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

Sponsor
Roxane Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT01570959
Collaborator
(none)
56
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Study Details

Study Description

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
  • Drug: Quetiapine Fumarate
N/A

Study Design

Study Type:
Interventional
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 :
Apr 1, 2007
Actual Primary Completion Date :
Nov 1, 2007
Actual Study Completion Date :
Nov 1, 2007

Outcome Measures

Primary Outcome Measures

  1. bioequivalence determined by statistical comparison Cmax [10 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Collaborative Neuroscience Network, Inc. Garden Grove California United States 92845
2 Synergy Clinical Research Center National City California United States 91950
3 Segal Institute for Clinical Research North Miami Florida United States 33161
4 Global Medical Institutes/Princeton Medical Institute Princeton New Jersey United States 08540
5 CRI Worldwide Willingboro New Jersey United States 08046
6 Community Clinical Research, Inc. Austin Texas United States 78754
7 Claghorn-Lesem Research Clinic, Ltd Houston Texas United States 77008

Sponsors and Collaborators

  • Roxane Laboratories

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT01570959
Other Study ID Numbers:
  • QUET-T300-PVSS
First Posted:
Apr 4, 2012
Last Update Posted:
Jan 23, 2018
Last Verified:
Jan 1, 2018
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 23, 2018