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

January 19, 2018 updated by: Roxane Laboratories

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
bioequivalence determined by statistical comparison Cmax
Time Frame: 10 days
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roxane Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (ACTUAL)

November 1, 2007

Study Completion (ACTUAL)

November 1, 2007

Study Registration Dates

First Submitted

March 28, 2012

First Submitted That Met QC Criteria

April 2, 2012

First Posted (ESTIMATE)

April 4, 2012

Study Record Updates

Last Update Posted (ACTUAL)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 19, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QUET-T300-PVSS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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