Alessandro de Carvalho Cruz
Brazil
Research Article
Comparative Bioavailability of Two Quetiapine Formulations in Healthy
Volunteers after a Single Dose Administration
Author(s): Eduardo Abib Junior, Luciana Fernandes Duarte, Eunice Mayumi Suenaga, Alessandro de Carvalho Cruz and Clovis Ryuichi NakaieEduardo Abib Junior, Luciana Fernandes Duarte, Eunice Mayumi Suenaga, Alessandro de Carvalho Cruz and Clovis Ryuichi Nakaie
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 bioequival.. View More»
DOI:
10.4172/jbb.1000081