310BIOEQUIVALENCE STUDY OF SINGLE DOSE PIOGLITAZONE TABLETS 45 MG COMPARING WITH ACTOS (PIOGLITAZONE HCL) TABLETS 45 MG, IN HEALTHY, ADULT, HUMAN SUBJECTS UNDER FASTING CONDITIONThe purpose of the study is a)To compare oral bioavailability of single dose pioglitazone tablets 45 mg comparing with reference drug Actos® (pioglitazone HCl) tablets 45 mg and b) To monitor the safety and tolerability of a single dose of pioglitazone 45 mg tablets when administered in healthy, adult, human subjects under fasting condition. An open label, balanced, analyst blind, randomized, two-treatment, two-period, two sequence, single dose, crossover bioequivalence study on 12 healthy, adult, human subjects under fasting condition. An oral dose of Reference (R) or Test product (T) was administered as per the randomization schedule. Subjects were received the alternate „treatments‟ in both the periods in such a way that each subject will receive the „treatment‟ test and reference each, at the end of the study. For the analysis of bioequivalence, including Cmax, (AUC0-t), and (AUC0-∞), the Blood samples (1×5 mL) was withdrawn pre-dose and at 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 14.00, 16.00, 20.00 24.00 and 48.00 hours post dose. The 90 % confidence interval for Cmax, AUC0-t and AUC0-∞ of Pioglitazone forms the basis for concluding the bioequivalence of Pioglitazone in product R and T. The 90% confidence interval for the log-transformed pharmacokinetic parameters Cmax, AUC0-t & AUC0-∞ for Test vs. Reference were found to be 86.40% to 127.82%, 81.83% to 115.09% and 96.04% to 112.75% respectively. And the least square mean ratios for test / reference product for Cmax, AUC0-t and AUC0-∞ were 105.09%, 97.05% and 96.04% respectively. A single dose pioglitazone tablets 45 mg did not meet the bioequivalence criteria of 80.00 % to 125% for Cmax, when compared with reference product actos® (pioglitazone HCl) tablets 45 mg.atulsuhas@gmail.comResearch4112013Pioglitazone,Bioavailability,Bioequivalence,PharmacokineticsSuhas S. AgeySVKM‟s Narsee Monjee Institute of Management Science (NMIMS), Shirpur, Dhule, Maharashtra, India-425405.