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Single Dose Relative Bioavailability And Safety Of A New Quetiapine Fumarate Extended Release Formulation: Is There A Food Effect On XR Performance | 8295
ISSN: 0975-0851

Journal of Bioequivalence & Bioavailability
Open Access

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Single dose relative bioavailability and safety of a new quetiapine fumarate extended release formulation: Is there a food effect on XR performance

International Conference and Exhibiton on Pharmaceutical Regulatory Affairs

Francisco E. Estevez-Carrizo

ScientificTracks Abstracts: JBB

DOI: 10.4172/0975-0851.1000107

Q uetiapine is a dibenzothiazepine derivative that has been established as an eff ective ther- apy for schizophrenia and bipolar disorder. Th e bioequivalence and safety of a new XR formulation of quetiapine 300 mg (Quetia? XR, Gautier, Uruguay) was assessed versus an XR globally marketed product in fasting and fed conditions. Two single-dose, two-way, crossover, in vivo, fasting and fed studies were performed. One tablet of quetiapine XR 300 mg (test and reference formulations) was administered as a single oral dose, and blood samples were collect- ed throughout 36 hours. Th e AUC0-36 , AUC0-_, Cmax and Tmax were calculated. Bioequiva- lence was concluded if the 90% confi dence interval (90% CI) of the T/R ratios for area under the curve (AUC) and peak concentration (Cmax) fell within 0.80 and 1.25. Adverse events were de- termined using clinical assessment, laboratory results, monitoring of vital signs and by record- ing any sign or symptom reported during the study. Forty healthy volunteers were enrolled and completed the studies. Results showed that the ratio of GM for AUC and Cmax in posprandial state met bioequivalence criteria (0.80-1.25). Th e extent and rate of absorption as well as dispo- sition of quetiapine XR was aff ected by food. Hypotension, dry mouth, dizziness, headache and nausea were the most frequent adverse events found in the studies. As a conclusion: this single dose studies showed that the test product met regulatory criteria for bioequivalence and that both formulations were generally well tolerated. As per the present study food had an apparent eff ect the bioavailability and disposition of quetiapine
In the 80 ́s, Dr. Estevez-Carrizo got his M.D. degree and also graduated as specialist in Pharmacology and Therapeutics at the State University, Montevideo. Got the Ph.D. in Clinical Pharmacology at the Karolinska Institute, Stockholm and was Fullbright Scholar at the Pennstate University. In 1993 he was appointed Associate Professor of Pharmacology and Therapeutics at the State University. In 1997, visiting professor at the School of Pharmacy of the University of Minnesota. Since 2002 he is full Professor of Clinical Pharmacology at the University of Montevideo. His main scienti fi c interest is on BABE studies, publishing more than 50 peer reviewed papers