Bioequivalence study of a generic quetiapine in healthy male volunteers

Aim: To study the bioequivalence of a generic quetiapine (Quantia 200(R), manufactured by the Unison Laboratories Co., Ltd., Bangkok, Thailand) and the innovator product (Seroquel(R), AstraZeneca, Macelesfield, UK). Volunteers and methods: The study was a randomized, 2-way crossover design with a 2-week washout period in 24 healthy Thai male volunteers. After a single 200 mg oral dosing, serial blood samples were collected at appropriate interval up to 48 h. Plasma quetiapine concentrations were determined by high-performance liquid chromatography (HPLC). Pharmacokinetic parameters were estimated using the WinNonlin(R) software with noncompartment model analysis. Comparative bioequivalence between the two formulations was determined by analysis of variance (ANOVA) for 2-way crossover design. Results: The mean +/- SD of maximum plasma concentration (C-max), the area under the plasma concentration-time curve from 0 - 48 h (AUC(0-48)) and the area under the plasma concentration-time curve from 0 to infinity (AUC(0-x)) of Quantia 200(R) vs. Seroquel(R) were 886.60 +/- 356.50 vs. 811.34 +/- 323.37 ng/ml; 3,754.41 +/- 1,453.00 vs. 3,420.00 +/- 1,229.6 ng x h/ml and 4,015.35 +/- 1,528.25 vs. 3,769.45 +/- 1,296.69 ng x h/ml, respectively. Time to reach C-max (t(max)) of Quantia 200(R) and Seroquel(R) were 1.08 +/- 0.778 and 1.10 +/- 0.79 h, respectively, and thus not significantly different. The 90% confidence interval of the ratios of the logarithmically transformed of C-max, AUC(0-48) and AUC(0-x) were 98.21 - 124.37%, 94.43 - 117.03% and 94.77 - 116.61% , respectively, which were within the acceptable range of 80 - 125%. Power of the test for C-max, AUC(0-48) and AUC(0-x) was 92.1%, 96.9% and 97.4%. respectively. Conclusion: Quantia 200(R), used in this study, was bioequivalent to Seroquel(R) in terms of both the rate and extent of absorption.