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

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ClinicalTrials.gov Identifier: NCT01570959
Recruitment Status : Completed
First Posted : April 4, 2012
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
West-Ward Pharmaceutical ( Roxane Laboratories )

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

Condition or disease Intervention/treatment Phase
Bipolar I Disorder Drug: Quetiapine Fumarate Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Two Period, Two Treatment, Two Way, Steady State Crossover Bioequivalence Study of Quetiapine Fumarate 300 mg Tablets Under Fasting Conditions
Study Start Date : April 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: Quetiapine Fumarate
    300 mg tablet
    Other Name: Seroquel


Primary Outcome Measures :
  1. bioequivalence determined by statistical comparison Cmax [ Time Frame: 10 days ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01570959


Locations
United States, California
Collaborative Neuroscience Network, Inc.
Garden Grove, California, United States, 92845
Synergy Clinical Research Center
National City, California, United States, 91950
United States, Florida
Segal Institute for Clinical Research
North Miami, Florida, United States, 33161
United States, New Jersey
Global Medical Institutes/Princeton Medical Institute
Princeton, New Jersey, United States, 08540
CRI Worldwide
Willingboro, New Jersey, United States, 08046
United States, Texas
Community Clinical Research, Inc.
Austin, Texas, United States, 78754
Claghorn-Lesem Research Clinic, Ltd
Houston, Texas, United States, 77008
Sponsors and Collaborators
Roxane Laboratories

Responsible Party: Roxane Laboratories
ClinicalTrials.gov Identifier: NCT01570959     History of Changes
Other Study ID Numbers: QUET-T300-PVSS
First Posted: April 4, 2012    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs