PMID- 18948162
OWN - NLM
STAT- MEDLINE
DCOM- 20090602
LR  - 20151119
IS  - 0278-5846 (Print)
IS  - 0278-5846 (Linking)
VI  - 33
IP  - 2
DP  - 2009 Mar 17
TI  - Pharmacokinetic profiles of extended release quetiapine fumarate compared with 
      quetiapine immediate release.
PG  - 199-204
LID - 10.1016/j.pnpbp.2008.09.026 [doi]
AB  - This 10-day, single-center, open-label, randomized, crossover study compared 
      pharmacokinetic profiles and tolerability of extended release quetiapine fumarate 
      (quetiapine XR) with quetiapine immediate release (quetiapine IR) in patients 
      with schizophrenia, schizoaffective disorder or bipolar disorder. After a 2-day 
      lead-in period during which patients received quetiapine XR 300 mg once daily, 
      patients were randomized to quetiapine IR 150 mg twice daily followed by 
      quetiapine XR 300 mg once daily, or quetiapine XR 300 mg once daily followed by 
      quetiapine IR 150 mg twice daily. Pharmacokinetic parameters were evaluated at 
      the end of each 4-day treatment period at steady state. Vital signs, laboratory 
      values, and adverse events (AEs) were recorded throughout the study. The least 
      squares means (90% confidence interval) of the ratio of the area under the plasma 
      concentration-time curve over a 24 h dosing interval (AUC ([0-24 h])) for 
      quetiapine XR/IR was 1.04 (0.92-1.19) and within the pre-defined range set for 
      equivalence (0.80-1.25). Maximum plasma concentration at steady state (C(max)) 
      was approximately 13% lower for quetiapine XR than for quetiapine IR (495.3 
      versus 568.1 ng/mL), time to reach C(max) (t(max)) was 5 h versus 2 h and mean 
      concentration at the end of 24 h dosing interval (C(min)) was 95.3 versus 96.5 
      ng/mL, respectively. No patients withdrew from the study owing to AEs and there 
      were no serious AEs or deaths related to study medication. No unexpected AEs, 
      changes in vital signs or laboratory values were observed. These findings suggest 
      that modifying the formulation does not change the overall absorption or 
      elimination of quetiapine, and support emerging clinical evidence for the use of 
      quetiapine XR as a once daily treatment in patients initiating therapy or those 
      established on quetiapine IR.
FAU - Figueroa, Carlos
AU  - Figueroa C
AD  - Research Strategy International, Torrance, CA, USA. 
      carlosfigueroa@pasadenaresearch.net
FAU - Brecher, Martin
AU  - Brecher M
FAU - Hamer-Maansson, Jennifer E
AU  - Hamer-Maansson JE
FAU - Winter, Helen
AU  - Winter H
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
DEP - 20081009
PL  - England
TA  - Prog Neuropsychopharmacol Biol Psychiatry
JT  - Progress in neuro-psychopharmacology & biological psychiatry
JID - 8211617
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Dibenzothiazepines)
RN  - 2S3PL1B6UJ (Quetiapine Fumarate)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antipsychotic Agents/*administration & dosage/adverse effects/*pharmacokinetics
MH  - Bipolar Disorder/drug therapy/metabolism
MH  - Cross-Over Studies
MH  - Delayed-Action Preparations
MH  - Dibenzothiazepines/*administration & dosage/adverse effects/*pharmacokinetics
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Psychiatric Status Rating Scales
MH  - Psychotic Disorders/drug therapy/metabolism
MH  - Quetiapine Fumarate
MH  - Schizophrenia/drug therapy/metabolism
MH  - Young Adult
RF  - 350
EDAT- 2008/10/25 09:00
MHDA- 2009/06/03 09:00
CRDT- 2008/10/25 09:00
PHST- 2008/06/20 00:00 [received]
PHST- 2008/09/25 00:00 [revised]
PHST- 2008/09/25 00:00 [accepted]
PHST- 2008/10/25 09:00 [pubmed]
PHST- 2009/06/03 09:00 [medline]
PHST- 2008/10/25 09:00 [entrez]
AID - S0278-5846(08)00301-1 [pii]
AID - 10.1016/j.pnpbp.2008.09.026 [doi]
PST - ppublish
SO  - Prog Neuropsychopharmacol Biol Psychiatry. 2009 Mar 17;33(2):199-204. doi: 
      10.1016/j.pnpbp.2008.09.026. Epub 2008 Oct 9.