samples were collected at specified time intervals. Plasma was analyzed for pioglitazone concentration using a validated HPLC method. Pharmacokinetic parameters were compared between test and reference products from plasma concentration-time profile by using non-compartment analysis. The statistical comparison of C(max) and AUC(0-t), AUC(t-infinity) clearly indicated that no significant difference in two products of pioglitazone tablets in add-on subject study. The 90% confidence intervals for the mean ratio (test/reference) of C(max) and AUC(0-t), AUC(t-infinity) were within the Thailand Food and Drug Administration acceptance range. Based on the pharmacokinetic and statistical results of this study, we can conclude that Glubosil is bioequivalent to Actos, and that two products can be considered interchangeable in medical practice.