Comparative Bioavailability of Two Quetiapine Formulations in Healthy Volunteers after a Single Dose Administration
- *Corresponding Author:
- Dr. Eduardo Abib Junior
Scentryphar Clinical Research, 885, Barão de Itapura ave
Campinas, SP - Brazil, 13020-420
Tel: (19) 3232-6350
Fax: (19) 3231-6715
E-mail: [email protected]
Received Date: July 20, 2011; Accepted Date: August 30, 2011; Published Date: September 01, 2011
Citation: Junior EA, Duarte LF, Suenaga EM, de Carvalho Cruz A, Nakaie CR (2011) Comparative Bioavailability of Two Quetiapine Formulations in Healthy Volunteers after a Single Dose Administration. J Bioequiv Availab 3: 178-181. doi: 10.4172/jbb.1000081
Copyright: © 2011 Junior EA, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
The study was performed to compare the bioavailability of two quetiapine 25 mg tablet formulations: the test formulation was quetiapine fumarate (kitapen®) manufactured by Cobalt Pharmaceuticals, Canada/ Arrow Farmacêutica Ltda* (Erowlabs). Seroquel® (quetiapine) from Astrazeneca Brazil was used as reference formulation. The study was conducted open with randomized two period crossover design and one week wash out period in 64 volunteers of both sexes. Plasma samples were obtained over a 48 hour interval. Quetiapine was analyzed by LC-MS-MS in the presence of quetiapine-D8 as internal standard. Plasma samples were obtained over a 48 hour interval. Quetiapine was analyzed by LC-MS-MS in the presence of quetiapine-D8 as internal standard. The mean ratio of parameters Cmax and AUC 0-t and 90% confidence intervals of correspondents were calculated to determine the bioequivalence. The means AUC 0-t for test and reference formulation were 432.41 ng.h/mL and 412.20 ng.h/mL, for AUC 0-∞ were 440.06 ng.h/mL and 418.90 ng.h/mL and, for Cmax 126.94 ng/mL and 108.71 ng/mL, respectively. Geometric mean of quetiapine (kitapen®)/Seroquel® 25 mg individual percent ratio was 97.68% AUC 0-t , 97.47% for AUC 0-∞ and 90.68% for C max . The 90% confidence intervals were 92.67 – 102.96%, 92.53 – 102.67%, 83.37 – 98.64%, respectively. Since the 90% confidence intervals for C max , AUC 0-t and AUC 0-∞ were within the 80 – 125% interval proposed by Food and Drug Administration, it was concluded that quetiapine (kitapen®) 25 mg tablet was bioequivalent to Seroquel® 25 mg tablet according to both the rate and extent of absorption.