Crossover Bioequivalence Study of Quetiapine Fumarate 300 mg Tablets Under Steady State Fasted Conditions



Status:Completed
Conditions:Psychiatric, Bipolar Disorder
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 55
Updated:1/25/2018
Start Date:April 2007
End Date:November 2007

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A Two Period, Two Treatment, Two Way, Steady State Crossover Bioequivalence Study of Quetiapine Fumarate 300 mg Tablets Under Fasting Conditions

The objective of this study was to prove the bioequivalence of Roxane Laboratories'
Quetiapine Fumarate 300 mg Tablet under fasted steady state conditions.


Inclusion Criteria:

1. Stable patients with the DSM-IV TR diagnosis of schizophrenia. These patients are to
be identified via psychiatric evaluation and meet DSM-IV TR criteria for schizophrenia
of paranoid (295.30), disorganized (295.10), catatonic (295.20), undifferentiated
(295.90), or residual (295.60) subtype.

2. Patient to have no significant breakthrough symptoms or exacerbations of psychiatric
illness necessitating hospitalization in the 3 months prior to screening.

3. Patient to have a CGI-S score of 3 or less at screening.

4. On a stable regimen of treatment to include quetiapine fumarate for 3 months minimum
prior to screening, and on a dose of quetiapine fumarate totaling 600 mg total per day
for a minimum of 1 month prior to screening. Patients who are on qd dosing of daily
quetiapine fumarate must be willing to convert to 300 mg bid dosing for the duration
of the study.

Exclusion Criteria:

1. All other DSM-IV axis I diagnoses, including schizoaffective disorder,
schizophreniform disorder and/or any other psychiatric diagnoses that in the opinion
of the principal investigator may during the conduct of the trial become a primary
treatment concern, or may interfere in the patients ability to participate in the
trial.

2. Positive test for HIV, Hepatitis B, or Hepatitis C.

3. Treatment with known enzyme altering drugs.

4. History of allergic or adverse response to quetiapine or any comparable or similar
product.
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Houston, Texas 77008
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Austin, Texas 78754
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Garden Grove, California 92845
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National City, California 91950
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North Miami, Florida 33161
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Princeton, NJ
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Willingboro, New Jersey 08046
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